Drug and health products international activities
Health Canada has a long history of cooperation with international counterparts and organizations. Our engagements have taken many forms ranging from informal information exchanges to multilateral harmonization initiatives.
We are involved internationally as a means of actively:
- Leveraging resources and knowledge,
- Ensuring application of sound regulatory practices and standards which are consistent, whenever possible, with international norms,
- Strengthening and facilitating existing mutual cooperation with international jurisdictions in scientific and regulatory areas,
- Addressing the challenges of globalization, new technologies and timely approval of new medicines, and,
- Reducing risks associated with therapeutic products marketed in Canada.
Strong relations and dialogue with international counterparts are also important in achieving program objectives in an increasingly complex regulatory world.
What information can you find here
International Generic Drug Regulators Pilot (IGDRP)
Description of the IGDRP
The IGDRP was formed in 2012 as a three year pilot to implement measures that would enhance the efficiency of the review process, strengthen global regulatory oversight and promote the adoption of modern science and risk based approaches on the part of both industry and agencies.
Details on IGDRP objectives and activities may be found in the World Health Organization (WHO) Drug Information article of April, 2014.
Information Sharing Pilot using the European Union's Decentralised Procedure
- Notice - Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Decentralised Procedure (DCP) of the European Union
- Form - Expression of Interest (EOI) Request to Participate in the First Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Decentralised Procedure of the European Union
Information Sharing Pilot using the European Union's Centralised Procedure
The information sharing pilot has now expanded to include applications filed under European Medicines Agency's (EMA) Centralised Procedure (CP).
Please find attached below the EOI Notice, the EOI form, the Summary of Quality Differences form and a Consent Form to share regulatory information on the restricted part of the Active Substance Master File (ASMF). On February 4, 2015 TPD invited Canadian manufacturers to submit an Expression of Interest (EOI). Please submit any comments or questions to the following address: TPD-DPT.International@hc-sc.gc.ca.
- Notice - Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Centralised Procedure (CP) of the European Union
- Form - Expression of Interest (EOI) Request to Participate in the Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Centralised Procedure of the European Union
- Consent Form to share regulatory information on the restricted part of the Active Substance Master File (ASMF) in the Information Sharing Pilot for the Evaluation of Generic Drug Applications involving the Centralised Procedure of the European Union.
- Summary of Quality Differences Request Form
Australia, Canada, Singapore, Switzerland (ACSS) Consortium
- Description of the ACSS Consortium
- ACSS Consortium - Terms of Reference
- ACSS Consortium - Generic Medicines Working Group
- Generic Medicines Work Sharing Trial (GMWST)
- Notice to Applicants - Request for Expressions of Interest (EOI)
- Expression of Interest (EOI) Form (available upon request at email@example.com)
- Operational Procedures (OP)
- Questions and Answers (Q&A)
- Notice to Industry: ACSS - New Chemical Entities Work Sharing Trial Phase I
- Generic Medicines Work Sharing Trial (GMWST)
International Regulatory Forums
International Council for Harmonisation (ICH)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was formed in 1990 to bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. ICH has recently undergone organisational changes. Health Canada is now an official member to the new association since its inauguration on October 23, 2015.
Details of Health Canada's activity with ICH can be found in the ICH section of the Health Canada website.
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