L'Association canadienne du médicament générique (ACMG) / Canadian Generic Pharmaceutical Association (CGPA)
Enregistrement :
39
de
54
(2015-06-19
à
2015-11-15)
Politique ou Programme
Health Canada regarding the need for effective implementation of the National Pharmaceuticals Strategy by federal and provincial governments.
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).
Industry Canada's Science and Technology strategy regarding the need for a balanced intellectual property regime and the important role competition plays in encouraging innovation.
Participation in Competition Bureau consultations respect to intellectual property enforcement.
Patented Medicine Prices Review Board (PMPRB) regarding claims of jurisdiction with respect to generic drug products associated with a patent.
Proposals related to Health Canada's Identical Medicinal Ingredient Policy.
Proposals to enhance transparency of the Health Canada Reconsiderations Policy for drug submissions.
Providing input into the development and implementation of an approval pathway for Subsequent Entry Biologics (SEBs) by Health Canada.
To encourage the Government of Canada to continue to participate in truly international discussions with respect to effective measures to combat counterfeit pharmaceuticals in Canada and around the world.
Politique ou Programme, Règlement
Participate in Government of Canada consultations with respect to the Beyond the Border Working Group.
Participate in Government of Canada consultations with respect to the Regulatory Cooperation Council.
Participation in consultations and providing input into Health Canada consultations on tamper resistance policy for pharmaceuticals.
Proposition législative, Projet de loi ou résolution
Provide input into policy discussions with respect to the potential development of a national pharmacare program.
Provide input into the Government of Canada's negotiations regarding the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) with respect to pharmaceuticals, counterfeit medicines, border measures and intellectual property.
Provide input into the Government of Canada's negotiations regarding the Canada-India Comprehensive Economic Partnership Agreement (CEPA) as they pertain to the pharmaceutical industry.
Provide input into the Government of Canada's negotiations regarding the Canada-Japan Economic Partnership Agreement (EPA) as they pertain to the pharmaceutical industry.
Provide input into the Government of Canada's negotiations regarding trade negotiations with respect to pharmaceuticals, counterfeit medicines, and intellectual property.
Provide input into the Government of Canada's negotiations with respect to the Trans Pacific Partnership (TPP) as they pertain to pharmaceuticals, counterfeit medicines, border measures and intellectual property.
Proposition législative, Projet de loi ou résolution, Règlement
Participation in consultations and providing input into the modernization of the Food and Drugs Act and related Regulations with respect to pharmaceuticals.
The need for amendments to the Patented Medicines (Notice of Compliance) Regulations of the Patent Act and address operational concerns: bring finality to proceedings under the Regulations, allow generic manufacturers to amend a Notice of Allegation (NOA), and provide meaningful damages and other disincentives to discourage abuse of the Regulations by brand-name companies.