The European Medicines Agency and the Heads of Medicines Agencies (HMA) have released a guidance document on the identification of commercially confidential information and protection of personal data within the structure of the marketing-authorisation dossier for public consultation.
The draft document, which is open for comment until 1 September 2011, outlines the types of information included in marketing-authorisation applications that can be released following a request for access to documents, once a marketing authorisation has been granted.
The consultation is being conducted to gather the views of stakeholders, including pharmaceutical companies, healthcare professionals and patient organisations. The Agency and the HMA are particularly interested in receiving comments on the criteria for the release or protection of personal data, whether contractual arrangements between companies need to be maintained as confidential, and how to address the personal security of individuals involved in studies using animals. They are also inviting stakeholders to make proposals on how to make these types of request easier.
For more Information please click: EMA Guidance Document for protection of personal data
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