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EMA clarifies what marketing application information is protected

But pharma industry raises concerns over release of pre-clinical data

The European Medicines Agency (EMA) had produced guidelines to explain what information is protected in a company's marketing authorisation application (MAA).

The document aims to implement a 'harmonised' approach across Europe for national regulatory authorities to handle requests for access to documents by clarifying what constitutes commercially confidential or personal data.

The EMA, which produced the guidance with the Heads of Medicines Agencies (HMA) network, said the guidelines would be the first time a consistent Europe-wide approach to identifying such information would be available.

Regarding commercially confidential information, the EMA said the guidance limits the scope of what information companies can protect.

Information not deemed to be confidential will mainly relate to the quality and manufacturing of a medicine, the company's facilities or equipment, as well as some contractual arrangements between companies.

Personal data will also be defined by the directive (EU Directive 95/46/EC), and will be protected if it can lead to the identification of a person. Guidance is also offered on how to identify personal data that needs to be redacted.

“This initiative will help the authorities in the network to cope with a growing number of requests for access to clinical and safety data contained in a marketing authorisation application,” EMA said in a statement.

However, the proposal has received some criticism from the pharma industry, with the European Federation of Pharmaceutical Industries and Associations (EFPIA) raising concerns over the release of non-clinical, or pre-clinical, data.

“The worry in the industry is not that data itself is made available, but the fact that data will be available for all sorts of reanalyses. It is important that EMA communicate best practices for re- and meta-analysis of data,” EFPIA said.

The Federation did, however, say it welcomed moves for greater transparency and the release of data from clinical trials.

The EMA's guidance does not cover filings for orphan designations, paediatric investigation plans and veterinary medicines.




29th March 2012


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