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BioRegulations Home   Health Biotechnology   Environmental Biotechnology   Agricultural Biotechnology   Industrial Biotechnology BioGateway BioBasics BioStrategy BioGov		Home > Regulation of Health Biotechnology > Regulation of Drugs and Biologics Regulation of Drugs and Biologics ADR Expedited Reporting Summary for ADRs Occuring During Clinical Trials Health Canada During a clinical trial the sponsor is required to inform Health Canada of any serious, unexpected adverse drug reaction that has occurred inside or outside Canada.   A completed ADR Expedited Reporting Summary Form should be attached to the front of the report. [DETAILS] Animal Tissue: Category IV Health Canada If the product contains animal tissue or animal tissue was used as an intermediate during manufacturing, complete the Animal Tissue Form attached to the relevant Category IV Monograph. [DETAILS] Animal Tissue: Labelling Standard Health Canada This form concerning labelling standards asks the sponsor to describe how, if at all, they make use of animal materials in any way in the product(s) specified in their DIN application. [DETAILS] Authority to Sell Fee Reduction Request and Attestation Form Health Canada A person who files a submission, supplement or application may apply for a reduction in the fees payable. Payment of $1000 and information supporting the request for a reduction must be included with the application. A request for a reduction of fees and the accompanying information should be included with the submission in a separate section which can be severed from the submission to facilitate separate review by the Cost Recovery Office. [DETAILS] Biologics & Radiopharmaceuticals - Acts & Regulations Health Canada The Biologics and Genetics Therapies Directorate (BGTD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the biologic or radiopharmaceutical drug and medical device combinations offered for sale in Canada are safe, effective and of high quality. [DETAILS] Biologics & Radiopharmaceuticals - Application/Submission Information - Forms Health Canada Subject to the type of application, forms accessible from this page must be completed by manufacturers or sponsors and accompany drug submissions filed to the Biologics and Genetic Therapies Directorate. The forms for all application types will be examined by BGTD for administrative completeness. [DETAILS] Biologics & Radiopharmaceuticals - Guidance Documents Health Canada The following guidance documents have been prepared to assist in the interpretation of the policies governing statutes and regulations. [DETAILS] Biologics and Genetic Therapies Directorate - Contact Us Health Canada The Biologics and Genetic Therapies Directorate (BGTD) is the regulatory authority in Canada which is responsible for ensuring the safety, efficacy and quality of all biologics and radiopharmaceuticals for human use, marketed in Canada. [DETAILS] Certification: Changes in Manufacturer's Name and/or Product Name Health Canada The purpose of this form is to indicate any administrative changes being made to a product, such as the product name or manufacturer's name. [DETAILS] Certified Product Information Document - Chemical Entities (CPID-CE) Health Canada The CPID-CE template should be completed to provide a condensed summary of the key Quality information for New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) containing drug substances and their corresponding products of synthetic or semi-synthetic origin that are filed with Health Canada pursuant to Part C, Division 8 of the Food and Drug Regulations. This would exclude submissions for Biotechnological / Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs. [DETAILS] Clinical Trial Site Information Form Health Canada A separate form for each clinical trial site must be completed by the sponsor and filed with Health Canada. All fields must be completed prior to submitting this form to Health Canada. [DETAILS] DMF Fee form Health Canada Drug Master File (DMF) Application Fee Form [DETAILS] Draft Comprehensive Summary - Bioequivalence (CS-BE) Health Canada This draft document is meant to assist applicants in the preparation of drug submissions that include pivotal comparative bioavailability studies, and in particular those submissions in the Common Technical Document (CTD) format developed by the International Conference on Harmonization (ICH). [DETAILS] Draft Guidance for Industry: Preparation of Drug Submissions in the eCTD Format Health Canada The purpose of this guidance is to integrate the eCTD format within the Canadian drug registration framework by electronic filing requirements for drug submissions filed pursuant to Division 8, Part C of the Food and Drug Regulations. [DETAILS] Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format Health Canada This guidance covers the preparation and filing of CTD-formatted drug submissions for human use, filed pursuant to Division 8, Part C of the Food and Drug Regulations. [DETAILS] Draft Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) Health Canada This document is intended to provide guidance with regard to the Quality (i.e., Chemistry and Manufacturing) portion of New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) containing drug substances and their corresponding products of synthetic or semi-synthetic origin, excluding Biotechnological/Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs, that are filed with Health Canada pursuant to Division C.08 of the Food and Drug Regulations. [DETAILS] Drug Establishment Licence Application: Form and Instructions Health Canada A Drug Establishment Licence is required for all businesses in Canada engaged in any of the six activities related to the manufacturing and testing of all drugs in dosage form and bulk intermediates of Schedule C (radiopharmaceutical) and D (biological) drugs. The six activities are: fabrication, packaging/labelling, importation, distribution, wholesale, and testing. [DETAILS] Drug Establishment Licence: Fee Reduction Request Health Canada This form must be returned by all establishments whether or not you are requesting a Fee Reduction. [DETAILS] Drug Product Ingredient Form Health Canada In your 2004 Annual Notification package, a Notice was enclosed advising that Health Canada was considering requesting all DIN holders and manufacturers of radiopharmaceuticals to provide a current listing of their product formulation, including medicinal and non-medicinal ingredients, and information concerning the sources of these ingredients (such as animal - species, age, country of origin, and tissues and fluids).  This is to inform you that Health Canada is now requesting this information. [DETAILS] Drug-Drug Interactions: Studies In Vitro and In Vivo Health Canada This guidance document provides suggestions to industry scientists and Therapeutic Products Programme evaluators concerning current approaches to the conduct and regulatory review of in vitro and in vivo studies addressing drug interactions. [DETAILS] Drugs - Acts & Regulations Health Canada The Therapeutic Products Directorate (TPD) applies the Food and Drug Regulations and the Medical Devices Regulations under the authority of the Food and Drugs Act to ensure that the pharmaceutical drugs and medical devices offered for sale in Canada are safe, effective and of high quality. [DETAILS] Drugs - Application/Submission Information - All Forms Health Canada Health Canada's Therapeutic Products Directorate [DETAILS] Establishment Licences Health Canada Drugs, medical devices, and exporting [DETAILS] FAQs - Health Products and Food Branch Inspectorate Health Canada The Inspectorate is responsible for the management of inspection, investigation, monitoring activities and enforcement strategies related to the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of regulated health products for human and veterinary use. [DETAILS] Food and Drug Regulations Department of Justice Canada Regulations respecting food and drugs. [DETAILS] Food and Drugs Act Department of Justice Canada An Act respecting food, drugs, cosmetics and therapeutic devices. [DETAILS] Form IV: Patent List - Pertaining to Patented Medecines Patented Medicines (Notice of Compliance) Regulations - First Person Application Health Canada At the time of filing of a submission for a Notice of Compliance (NOC), the first person may submit a list of granted patents which, in the belief of the first person, contain a claim for the medicine itself or a claim for the use of the medicine and which should embody the drug in respect of which the submission for NOC has been filed. A separate Form IV-Patent List should be provided for each such patent. [DETAILS] Form V: Declaration re: Patent List Patented Medicines (Notice of Compliance) Regulations - Second Person Application Health Canada When a second person files a submission for a NOC and compares or makes reference to another drug for purposes of demonstrating bioequivalence for which a patent list has been submitted, the second person must comply with subsection 5(1) of the Patented Medicines (Notice of Compliance) Regulations. A second person who files a submission for a drug containing a medicine that is found in another drug for which a patent list has been submitted, in the same route of administration, and with a comparable strength and dosage form, must comply with subsection 5(1.1). [DETAILS] Frequently Asked Questions: Product Monograph Guidance Document and Standard Templates Health Canada This Frequently Asked Questions document is intended to provide clarification to sponsors of the way in which Health Canada implements the revised Product Monograph Guidance Document and Standard Product Monograph Templates. This document will not address issues relating to the availability or dissemination/distribution of the product monograph. [DETAILS] Good Manufacturing Practices Health Canada Part of the Health Products and Food Branch Inspectorate (Inspectorate) program is to conduct inspections of sites that are involved in activities covered by the Establishment Licensing framework. These inspections are conducted to verify the compliance of these sites with the Good Manufacturing Practices (GMP) Regulations (Division 2 of the Food and Drugs Regulations) which is a requirement for the issuance of an establishment licence or for the inclusion of a foreign site on the establishment licence. [DETAILS] Guidance and Questions and Answers for Drug Product Ingredient Form Health Canada Guidance and Questions and Answers document with instructions for completion and return of the Drug Product Ingredient Form, and information on this request. [DETAILS] Guidance Document on Establishment Licensing Fees Health Canada Part III of this guidance document provides an overview of the establishment licensing fees, including the proposed fee matrix and examples of how fees would be calculated for various specific establishments. [DETAILS] Guidance For Industry - Changes in Product-Specific Facility Information Health Canada The purpose of this document is to provide clear guidance to the biological drug industry regarding the inclusion of product-specific facility information in drug submissions containing a Quality component (chemistry and manufacturing). This guidance document should be considered in the preparation of all submissions containing a chemistry and manufacturing component which requires facility information, i.e., New Drug Submissions (NDSs), Supplemental New Drug Submissions (S/NDSs) and Biological DIN Applications (DINBs). [DETAILS] Guidance for Industry - Management of Blood Establishment Submissions Health Canada This Guidance is intended to provide clarification to sponsors of the way in which the Biologics and Genetic Therapies Directorate (BGTD) will manage information and material submitted by sponsors in accordance with the Food and Drugs Act and Regulations, for blood establishments. [DETAILS] Guidance for Industry: Drug Submission Status Requests: Therapeutic Products Directorate Health Canada The following outlines the process drug submission sponsors should follow when making inquiries to the Therapeutic Products Directorate (TPD) about the status or progress of their human drug submissions. [DETAILS] Guidance for Industry: Management of Drug Submissions Health Canada This guidance is intended to provide clarification to sponsors of the way in which the Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) manage information and material submitted by sponsors in accordance with the Food and Drugs Act and Regulations. [DETAILS] Guidance for Industry: Patented Medicines (Notice of Compliance) Regulations Health Canada This document provides further instructions on the completion of Forms IV-Patent List and Form V- Declaration re: Patent List. [DETAILS] Guidance for Industry: Product Monograph Health Canada The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. [DETAILS] Guideline for Preparation of Drug Identification Number Submissions Health Canada The Guideline for Preparation of DIN Submissions outlines the information normally needed to establish quality, safety and efficacy of drug products according to product type. In addition to the basic application and certification requirements, the applicant need only refer to that section of this guideline that applies to the product type. [DETAILS] Guidelines for Preparation of a New Drug Submission for Products Used for Estrogen-Progestin Replacement Therapy in Menopause (HRT) Health Canada All HRT drugs of this classification which are considered to be in New Drug status are subject to the requirements of Division 8 of the Food and Drug Regulations, in particular in Canada should meet the requirements of Section C.08.002 of these Regulations and must be demonstrated to be safe and effective for each of the indications proposed for inclusion in the Product Monograph. The New Drug Submission (NDS) should be structured according to current guidelines and should contain the expected data outlined in general and specific guidelines. [DETAILS] HC SC 3011: Drug Application for: Human, Veterinary, or Disinfectant Drugs and Clinical Trial Applications/Attestation Health Canada The attached Drug Submission Application form is designed to assist manufacturers and sponsors in submitting information required to initiate the evaluation of any one of the following types of submissions: Clinical Trial Application (human drugs) Clinical Trial Application Amendment (human drugs) Investigational New Drug Submissions (veterinary drugs) New Drug Submission Supplemental New Drug Submission Abbreviated New Drug Submission Supplemental Abbreviated New Drug Submission Notifiable Change Drug Identification Number (DIN) Application Administrative Change (only applies to manufacturer/sponsor and/or product name change and licensing agreements). [DETAILS] Health Products and Food Branch (HPFB) Inspectorate - Drugs Health Canada The Health Products and Food Branch Inspectorate (Inspectorate) has the legislative/regulatory authority to conduct compliance and enforcement activities including: the delivery of inspections, investigations, most establishment licensing and related laboratory analysis functions for the HPFB. It also has a responsibility to foster partnerships in the regulatory community, including our international, federal and provincial partners. [DETAILS] How to Pay Fees Health Canada Drug Cost Recovery: Submission Evaluation, Drug Master File (DMF) Registration, Authority to sell Drugs, Drug Establishment Licences and Export Certificates. [DETAILS] Issue Analysis - Patent Application Filing Dates, Patented Medicines (Notice of Compliance) Regulations Health Canada This letter is to inform you that, following consultations, the Therapeutic Products Directorate (TPD) has decided not to implement the amendments proposed to the Guidance for Industry: Patented Medicines (Notice of Compliance) Regulations as outlined in our letter dated February 12, 2001. As per the current policy, the use of a priority date, or a claim date to meet the timing requirements under subsection 4(4) of the Patented Medicines (Notice of Compliance) Regulations will continue to be rejected. [DETAILS] Labelling Standard and Category IV Submission Check List Health Canada A list of forms/documents that should accompany the Labelling Standard or Category IV Monograph Submission. [DETAILS] Overview of the Canadian Federal Drug Review Process Health Canada Overview of the Canadian Federal Drug Review Process [DETAILS] Preparation of Human New Drug Submissions Health Canada This guideline is to be used in the preparation of Human New Drug Submissions for presentation to the Drugs Directorate in compliance with the requirements of Division 8 of Part C of the Food and Drug Regulations. [DETAILS] Product Monograph Certification Form Health Canada This Product Monograph certification form certifies that the Product Monograph sent at final clearance reflects accurately the final accepted version. [DETAILS] Proposed revision to Guidance for Industry: Patented Medicines (Notice of Compliance) Regulations Health Canada The purpose of these amendments is to allow for the use of either the filing date of a patent application in Canada (pursuant to section 28 of the Patent Act) or, if applicable, the priority filing date (pursuant to section 28.1- 28.4 of the Patent Act) to stand as the “filing date” referred to in subsection 4(4) of the Patented Medicines (Notice of Compliance) Regulations. In accordance with the proposed changes, the first person would indicate the appropriate date on the Form IV: Patent List. [DETAILS] Protocol Synopsis & Evaluation Health Canada The IND Protocol Summary module of the PCERT is tailored to provide a detailed summary of the protocol information required for the evaluation of the clinical trial(s) proposed in Canada. Information should be summarized under the various headings provided, where applicable. [DETAILS] Qualified Investigator Undertaking Health Canada An undertaking must be completed by the qualified investigator responsible for the conduct of the clinical trial at the site specified below. The completed undertaking must be retained by the clinical trial sponsor for a period of 25 years. Please note that the Qualified Investigator Undertaking should not be submitted to Health Canada unless requested. [DETAILS] Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) (QOS-CE (DINA)) Health Canada The Quality Overall Summary (QOS) is a summary of the Quality Body of Data. This QOS-CE (DINA) template can be used by sponsors to summarize the Quality information for Applications for Drug Identification Number Submissions (DINAs) containing drug substances and their corresponding products of synthetic or semi-synthetic origin that are filed with Health Canada pursuant to Part C, Division 1 (C.01.014) of the Food and Drug Regulations, that are not subject to Part C, Division 8 of the Regulations. This would exclude submissions for Biotechnological/Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs. [DETAILS] Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Bioavailability Studies) (QOS-CE (CTA - BA)) Health Canada A Quality Overall Summary (QOS) is part of a drug submission organized according to the International Conference on Harmonization (ICH) Common Technical Document (CTD) format. The QOS represents a summary that follows the scope and the outline of the Quality Body of Data of the submission. [DETAILS] Quality Overall Summary - Chemical Entities (Clinical Trial Applications - Phase II/III) (QOS-CE (CTA - Phase II/III)) Health Canada A Quality Overall Summary (QOS) is part of a drug submission organized according to the International Conference on Harmonization (ICH) Common Technical Document (CTD) format. The QOS represents a summary that follows the scope and the outline of the Quality Body of Data of the submission. [DETAILS] Quality Overall Summary - Chemical Entities (Clinical Trial Applications Phase I) (QOS-CE (CTA - Phase I)) Health Canada A Quality Overall Summary (QOS) is part of a drug submission organized according to the International Conference on Harmonization (ICH) Common Technical Document (CTD) format. The QOS represents a summary that follows the scope and the outline of the Quality Body of Data of the submission. [DETAILS] Quality Overall Summary - Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions) (QOS-CE (NDS/ANDS)) Health Canada A Quality Overall Summary (QOS) is part of a drug submission organized according to the International Conference on Harmonization (ICH) Common Technical Document (CTD) format. The QOS represents a summary that follows the scope and the outline of the Quality Body of Data of the submission. [DETAILS] Research Ethics Board Attestation Health Canada An attestation must be completed by the Research Ethics Board that reviewed and approved the clinical trial protocol and informed consent form for this clinical trial at the site specified below. The completed attestation must be retained by the clinical trial sponsor for a period of 25 years. Please note that the Research Ethics Board Form should not be submitted to Health Canada unless requested. [DETAILS] Submission Certification: Category IV Drug Health Canada A submission for a DIN should contain the following information for review: a completed Drug Submission Application, Health Canada HPB form 3011, (Appendix A, Guideline on Preparation of DIN Submissions), including proposed Canadian labels and prescribing information or a package insert where applicable a completed DIN Submission Certification (Appendix C, Guideline on Preparation of DIN Submissions) or Category IV Drug Submission Certification (Appendix D, Guideline on Preparation of DIN Submissions) as appropriate specific product type information as specified in Sections I - XVII, Guideline on Preparation of DIN Submissions. [DETAILS] Submission Certification: DIN Health Canada A submission for a DIN should contain the following information for review: a completed Drug Submission Application, Health Canada HPB form 3011, (Appendix A), including proposed Canadian labels and prescribing information or a package insert where applicable a completed DIN Submission Certification (Appendix C) or Category IV Drug Submission Certification (Appendix D) as appropriate specific product type information as specified in Sections I - XVII. [DETAILS] Submission Certification: NDS, SNDS, NC Health Canada A completed Submission Certification Form is required with all original and solicited information and material related to New Drug Submissions, Supplemental New Drug Submissions and Notifiable Changes. This includes the original submission, submission updates, and responses to Screening Deficiency Notices, Notices of Deficiency, and Notices of Noncompliance. [DETAILS] Submission Fee Application Form Health Canada Section 1 "Submission Description" must be completed for every submission. In addition, depending on your submission type, you may have to complete one other Section: For an administrative change submission complete Section 1 only For a New Drug Submission (NDS) complete Section 2. For a Supplemental New Drug Submission (SNDS) complete Section 3. For an Abbreviated New Drug Submission (ANDS), Supplemental Abbreviated New Drug Submission (SANDS) complete Section 4. For an application to remove a drug from Schedule F to the Food and Drug Regulations, complete Section 5. For a Drug Identification Number (DIN) submission complete Section 6. [DETAILS] Therapeutic Products Directorate - Contact Information Health Canada Health Products and Food Branch   TPD-General [DETAILS] Therapeutic Products Directorate - Drugs Health Canada Information on the regulation of drugs in Canada. [DETAILS] Traditional Herbal Medicines Health Canada The purpose of this guideline is to describe the conditions under which herbs may be accepted as medicinal ingredients in a THM, and to assist manufacturers in completing an application for a Drug Identification Number (DIN) and in labelling products that fall within this category. This guideline notes requirements that are specific to traditional herbal medicines. Other relevant requlatory, guideline and policy requirements must also be met. [DETAILS] Biologics & Radiopharmaceuticals Health Canada A biologic is a drug that is prepared using a biological starting or source material (e.g. derived from a microorganism, virus, animal, human, or plant), and using for example, either conventional manufacturing methods, recombinant DNA technology, and/or other novel approaches. Some examples of biologics include vaccines, blood and its derivatives, certain hormones, and enzymes, recombinant DNA products, gene therapies, and transgenics. Biologics make up one large category of drugs; the other major category of drugs is pharmaceuticals, or synthetic drugs made from chemicals. [DETAILS] Biologics & Radiopharmaceuticals - Application/Submission Information - Templates Health Canada In order to help expedite the review process, manufacturers or sponsors are expected to summarize drug submission data related to quality, or safety and efficacy, using the following WordPerfect® or MS Word templates, as appropriate, with drug submissions filed to the Biologics and Genetic Therapies Directorate. [DETAILS] Canadian Environmental Protection Act, 1999 Department of Justice Canada Provides a link to the Canadian Environmental Protection Act, 1999. References are included for biotechnology pertaining to the protection of the environment. [DETAILS] Clinical Investigation of Medicinal Products in the Pediatric Population ICH Topic E11 Health Canada It is the goal of this guidance to encourage and facilitate timely pediatric medicinal product development internationally. The guidance provides an outline of critical issues in pediatric drug development and approaches to the safe, efficient, and ethical study of medicinal products in the pediatric population. [DETAILS] Clinical Trial Applications for Comparative Bioavailability Studies for Pharmaceuticals Health Canada Sponsors must file a Clinical Trial Application (CTA) with the Health Products and Food Branch (HPFB) of Health Canada prior to conducting a clinical drug trial, including a comparative bioavailability study. [DETAILS] Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations Health Canada This guidance document provides information about how to establish and conduct bioavailability studies for modified-release (MR) dosage forms of oral drugs that are used for systemic effects. The information contained in this guidance document deals with drugs that have uncomplicated characteristics (as described in Conduct and Analysis of Bioavailability and Bioequivalence Studies: Part A-Oral Dosage Formulations Used for Systemic Effects). [DETAILS] Conduct and analysis of bioavailability and bioequivalence studies Part A: Oral Dosage Formulations Used for Systemic Effects Health Canada This guidance document provides information about how to establish and conduct bioavailability studies for conventional formulations of oral drugs that are used for systemic effects. The information contained herein deals with conventional formulations of oral drugs that have uncomplicated characteristics. [DETAILS] Disinfectant Guidelines Health Canada This guideline is provided to assist applicants: in identifying those antimicrobial products which are classified as disinfectant drugs and/or disinfectant pest control products, in preparing complete application packages, in understanding the submission options available, and in labelling these products to meet Canadian regulatory requirements. [DETAILS] Draft Guidance for Clinical Trial Sponsors Quality (Chemistry and Manufacturing): Clinical Trial Applications Health Canada This document is intended to provide guidance with regard to the Quality (i.e., Chemistry and Manufacturing) portion of Clinical Trial Applications (CTA's), excluding Biotechnological/Biological (Schedule D) and Radiopharmaceutical (Schedule C) drugs. [DETAILS] Draft Guidance for Industry: Bioequivalence Requirements: Comparative Bioavailability Studies Conducted in the Fed State Health Canada This draft guidance presents the most current position of the Therapeutic Products Directorate (TPD) with respect to requirements for comparative bioavailability (BA) studies conducted in the fed state for purposes of demonstrating bioequivalence (BE) of two solid oral dosage forms. [DETAILS] Draft Guidance for Industry: Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format Health Canada The purpose of this guidance is to define the Common Technical Document (CTD) format of drug submissions which rely on comparative bioavailability studies to establish safety and efficacy. [DETAILS] Draft Guidance for Industry: Use of Metabolite Data in Comparative Bioavailability Studies Health Canada Purpose: To define when the use of metabolite data rather than data on the parent drug is acceptable for comparative bioavailability studies. [DETAILS] Drugs - Application/Submission Information - Policies Health Canada Policy documents are interpretations of the purpose and intent of the Food and Drugs Act and Regulations. [DETAILS] Drugs - Fees Health Canada Cost recovery is a federal government policy intended to promote more business-like and equitable management of government programs. The policy stipulates that specific individuals or firms, who benefit directly from or cause government activity should bear some or all of the cost of those activities. [DETAILS] Guidance for Clinical Trial Sponsors: Clinical Trial Applications Health Canada This guidance document is not an exhaustive description or explanation of Part C, Division 5 of the Regulations, but rather, outlines the application requirements for sponsors wishing to conduct clinical trials with drugs in humans. [DETAILS] Guidance for Industry: Clinical Development of Steroidal Contraceptives Used by Women Health Canada This guidance document addresses the development of contraceptive products, intended for use by women during their reproductive years, which contain sex steroids as active ingredient(s). [DETAILS] Guidance to Establish Equivalence or Relative Potency of Safety and Efficacy of a Second Entry Short-Acting Beta2-Agonist Metered Dose Inhaler Health Canada This guidance document details the recommendations to second entry applicants on methods to establish the equivalence or relative potency of the safety and efficacy of short-acting, beta2-agonist bronchodilators delivered by inhalation aerosol (metered dose inhaler; MDI). [DETAILS] Guidance to Industry: Preparation of Submissions in the Electronic Common Technical Document or eCTD Format - Questions and Answers Health Canada The International Pharmaceutical Common Technical Document (CTD) was developed along with its electronic equivalent, the eCTD. Canada is committed to align its technology to the eCTD, making this the preferred format for electronic drug submissions in Canada. [DETAILS] Guidance when Developing Therapeutic Regimens for the Eradication of Helicobacter pylori in GI Diseases Health Canada The purpose of this document is to suggest elements for consideration when designing clinical trials dealing with eradication of H. pylori in GI diseases and to outline elements to be reviewed in the submissions. [DETAILS] Guideline for Low Dilution Multi-Ingredient Homeopathic Products with Indications for Use Health Canada This Guideline applies to products in granule, globule, pellet, tablet, powder, liquid, lotion and ointment form for oral and topical use. This Guideline does not include ingredients which are: prohibited under Food and Drug Regulations; listed in Schedules C, D, G, or H to the Food and Drugs Act; listed in Schedule F to the Food and Drug Regulations; listed in the schedule to the Narcotic Control Act. [DETAILS] Guidelines for the Toxicological Evaluation of Contraceptive Steroids Health Canada The guidelines provide specific recommendations on the design and conduct of preclinical studies that are essential to confidently assess the toxicity of contraceptive steroids. [DETAILS] Haemodialysis Solutions Health Canada This monograph applies to products in the form of liquid concentrate that are intended to be used for acute and chronic haemodialysis. [DETAILS] Health Canada Addendum to ICH Guidance Document E11: Clinical Investigation of Medicinal Products in the Pediatric Population Health Canada This addendum is directed towards new indications for approved medicinal products, new active substances, new formulations or combinations of approved medicinal products, including drugs, biological therapies and interventions, that are intended to be used in the pediatric population. [DETAILS] Health Products and Food Branch Inspectorate Health Canada The Inspectorate is responsible for the management of inspection, investigation, monitoring activities and enforcement strategies related to the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of regulated health products for human and veterinary use. [DETAILS] Health Products and Food Branch Inspectorate - About Us Health Canada The Inspectorate is responsible for the management of inspection, investigation, monitoring activities and enforcement strategies related to the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of regulated health products for human and veterinary use. [DETAILS] Inclusion of Women in Clinical Trials Health Canada The intention of this guideline is to encourage the inclusion of women, especially those of child-bearing potential at the earliest stages of drug development, in order (i) to ensure that potential sex-related differences are being identified and taken into consideration when planning Phase III pivotal trials and (ii) to generate appropriate data to inform both physicians and potential users concerning sex-related characteristics of a new drug. [DETAILS] Information for Applicants wishing to obtain Market Authorization for a Natural Health Product Health Canada A Drug Identification Number (DIN) will no longer be issued for natural health products (NHPs) under the Food and Drug Regulations. Instead, market authorization for a natural health product may be obtained by sending a Product License submission package to the Natural Health Products Directorate to be approved under the Natural Health Products Regulations. [DETAILS] Issue Analysis Summary - Patented Medicines (Notice of Compliance) Regulations Health Canada The purpose of this Issue Analysis Summary document is to provide a summary analysis of issues raised through comments by industry stakeholders which were received by the TPP in response to the draft Guideline for the Patented Medicines (Notice of Compliance) Regulations [SOR/98-166]. [DETAILS] New Substances Notification Regulations Department of Justice Canada Regulations respecting notification of substances new to Canada. [DETAILS] New Substances Notification Regulations (Organisms) (Proposed Regulations) Government of Canada The proposed Regulations are part of a new regulatory structure that divides the NSNR into two distinct Regulations: 1. New Substances Notification Regulations (Chemicals and Polymers), which will apply to chemicals (including biochemicals) and polymers (including biopolymers) that are for a use not covered under other federal legislation listed in Schedule 2 of the Act; and 2. New Substances Notification Regulations (Organisms), which will apply to living organisms that are for a use not covered under other federal legislation listed in Schedule 4 of the Act. These regulations are expected to come into force in early 2005. [DETAILS] Non-Medicinal Ingredients Nomenclature Health Canada The following nomenclature is proposed for use on labels, in product monographs, and in other printed material wherever the disclosure of non-medicinal ingredients is required. [DETAILS] Notice to Industry - Bioequivalence Requirements for Combination Drug Products Health Canada This notice serves to clarify that for all combination products requiring comparative bioavailability studies, the pharmacokinetic parameters to be reported and assessed are those which would normally be required of each drug if it were in the formulation as a single entity, as described in current TPD guidelines and policy statements. [DETAILS] Notice to Industry - Removal of Requirement for 15% Random Replicate Samples Health Canada This notice serves to remove the current requirement that fifteen percent of the subject samples be randomly selected and re-assayed when single assays are performed. [DETAILS] Official Methods Health Canada Conjugated Estrogens Determination of the Disintegration Time of Tablets Determination of Flame Projection Determination of Net Contents Thyroid [DETAILS] Product Life Cycle Health Canada As part of our mission to help Canadians maintain and improve their health, we evaluate and monitor the quality, efficacy and safety of biotechnology-based health products throughout their life cycle. [DETAILS] Quaternary Ammonium Hard Surface Disinfectant/Sanitizer Products Certification Health Canada The product named in this application will comply in all aspects with the requirements specified in the guideline, 'Standard Labels for Quaternary Ammonium Hard Surface Disinfectant Products'. [DETAILS] Regulatory Initiatives Health Canada The BGTD is committed to developing any new regulations, policies, and guidelines in consultation with stakeholders and interested parties. The links provided introduce the regulatory initiatives. [DETAILS] Report C: Report on Bioavailability of Oral Dosage Formulations, not in Modified Release Form, of Drugs Used for Systemic Effects, Having Complicated or Variable Pharmacokinetics Health Canada Earlier Reports (A and B) presented proposed guidelines for bioavailability testing and standards for bioequivalence of drugs with uncomplicated or non-variable pharmacokinetics, marketed as modified (Report B) or unmodified (Report A) formulations. This Report presents similar guidelines for "complicated" drugs marketed as unmodified formulations. [DETAILS] The Clinical Evaluation of Qt/Qtc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Health Canada This draft guidance provides recommendations to sponsors concerning the design, conduct, analysis and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization, an effect that can be measured as prolongation of the QT interval on the surface electrocardiogram. [DETAILS] The Clinical Evaluation of QT/QTc Interval Prolongation and proarrhythmic potential for non-antiarrythmic drugs Health Canada This document provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. [DETAILS] The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (S7B) Health Canada This guideline describes a nonclinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization. This guideline includes information concerning nonclinical assays and an integrated risk assessment. [DETAILS] Additional Donor Exclusion Measures to Address the Potential Risk of Transmission of variant Creutzfeldt-Jakob Disease (vCJD) through the Blood Supply Health Canada The purpose of this new Directive is to advise all Canadian blood establishments licenced to fabricate blood and blood components for transfusion of the requirement to implement further measures to reduce the potential risk of transmission of vCJD through the blood supply. [DETAILS] Biologics and Radiopharmaceuticals: Application/Submission Information > Policies Health Canada These policy documents are interpretations of the purpose and intent of the Food and Drugs Act and Regulations. These documents include draft policies out for consultation and final policies. [DETAILS] Blank Certified Product Information Document (Schedule D Drugs) (CPID (Schedule D Drugs)) Template in the CTD Format Health Canada The CPID (Schedule D drugs) template (or the appropriate parts of it) should be used with a drug submission in the CTD format for any biological product (described under Schedule D of the Canadian Food and Drugs Act and Regulations), or any combination drug for human use, which has a biological component. [DETAILS] Blood Establishment Licence Amendment Requirements for Information Technology Submissions Health Canada The purpose of this document is to provide guidance to facilities that collect blood and/or manufacture blood components (Blood Establishments) in the preparation of a Licence Amendment for Information Technology submissions. [DETAILS] Chemical Entity Products/Quality Health Canada These guidance documents are meant to provide assistance to industry and health care professionals on pharmaceutical quality. [DETAILS] Confidential DSL / NDSL Search Engine for Chemicals, Polymers, Organisms and Microorganisms Environment Canada Search for a specific confidential accession number on both the Domestic Substances List (DSL) and the Non-Domestic Substances List (NDSL). This search engine includes confidential accession numbers published in the Canada Gazette. [DETAILS] Directive 99-01: Donor Exclusion to Address Theoretical Risk of Transmission of Varient CJD through the Blood Supply Health Canada The purpose of this Directive is to advise all licenced Canadian blood establishments to take measures to reduce the theoretical risks of transmission of variant CJD (vCJD) through the blood supply by excluding from donating blood, all persons who have spent time in England, Scotland, Wales, Northern Ireland, Isle of Man and the Channel Islands amounting cumulatively to a period of 6 months or more between the years 1980 to 1996, inclusive. [DETAILS] Directive D2000-01: Donor Exclusion to Address Theoretical Risk of Transmission of Varient CJD Through the Blood Supply Health Canada The purpose of this Directive is to advise all licenced Canadian blood establishments which collect and manufacture blood and blood components to take measures to reduce the theoretical risks of transmission of variant Creutzfeldt-Jakob Disease (vCJD) through the blood supply by excluding from donating blood or blood components all persons who have spent time in France, exclusive of French territories outside the European continent, amounting, cumulatively, to a period of 6 months or more between the years 1980 to 1996, inclusive. [DETAILS] Directive: Implementation of Prestorage Leukoreduction of Cellular Blood Components Health Canada The purpose of this Directive is to advise all licensed Canadian blood establishments to take the necessary steps to implement prestorage leukoreduction of all allogeneic red blood cell and platelet components as soon as operationally feasible, but no later than June 30, 1999. [DETAILS] Donor Exclusion to Address Theoretical Risk of Transmission of variant Creutzfeldt-Jakob Disease (vCJD) through the Blood Supply Health Canada The purpose of this Directive is to advise all licenced Canadian blood establishments to take further measures to reduce the theoretical risks of transmission of vCJD through the blood supply. [DETAILS] Draft Guidance for Industry, Preparation of the Quality Information for Radiopharmaceuticals (Schedule C Drugs) using the Quality Information Summary-Radiopharmaceuticals (QIS-R) and Certified Product Information Document- Radiopharmceuticals (CPID-R) Templates Health Canada The purpose of this guideline is to provide sponsors of New Drug Submissions (NDSs) and related submissions (responses to information requests during the review, Responses to Notices of Deficiency or Non-Compliance (NODs/NONs), Supplemental New Drug Submissions (SNDSs), and Notifiable Changes (NCs) including Clinical Trial Applications (CTA) with approaches that acceptably meet the regulatory requirements that apply to the "Quality" (chemistry and manufacturing) portions of submissions. [DETAILS] Draft Help Notes for Completing the Quality Information Summary-Biologicals (QIS-B) and Certified Product Information Document- Biologicals (CPID-B) Templates Health Canada These draft help notes were written to provide some assistance to sponsors while completing the draft Quality Information Summary- Biologicals (QIS-B) and Certified Product Information Document- Biologicals (CPID-B) electronic templates, as part of preparing their drug submission. An official Biologics and Genetic Therapies Directorate (BGTD) Guidance Document will be available for the final version of the templates. [DETAILS] Drug Product Database (DPD) Health Canada Search active products and discontinued products. [DETAILS] DSL / NDSL Search Engine for Chemicals and Polymers Environment Canada Search for a specific CAS Registry number on both the Domestic Substances List (DSL) and the Non-Domestic Substances List (NDSL). This search engine includes CAS Registry numbers published in the Canada Gazette. [DETAILS] DSL / NDSL Search Engine for Enzymes, Organisms and Microorganisms Environment Canada Search for a specific Enzyme Number or Micro-organisms Number on both the Domestic Substances List (DSL) and the Non-Domestic Substances List (NDSL). [DETAILS] Guidance for Industry: Measures to Prevent West Nile Virus Transmission Through Cells, Tissues and Organs for Transplantation and Assisted Reproduction Health Canada This is to inform you that Health Canada has released a Guidance Document entitled “Measures to Prevent West Nile Virus Transmission Through Cells, Tissues and Organs for Transplantation and Assisted Reproduction”. [DETAILS] Guidance for Industry: Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotechnological/ Biological (Biotech) Products Health Canada This document is intended to provide additional guidance to industry, for the preparation of the quality information for Drug Submissions, structured using the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format. [DETAILS] Guidance for Industry: Preparation of the Quality Information for Drug Submissions in the CTD Format: Blood Products Health Canada This document is intended to provide additional guidance to industry, for the preparation of the quality information for Drug Submissions, structured using the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format. [DETAILS] Guidance for Industry: Preparation of the Quality Information for Drug Submissions in the CTD Format: Conventional Biotherapeutic Products Health Canada This document is intended to provide additional guidance to industry, for the preparation of the quality information for Drug Submissions, structured using the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format. [DETAILS] Guidance for Industry: Preparation of the Quality Information for Drug Submissions in the CTD Format: Vaccines Health Canada This document is intended to provide additional guidance to industry, for the preparation of the quality information for Drug Submissions, structured using the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format. [DETAILS] Guidance for Industry: Stability Testing of Existing Drug Substances and Products Health Canada This guidance addresses the stability information to be included on existing drug substances and associated drug products in new drug submissions (NDSs) and abbreviated new drug submissions (ANDSs), Supplements and Notifiable Changes. [DETAILS] Guidance for Sponsors: Regulatory Requirements for Intravenous Immunoglobulin (IVIG) Products in Canada Health Canada Purpose: To provide guidance to sponsors of Intravenous Immunoglobulin products on the regulatory requirements, particularly minimum clinical data requirements for submissions involving approved and non-approved Intravenous Immunoglobulin products. [DETAILS] Guidance on the Manufacture of Human Plasma-Derived Products, Viral Safety Evaluation Health Canada The focus of this document is to discuss those processes and procedures, used in the manufacture of products derived from human plasma, in the context of their contribution to safety. [DETAILS] Interim Process Guidelines for Reporting Changes and Incidents Occurring in Operational Computerised Blood Systems Health Canada The objectives of these Guidelines are to describe the types of changes and incidents to be reported to the BGTD, Blood Establishment Regulation Division (BERD) of Health Canada, and to standardize the reporting process. [DETAILS] Living Modified Organisms Regulations Environment Canada The Living Modified Organisms Regulations will allow Canada to implement the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Protocol). The Protocol provides a framework for the assessment and management of the risks to the conservation and sustainable use of biodiversity from the transboundary movement of living modified organisms. [DETAILS] Lot Release Program for Schedule D (Biologic) Drugs Health Canada The purpose of this document is to outline the Lot Release Program for Schedule D (biologic) drugs and the extent of the review and testing of biologic drugs prior to their release for sale in Canada by the Biologics and Genetic Therapies Directorate (BGTD). [DETAILS] Masked Name Regulations Department of Justice Canada Regulations respecting the masking of names of substances to prevent the disclosure of confidential information. [DETAILS] New Substances Assessment and Control Bureau Health Canada The New Substances Assessment and Control Bureau (NSACB) is responsible for the pre-manufacture or pre-import assessment of the potential health risks to the general population associated with new chemical substances such as fabric dyes and fuel additives, as well as products of biotechnology such as micro-organisms used in reclaiming land after an oil spill. [DETAILS] New Substances Notification Branch - Contact Us Environment Canada If you have technical questions or require additional information on procedures for New Substances Notifications, please contact the New Substances Notification Infoline or Regional officers. [DETAILS] New Substances Notification Regulations (Chemicals and Polymers) (Proposed Regulations) Government of Canada The proposed Regulations are part of a new regulatory structure that divides the NSNR into two distinct Regulations: 1. New Substances Notification Regulations (Chemicals and Polymers), which will apply to chemicals (including biochemicals) and polymers (including biopolymers) that are for a use not covered under other federal legislation listed in Schedule 2 of the Act; and 2. New Substances Notification Regulations (Organisms), which will apply to living organisms that are for a use not covered under other federal legislation listed in Schedule 4 of the Act. These regulations are expected to come into force in early 2005. [DETAILS] New Substances Program Homepage Environment Canada Provides information on the New Substances Program under the authority of the Canadian Environmental Protection Act, 1999 (CEPA 1999) and jointly administered by Environment Canada and Health Canada. [DETAILS] Notice of Compliance Listings Health Canada A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. [DETAILS] Notice: Revised Quality Guidances on the Implementation of the Common Technical Document for Biological Products Health Canada The Biologics and Genetic Therapies Directorate (BGTD) is pleased to announce the release of the following updated guidance documents and electronic summary template on the use of the International Conference on Harmonisation (ICH) Common Technical Document (CTD) format for preparing the Quality information, in support of a drug submission for a biological (Schedule D) product for human use, filed in Canada pursuant to Part C of the Food and Drug Regulations- Divisions 1, 1A, 2, 4, 5, and/or 8. [DETAILS] Sample Template with Examples and Specific Notes Regarding the Preparation of the Comprehensive Summary (Chemistry and Manufacturing) for Biological Products of Recombinant DNA Origin (CS(CM-rDNA)) Health Canada Notes and examples are provided in the following sample CS(CMrDNA) which illustrate the nature and extent of information which should be reported. [DETAILS] Stereochemical Issues in Chiral Drug Development Health Canada This document is intended to provide sponsors of New Drug Submissions (NDS's) and Abbreviated New Drug Submissions (ANDS's) with guidance on issues specific to chiral pharmaceuticals that should be addressed during drug development. [DETAILS] Therapeutic Products Programme (TPP) Responses to Good Manufacturing Practices (GMP) - Questions from Industry Health Canada Responses to Good Manufacturing Practices (GMP) - Questions from Industry.  The responses to the questions submitted and addressed in this document are based on current information, procedures, and policies which are in place at this time. [DETAILS] DATE MODIFIED:  2006-10-25 Important Notices