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Published on 15 January 2008

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Regulators agree information deal

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Pharmaceutical regulators in the EU and Canada have signed an agreement to exchange confidential information about the authorisation and safety of medicines.

The proposals were approved by the European Commission and the European Medicines Agency (EMEA) on one side, and the Health Products and Food Branch of Health Canada on the other at a bilateral meeting in Brussels.

The watchdogs will be able to exchange information on issues such as safety problems with medicines already on the market, and therapeutic products under development or being considered for authorisation.

It is hoped that closer cooperation between the authorities will make it easier and quicker to take action to protect public health.

Officials in the EU and Canada have been working together for a number of years in the area of medicines and 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).

A statement said: “The new confidentiality agreements 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.”

Copyright © PA Business 2008

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