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:
Strong relations and dialogue with international counterparts are also important in achieving program objectives in an increasingly complex regulatory world.
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.
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.
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.