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EMEA transparency policy consultation

Comments are being invited by the European Medicines Agency on its draft transparency policy, up to September 25, 2009

Comments are being invited by the European Medicines Agency (EMEA) on its draft transparency policy, up to September 25, 2009.

Since its inauguration in 1995, the EMEA has worked to improve the transparency of its operations, often going beyond existing legal requirements. The new draft policy describes its vision on openness in one comprehensive document.

The policy proposes to focus on three main objectives. The first is to concentrate on daily operations and will reassess the balance between transparency and protection of commercially confidential information. This will lead to more proactive disclosure of information about the scientific evaluation of medicines and will better explain how the EMEA operates and reaches its scientific conclusions. 

The second aspect is to strengthen the EMEA's interaction with its stakeholders, particularly patients and healthcare professionals. Existing methods will be developed with a view to greater consultation with them on the scientific evaluation of medicines at scientific committee level. 

The final objective is to promote a harmonious approach to transparency across the European medicines network. The EMEA will work closely with medicines regulatory authorities in the EU to provide this. 

The EMEA will hold a second workshop on transparency in October 2009, to analyse and review comments and feedback. The draft transparency policy will be updated accordingly before its final adoption and publication, which is planned for the end of 2009.

View the draft EMEA transparency policy at:
http://www.emea.europa.eu/pdfs/human/transparency/23203709en.pdf (pdf)

24th June 2009

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