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Draft Guidelines Out for Comment

The following material originates with an organization not subject to the Official Languages Act and is available on this site in the language in which it was written.

Le texte suivant provient d'un organisme qui n'est pas assujetti à la Loi sur les langues officielles et il est mis à la disposition du public dans la langue d'origine.

arrow E15 Draft (Step 2) ICH Guidance: Pharmacogenomics
Date: 2006-11-20

arrow Q4B Draft (Step 2) ICH Guidance : Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC)
Date: 2006-07-21

  Q4B Draft (Step 2) ICH Guidance: Annex 1 Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC) on Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)
Date: 2006-07-21

arrow Q9 Draft (Step 2) ICH Guidance : Quality Risk Management
Date: 2005-08-30

arrow E2B(M) Draft (Step 2) Guidance : Second Revision of the ICH Guidance on Clinical Safety Data Management: Data Elements for Transmisson of Individual Case Safety Reports
Date: 2005-06-13

arrow M5 Draft (Step 2) ICH Guidance : Data Elements and Standards for Drug Dictionaries
Date: 2005-06-13

 
 
arrow Q8 Draft (Step 2) ICH Guidance: Pharmaceutical Development
Date: 2005-03-08

arrow S8 Draft (Step 2) ICH Guidance: Immunotoxicology Studies in Human Pharmaceuticals
Date: 2005-03-08

arrow Q5E Draft (Step 2) ICH Guidance: Comparability of Biotechnological / Biological Products Subject to Changes in Their Manufacturing Process
Date: 2004-01-06

arrow E2E Draft (Step 2) ICH Guidance: Pharmacovigilance Planning
Date: 2003-12-03

arrow E2D Draft (Step 2) ICH Guidance: Post Approval Safety Data Management: Definitions and Standards for Expediting Reporting
Date: 2003-09-16

arrow CTD-Quality Draft (Step 2) ICH Guidance: Questions and Answers
Date: 2002-10-31

arrow Draft (Step 2) ICH Guidance: Addendum to E2C: Periodic Safety Update Reports for Marketed Drugs V1
Date: 2002-10-31

arrow ICH Guideline E10: Choice of Control Groups in Clinical Trials (Step 2)
Date: 1999-05-07

arrow MedDRA Term Selection: Points to Consider
Date: 2000-08-01

Last Updated: 2006-11-20 Top