Regulatory Update

Posted 01 February 2009 | By

On 18 December 2008, the European Medicines Agency (EMEA) published its proposed policy for making public the agency's documents. Comments on the proposed policy are due by 2 March 2009. The policy's scope extends to human and veterinary medicinal products. The policy does not apply to working documents, only documents where the decision-making process has been concluded. It includes a provision for redacting documents for the protection of confidentiality and personal data. EMEA proposes implementing the public access policy in two phases. The first phase concentrates on adequate follow-up to written requests for access to documents. The second phase includes the gradual population of an electronic registry of EMEA documents on the agency's website.


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