Strategic Plan April 2004 - March 2007
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Table of Contents
Introduction
Organizational Profile
and History
Health Canada's
Mandate
Health Products
and Food Branch's (HPFB) Mandate
Veterinary Drugs
Directorate's (VDD) Mandate
Our Vision
Guiding Principles
Core Activities
Key Result Areas
Timely Review of
Submissions
Policy & Regulatory
Development
International Cooperation
/ Harmonization
Public Involvement
and Outreach
Effective and Responsible
Management of Human and Financial Resources
Introduction
The Veterinary Drugs Directorate's (VDD) Extended Management
Committee met for their first retreat in October 2002 during which they
established VDD's strategic direction for the next three fiscal
years.1
This meeting set the foundation for development of the 2003-2006 Strategic
Plan, which underwent a rigorous process of revision and refinement
prior to its approval on September 8, 2003. In keeping with VDD's
commitment to transparency, the 2003-2006 Strategic Plan was subsequently
posted on the VDD Web site.
The VDD Extended Management Committee met again in November 2003 with
the purpose to review, validate and revise the 2003-2006 Strategic Plan.
The discussions held at this meeting were used to update the Strategic
Plan for the fiscal years 2004-2007, and to ensure that VDD continues
to be properly aligned with Government, Department, Branch and stakeholder
priorities in order to achieve its strategic objectives.
The process used to update the Strategic Plan for fiscal years 2004-2007
employed an extensive environmental scan to identify forces and influences
that may affect the work of the Directorate over the coming years. The
Extended Management Committee then set about to determine if the Key
Result Areas (KRAs) were still appropriate, given the factors
and influences that may be facing the Directorate. The revised Key
Result Areas for VDD include (in no particular order): Effective
and Responsible Management of Human & Financial Resources, International
Cooperation/Harmonization, Public Involvement and Outreach, Policy &
Regulatory Development and Timely Review of Submissions.
For each Key Result Area, managers were asked
to review, validate and revise the strategic objectives along with the
specific strategies required to achieve them. This was done taking into
account progress made in the previous fiscal year, bearing in mind the
factors and influences that may affect program delivery in the short
and long term future.
This document outlines the strategic direction of the Veterinary Drugs
Directorate for the fiscal years 2004-2007. It serves as a guide to
aid the Directorate in setting appropriate priorities in order to achieve
its strategic objectives. This Strategic Plan was approved by the Extended
Management Committee on March 29, 2004.
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Organizational Profile and History
The Veterinary Drugs Directorate was created in October 2001. It is
one of several Directorates in the Health Products and Food Branch (HPFB)
that reports to the Assistant Deputy Minister, HPFB. The mandate of
VDD flows from the mandate of HPFB, and ultimately from the mandate
of Health Canada.
Health Canada's Mandate
To help the people of Canada maintain and improve their health.
Health Products and Food Branch's (HPFB) Mandate
HPFB's mandate is to take an integrated approach to the management
of the risks and benefits to health related to health products and food
by:
- minimizing health risk factors to Canadians while maximizing the
safety provided by the regulatory system for health products and food;
and,
- promoting conditions that enable Canadians to make healthy choices
and providing information so that they can make informed decisions
about their health.
Veterinary Drugs Directorate's (VDD) Mandate2
VDD is responsible for ensuring the safety of foods such as milk, meat,
eggs, fish, and honey from animals treated with veterinary drugs. We
also ensure that veterinary drugs sold in Canada are safe and effective
for animals. Through this dual mandate, VDD contributes to the well-being
of Canadians.
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Our Vision
VDD's vision is to be recognized nationally and internationally
as an organization that embraces good science through teamwork based
on leadership and mutual respect. VDD will also be recognized for its
excellence in science-based decision making.
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Guiding Principles
To guide the Veterinary Drugs Directorate towards its vision, and in
keeping with the core principles of the Government of Canada3,
VDD has adopted the following Guiding Principles:
- Transparency
- Accountability
- Financial Responsibility
- Ethical Conduct
Consideration of the four guiding principles above will be applied
to all decisions and actions of the Veterinary Drugs Directorate. This
will ensure sound decision making, and make certain that the best interests
of Canadians are met in fulfilling VDD's mandate.
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Core Activities
In fulfilling its mandate, VDD conducts a number of Core
Activities (CA).
Scientific Activities
CA 1 - Review of Industry Submissions including:
- New Drug Submissions (NDS)
- Supplemental New Drug Submissions (S/NDS)
- Abbreviated New Drug Submissions (ABNDS)
- DIN applications (DIN)
- Preclinical New Drug Submissions (also known as IND submission)
- Experimental Studies Certificates (ESC)
- Emergency Drug Sales (also know as EDR)
- Protocol Review (PR) and Notifiable Changes (NC)
CA 2 - Establishment of Maximum Residue Limits (MRLs) and Administrative
Maximum Residue Limits (AMRLs) for veterinary drugs in foods
CA 3 - Pharmacovigilance
CA 4 - Enforcement and Compliance Related Activities - Including: Health
Risk Assessments (HRAs)
CA 5 - Research and Surveillance
CA 6 - Policy and Regulatory Development
Operational and Support Activities
CA 7 - Issues Management - Including: briefing notes, question period
notes and advice to staff and partners
CA 8 - Management - Including: performance measurement
CA 9 - Process Support - Including: electronic review of submissions
and external charging
CA 10 - Planning and Reporting
CA 11 - Public Involvement and Outreach
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Key Result Areas
To optimize delivery of its mandate, VDD has identified the following
Key Result Areas (in no particular order) :
- Timely Review of Drug Submissions
- Policy & Regulatory Development
- International Cooperation / Harmonization
- Public Involvement and Outreach
- Effective and Responsible Management of Human & Financial Resources
These Key Result Areas can effectively be related back to each scientific
core activity. By applying the KRAs in this manner, VDD is able to conduct
programs and activities according to its strategic plan. Strategic objectives
related to each of the Key Result Areas as well as the specific strategies
required to achieve them are elaborated below.
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Timely Review of Submissions
Under the Canadian Food and Drugs Act and Regulations, manufacturers
who wish to sell veterinary drugs in Canada must receive approval from
Health Canada's Veterinary Drugs Directorate. The Directorate
also establishes Maximum Residue Limits (MRLs and AMRLs) for veterinary
drugs used in food-producing animals. Manufacturers submit data to demonstrate/establish
the safety of any residues in food from treated animals, as well as
the safety and efficacy of the products for the treated animals.
To ensure timely access to safe and effective veterinary drugs, VDD
needs to optimize every aspect of the evaluation and approval process.
Impact on Canadians
The timely review of submissions contributes to the health of Canadians
by ensuring greater availability of drugs that when used in food-producing
animals, are safe for humans consuming foods derived from treated animals.
This will ensure more high quality and affordable food products. Timely
access to safe and effective veterinary drugs for food-producing and
companion animals will enable innovation, facilitate trade, increase
investment, and contribute to building a 21st century Canadian
economy.
Strategic Objectives:
1.1. Increase VDD's capacity by augmenting expertise and knowledge
in emerging science areas.
Strategies:
1.1.1 Implement the Learning & Development Framework
to provide employees with opportunities to improve their knowledge as
well as their ability to work in teams and in partnerships. This includes
offering regular scientific seminar opportunities for VDD staff.
1.1.2 Develop a succession plan and a staffing plan.
This will allow VDD to better match the knowledge and expertise of candidates
with the Directorate's requirements for scientific and managerial
knowledge and competencies.
1.2. Develop policies and processes which will facilitate the submission
review process. Clear, explicit and documented policies, guidance documents
and Standard Operating Procedures (SOPs) will allow for effective and
efficient actions by all employees and greater compliance and understanding
by external stakeholders. Once implemented, policies and guidelines
will improve the efficiency and effectiveness in the review divisions
by, for example, improving the quality of incoming files and allowing
for rejection of inadequate submissions at the initial screening process.
Strategies:
1.2.1
- Coordinate and develop policies, regulations,
guidance documents, guidelines and SOPs across VDD to ensure consistency,
and align those being developed with other directorates, branches, and
departments. (This strategy requires VDD to collaborate and consult
with partners and stakeholders.)
- Establish an ongoing cycle of gap analysis in order to continuously
focus the efforts of VDD on priority issues.
1.2.2 Apply enabling tools to facilitate review of submissions
and improve timeliness (e.g., electronic submission reviews).
1.3. Increase international cooperation for harmonization of the technical
requirements for registration of veterinary drugs and standards. The
result will allow VDD to draw upon international expertise in order
to assist, strengthen and expedite Canada's review process and
standards setting activities.
Strategies:
1.3.1 Reassess our achievable level of participation
in international organizations, taking into account our capacity, financial
resources and progress made to date.
1.3.2 Implement an internal system that will track key
participants, resource requirements, expected outcomes and performance
indicators, to be used to evaluate each participation.
1.3.3 Enhance our bilateral relationship with the United
States Food and Drug Administration (FDA) Center for Veterinary Medicine
(CVM) and other jurisdictions.
1.4. Develop performance indicators for submission reviews.
Strategies:
Establish standards for submission review (included
in the Management core activity, CA-8).
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Policy & Regulatory Development
Policy & regulatory development facilitates the implementation
of the Directorate's strategic direction. Science-based policies
directly contribute to protecting the health of Canadians by guiding
decision making related to issues such as Antimicrobial Resistance and
Extra-Label Drug Use (ELDU). Operational policies help VDD to harmonize
procedures and support quality control.
Evidence-based decision making and policy analysis is fundamental in
developing appropriate regulatory and non-regulatory mechanisms to protect
and promote the health of Canadians. Regulatory development is undertaken
using a Smart Regulations4
approach, which emphasizes appropriate instrument choice in order to
protect Canadians, the public interest and enable innovation. Use of
the Smart Regulations approach is exemplified through the adoption of
Administrative Maximum Residue Limits (AMRLs), which have facilitated
producers' ability to comply with, and regulatory agency's
enforcement of residue limits for veterinary drugs in food, without
having to wait for regulations to be promulgated.
Impact on Canadians
Policy and regulatory development within VDD is undertaken using evidence-based
decision making and a Smart Regulations approach, which contributes
to the Directorate's capacity for risk management. Policies that are
explicit and transparent contribute to the health and safety of Canadians
by ensuring that regulatory and risk-management decisions are made consistently.
VDD also undertakes frequent policy and regulatory gap analyses to focus
the efforts of the Directorate on priority issues, which helps foster
a flexible organization with the capacity to fulfil its mandate and
priorities in a changing environment.
Strategic Objectives:
2.1 The overall objective is to develop and implement policies, regulations,
guidance documents, guidelines and SOPs to support all of VDD's
core activities5 .
Strategies:
2.1.1
- Coordinate and develop policies, regulations,
guidance documents, guidelines and SOPs across VDD to ensure consistency,
and align those being developed with other directorates, branches, and
departments. (This strategy requires VDD to collaborate and consult
with stakeholders.)
- Establish an ongoing cycle of gap analysis in order to continuously
focus the efforts of VDD on priority issues.
2.2 Legislative Renewal affords the opportunity to examine the legislative
and regulatory basis of existing policies and regulations, to assess
and promote possible changes.
Strategies:
2.2.1 Review of current policies and regulations.
2.2.2 Identify constraints of current regulations.
2.2.3 Gap analysis in consultation with partners and
stakeholders.
2.2.4 Develop and implement policy priorities.
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International Cooperation / Harmonization
Achieving harmonization is important for public health reasons (e.g.,
ensuring quality of imports and domestic products through high standards)
and for business (e.g., ensuring a level playing field in the global
marketplace). To enhance harmonization with other jurisdictions, the
Veterinary Drugs Directorate is an 'observer' in the Veterinary
International Cooperation on Harmonization of Technical Requirements
for the Registration of Veterinary Medical Products (VICH)6. Involvement
in the VICH harmonization process allows VDD to participate on behalf
of the Government of Canada in the VICH Steering Committee, as well
as a number of technical working groups. Working together with partners
such as the Canadian Food Inspection Agency (CFIA, also representing
the Government of Canada on VICH) and the Canadian Animal Health Institute
(CAHI, representing Canadian veterinary drug manufacturers on VICH),
enables Canada to have guidelines for data requirements that are harmonized
with other countries.
VDD also represents the government of Canada on the Codex Committee
on Residues of Veterinary Drugs in Food (CCRVDF). CCRVDF works to develop
international standards pertaining to residues of veterinary drugs in
foods, such as maximum residue limits.
Impact on Canadians
International cooperation will increase the level of harmonization
between VDD and equivalent organizations in other jurisdictions. VDD's
participation in global standard-setting initiatives ensures that Canada's
views and priorities are taken into consideration when harmonizing technical
requirements internationally. Participation in such international activities
also contributes to the federal government's goal of ensuring
Canada's role in the world as one of pride and influence in order
to advance Canadian values and promote Canada's independent voice
abroad.
Strategic Objectives:
3.1 VDD to actively participate in international activities to achieve
its key business objectives.
Strategies:
3.1.1 Reassess our achievable level of participation
in international initiatives, taking into account our capacity, financial
resources and progress made to date.
3.1.2 Implement an internal system that will track key
participants, the resource requirements, expected outcomes and performance
indicators, to be used to evaluate each participation.
3.1.3 Enhance our bilateral relationship with the United
States Food and Drug Administration Center for Veterinary Medicine and
other jurisdictions.
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Public Involvement and Outreach
Since its establishment as a Directorate in 2001, VDD has worked intensively
to develop linkages that contribute to enhanced partnerships and continuous
exchange of information with stakeholders. With public health issues
becoming increasingly more complex and the public requesting a more
direct role in policy and program development, VDD has set up a series
of programs and activities to ensure that stakeholders are adequately
consulted throughout our decision making process.
VDD's Stakeholder Committee, established in September 2002, is
comprised of representatives from a broad spectrum of interests including
other federal government partners (e.g., CFIA), other levels of government
(e.g., provincial/territorial), industry, veterinarians, academia, producers,
consumers, animal welfare and environmental groups. The Stakeholder
Committee meets regularly, allowing VDD to involve stakeholders in our
decision making in accordance with Health Canada's Decision Making
Framework.
VDD recognizes the importance of establishing linkages with federal,
provincial and territorial governments. VDD consults regularly with
provinces and territories on various issues through special consultations
(e.g. on AMR), the F/P/T Committee on Food Safety Policy and Agri-Food
Inspection Committee, as well as through the Canadian Food Inspection
System Implementation Group.
Impact on Canadians
Maintaining an open, transparent, leading-edge and proactive organization
will support VDD in its efforts to satisfy the varied needs of our stakeholders,
and will contribute to enhanced public trust and confidence in the Canadian
food system.
Strategic Objectives:
4.1 Maintain an open, transparent, leading-edge and proactive organization
by ensuring that effective outreach and public involvement mechanisms
are in place, which will enable its stakeholders/partners and the public
to understand and contribute to VDD's programs, priorities, capacity
and performance.
Strategies:
4.1.1 Ensure proper instrument choice for public involvement
mechanisms by following the criteria and methodologies outlined in VDD's
and Health Canada's Public Involvement policies.
4.2 Ensure development and use of work plans and conduct
of performance reviews to assess the quality of our work, in order to
continuously accomplish the goals of the organization and adapt to new
requirements in terms of time and science.
Strategies:
4.2.1 Participate in and make presentations at national,
provincial and professional events.
4.2.2 Develop educational materials about VDD and veterinary
drugs issues related to public health.
4.2.3 Conduct Web consultations to obtain feedback from
the public and stakeholders.
4.2.4 Maintain and update the VDD Web site as an effective
tool to increase transparency and inform the public and stakeholders
of emerging health issues.
4.3 Consult directly with the public throughout VDD's priority
setting, decision making, policy and regulatory development process
to ensure that issues and concerns are understood and addressed accordingly.
Strategies:
4.3.1 Consult with VDD's Stakeholder Committee
on programs and priorities, as well as set up and maintain steering
and advisory expert committees on important issues such as AMR and ELDU.
4.3.2 Consult with VDD stakeholders on proposed amendments
to the Food and Drug Regulations, such as the establishment of Maximum
Residue Limits.
4.3.3 Develop public involvement plans to consult appropriately
with the public and stakeholders on VDD policy development such as AMR,
Unapproved Drugs, Natural Health Products, etc.
4.4 Partner with internal and external stakeholders on decision making
regarding national and cross-jurisdictional issues by seeking and receiving
advice and innovative solutions.
Strategies:
4.4.1 Maintain partnerships with other government departments,
agencies, branches and directorates to jointly address ongoing and emerging
public health issues.
4.4.2 Partner with key external stakeholder groups
on specific issues as appropriate.
4.5 VDD to improve the efficiency and effectiveness of public involvement
activities.
Strategies:
4.5.1 Reassess our achievable level of participation
in national events and public involvement activities, taking into account
our capacity, financial resources and progress made to date.
4.5.2 Implement an internal system that will track
key participants, the resource requirements, expected outcomes and performance
indicators, to be used to evaluate each participation.
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Effective and Responsible Management of Human and
Financial Resources
The Veterinary Drugs Directorate's dual mandate to ensure the safety
of food from animals treated with veterinary drugs, and to ensure that
veterinary drugs sold in Canada are safe and effective for animals,
embodies a level of complexity that exists in few other organizations.
As a result, VDD's staff must possess the requisite level of competencies,
skills and abilities. VDD recognizes the value these skills and competencies
add to the organization, and is committed to lifelong learning for its
management and staff.
The guiding principles of the Veterinary Drugs Directorate are particularly
relevant to the effective and responsible management of financial resources.
VDD is committed to transparency, accountability, financial responsibility
and ethical conduct with regard to fiscal management. This is exemplified
in VDD's use of work plans and resource allocation tools to ensure accountability
and make the best use of available resources.
Impact on Canadians
The strategies above will ensure that VDD operations are streamlined
and accountable, resulting in maximum benefits for the resources expended.
They will result in a professional and flexible organization, that has
the capacity to fulfil its mandate and priorities in a changing environment.
Strategic Objectives:
5.1 Maintain an organization that embraces good science and best management
practices through teamwork based on leadership and mutual respect.
This organization is comprised of a sufficient number of highly qualified,
competent and motivated employees who acknowledge their roles and responsibilities
and serve as ambassadors of the Directorate. Conditions conducive to
a respectful, healthy and vibrant workplace are critical in achieving
this objective.
Strategies:
5.1.1 Implement the Learning and Development Framework
and the Orientation Package to provide employees with opportunities
to improve their knowledge as well as their ability to work in teams
and in partnerships. This includes offering regular scientific seminar
opportunities for VDD staff.
5.1.2 Apply the Performance Discussion Process (PDP)
Framework (e.g. related to employee appraisal) to assess the quality
of our work, in order to continuously accomplish the goals of the organization
and adapt to new requirements in terms of time management and scientific
advancement.
5.1.3 Develop succession and staffing plans. These will
allow VDD to better match the knowledge and expertise of candidates
with the Directorate's requirements for scientific and managerial knowledge
and competency.
5.1.4 Continuously improve internal communication mechanisms
so that they strategically address the quality and the quantity of information.
5.2 Ensure sound financial management.
5.2.1 Ensure the development and use of Divisional/Directorate
work plans and resource allocation tools.
5.2.2 Implement a modern financial management system.
5.3 Develop/Adapt and implement an accountability framework suitable
for VDD.
5.3.1 Develop and implement program performance indicators
to assess the quality of our work and achievement of fiscal goals/objectives,
and to adapt to new requirements and priorities.
5.3.2 Build a Quality Management System which encompasses
Values and Ethics. (Included in CA 8)
5.3.3 Ensure the use of modern comptrollership practices.
1. The fiscal year for the Veterinary Drugs Directorate extends from April 1 to March 31.
2. The wording of the VDD's mandate is currently under review.
3. Documented in the press release: "Prime Minister Announces
Appointment of Cabinet", December 12, 2003.
4. Smart Regulations is a government-wide approach to regulatory
reform that has both protecting and enabling characteristics with the
goal of promoting health, safety and sustainability, contributing to
economic growth and reducing burden on business.
5. All policies are to be based on Health Canada's Decision
Making Framework, and fit within the context of Health Canada's science-based
approach to decision making to support its regulatory framework.
6. Launched in 1996, VICH is a trilateral (EU-Japan-USA) program
aimed at harmonizing technical requirements for veterinary product registration.
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