Subject matters | Details | Categories |
---|---|---|
Health, Industry
|
Discussions with ISED towards a national strategy for the biomanufacturing and the life sciences sector.
|
Policies or Program
|
Health
|
Health Canada regarding the development of a national pharmacare strategy.
|
Policies or Program
|
Health, Industry
|
Health Canada with respect to its Regulatory Systems Review for Therapeutic Products.
|
Regulation, Policies or Program
|
Health, Industry
|
Health Canada with respect to the process for the approval and renewal of foreign sites for Drug Establishment License (DEL) holders. Related guidance documents include the Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080), the Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002) and the Guidance on Good Manufacturing Practices for Active Pharmaceutical Ingredients (GUI-0104).
|
Policies or Program
|
Health, Industry
|
Health Canada with respect to user fees for therapeutic product regulatory programs.
|
Policies or Program, Legislative Proposal, Bill or Resolution, Regulation
|
Industry
|
Innovation, Science and Economic Development Canada (ISED) Innovation Agenda regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation.
|
Policies or Program
|
Health, Industry, International Trade
|
Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council.
|
Policies or Program, Regulation
|
Health, Industry
|
Participation in Competition Bureau consultations with respect to pharmaceuticals.
|
Policies or Program
|
Health
|
Proposals related to Health Canada's Identical Medicinal Ingredient Policy.
|
Policies or Program
|
Health
|
Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions.
|
Policies or Program
|
Health, Industry
|
Provide input into policy discussions with respect to the implementation of a national pharmacare program.
|
Legislative Proposal, Bill or Resolution
|
Health, Industry, International Trade
|
Provide input into the Canada-United States-Mexico Agreement (CUSMA).
|
Legislative Proposal, Bill or Resolution
|
Health, Industry, Internal Trade, International Relations, International Trade, Taxation and Finance
|
Provide input into the Canada-US trade relationship as it pertains to medicines, including the impact of tariffs on medicines and medicine manufacturing inputs for the Canadian healthcare system, patients and industry.
|
Policies or Program
|
Industry, International Trade
|
Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property.
|
Legislative Proposal, Bill or Resolution
|
Health, Industry
|
Provide input into the modernization of the Food and Drugs Act and related Regulations, Guidelines and Policies as they pertain to pharmaceuticals.
|
Regulation, Policies or Program, Legislative Proposal, Bill or Resolution
|
Industry
|
Provide input into the Patented Medicine Prices Review Board (PMPRB) consultations regarding its Policies, Guidelines and Procedures.
|
Policies or Program
|
Health, Industry
|
Providing input with respect to the approval pathway for biosimilar medicines by Health Canada.
|
Policies or Program
|
Health, Industry
|
Seeking harmonization of regulatory regimes and administrative processes nationally and internationally.
|
Policies or Program
|
Health, International Trade
|
To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat substandard and falsified medicines in Canada and around the world.
|
Policies or Program
|
The Canadian Generic Pharmaceutical Association's mission is to promote an environment which supports and enhances the provision of affordable generic and biosimilar medicines to Canadians and patients around the world through research, development and manufacturing of pharmaceuticals and fine chemicals in Canada. Through its Biosimilars Canada division, it provides leadership in educating Canadian stakeholders about biosimilar medicines, and advocating for policies that support their approval, reimbursement and market acceptance.
JAMES KEON, PRESIDENT
Address:
501 - 4100 Yonge Street
Toronto, ON M2P 2B5
Canada
Telephone number:
416-223-2333
Fax number:
416-223-2425