Closer Ties On Medicines Safety Between European And Canadian Regulatory Authorities
This closer cooperation between the authorities will provide earlier access to information and thus make it easier and quicker to take action to protect public health. Sharing information and expertise will help both the Canadian and EU authorities to further strengthen public health protection.
The European Commission's Directorate-General Enterprise and Industry, the European Medicines Agency (EMEA), and the Health Products and Food Branch of Health Canada have concluded confidentiality arrangements in the area of medicines and therapeutic product regulation during their bilateral meeting of 7 December 2007 in Brussels.
The EU and Canada have been working collaboratively for many years in the area of medicines and therapeutic product regulation. This has included a mutual recognition agreement on manufacturing of medicines, through the International Conference on Harmonisation (ICH) and the International Conference on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH).
The new confidentiality arrangements build on the previous cooperation and will allow exchange of information between the parties as part of their regulatory and scientific processes, both before and after a medicine has been approved.
The types of information covered include:
- position papers on future legislation and/or regulatory guidance documents;
- scientific advice on product development given to companies to promote innovation;
- assessments of applications for marketing authorisations; and
- information about the safety of marketed medicines to better protect public health.
The potential benefits of this exercise are expected to include:
- accelerated access of patients to new and innovative medicines;
- improved performance and safety as a result of the involvement of the best available regulatory expertise from both the EU and Canada.
Background
Scope of products covered in Europe: The confidentiality arrangements cover human and animal medicines subject to evaluation or authorised under the centralised authorisation procedure as well as medicinal products authorised at national level by the EU Member States that are subject to official EU arbitration and referrals.
Scope of products covered in Canada: includes pharmaceuticals, radiopharmaceuticals, biologics and natural health products.
The confidentiality arrangements are established by an exchange of letters which can be accessed here:
- Letter from EC and EMEA
- Letter from Health Canada
For more information on the work of the Commission's Pharmaceuticals Unit see here.
European Medicines Agency
Legãturi mai strânse privind medicamentele pentru Siguranþa Între europene ºi canadiene Autoritãþile de reglementare - Closer Ties On Medicines Safety Between European And Canadian Regulatory Authorities - articole medicale engleza - startsanatate