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Regulatory Update

Posted 01 February 2009

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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