The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) in the European Union (EU) have released a guidance document on the identification of commercially-confidential information and protection of personal data within marketing authorisation (MA) applications.
The draft document, which is now out for public consultation until September 1, outlines the types of information included in MA applications that can be released following a request for access to documents, once an MA has been granted.
The consultation is being conducted to gather the views of stakeholders, including pharmaceutical companies, health care professionals and patient groups. The EMA and HMA say that they are particularly interested in receiving comments on the criteria for 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.
The principles in the document, which represent the outcome of extensive discussions between the Agency and the HMA, aim to achieve a greater level of transparency and to address requests for information coming from the public more effectively, say the agencies.
Following the consultation period, the Agency and HMA will work together to assess all comments received before agreeing on a final version of the guidance document, and this final version will apply to applications received by both the EMA and by the medicines regulatory authorities of the EU member states. However, the latter authorities will also be required to follow EU or national legislation on access to documents, the EMA and HMA point out.
