emealogo2.jpg (2881 bytes) The European Agency for the Evaluation of Medicinal Products
Human  Medicines  Evaluation  Unit
London, 18 February, 1998
RB/ELM/dep/2/1
Direct Line + 44.171.418.8411
M. Charles Medawar
Social Audit Ltd
P.O. Box 111
London NW1 8XG

Dear Sir

Thank you for your letter enquiring about the role of the EMEA/CPMP in the assessment of the risk of dependence on the SSRI antidepressants raised in your enclosed article and for comments about transparency and potential conflict of interest within the EMEA/CPMP system including expert advisors.

It is the direct responsibility of the EMEA/CPMP to assess the pharmacovigilance issues relative to centrally authorised products, and when there is a CPMP referral about these matters under article 10, 12 or 15 of Council Directive 75/319/EEC for a medicinal product authorised in Europe through a national or a mutual recognition procedure. For a more detailed information about the EMEA/CPMP role in Pharmacovigilance, please find enclosed the CPMP Guideline

"Conduct of Pharmacovigilance for centrally authorised products" where the roles and responsibilities of all partners are clearly described. This document is also available on the Intemet at http://www.eudra.org/emea.html.

The safety issue raised in your article refers to non-centrally authorised medicinal products and a review of products marketed by national competent authorities has been initiated. Your enclosed paper "The antidepressant Web" has been distributed to all the relevant experts. Evaluation of the risk of dependence on SSRI antidepressants has been initiated.

The new European system is based on the co-operation between the national competent authorities of the Member States and the EMEA. The members of the two scientific committees of the EMEA, the CPMP and the CVMP are nominated by Member states and chosen by reason of their role and expertise in the evaluation of medicinal products. As members of the scientific committees, they act independently of their nominating authority. Their independence is also shown by a declaration of interest and curriculum vitae. The EMEA list of experts, together with their declaration of interests is available to the public at the EMEA.

A major consultation exercise was carried out in the first half of 1997 on transparency and access to documents of the EMEA. Responses to the consultation paper and the rules to access to documents formed the basis of a workshop held on 30 October 1997. This meeting was a first opportunity for a number of National Authorities and representatives from a wide range of consumer, patient, pharmaceutical industry and media group to discuss the issues of transparency. On the basis of this workshop, the EMEA will continue to explore with the CPMP and the CVMP, further initiatives towards even greater transparency in the operation of the EMEA.

Yours sincerely

Prof Rolf Bass
Head of Human Medicines Evaluation Unit

 

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Email: mail@emea.eudra.org http://www.eudra.org/emea.html

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