03/12/2008

EMEA to be more transparent and give greater access to information on medicines

Source: APM

Allowing greater public access to company drug information lodged with the European Medicines Agency and giving patients a greater say in whether a drug gains marketing authorisation are among priorities for 2009, the regulator said on 2 December 2008.

In a short but wide-ranging presentation at a joint meeting in London between the regulatory affairs organisation TOPRA and the EMEA, Noel Wathion, head of post-authorisation evaluation of medicines for human use spoke of "transparency" on several occasions, saying in 2009 the agency wanted to see "a much higher level of transparency".

He said the EMEA was to "re-open the debate on company confidentiality and see what is the best balance" between protecting companies' commercial interests and improving safety via transparency.

The EMEA would also be putting an "access to documents" policy out for consultation, he said.

Wathion also signalled a continuation of the drive to give patients more influence in the EU's drug regulation process.

Although he gave no details, he said, "this includes the (drug) assessment process".

Elsewhere the EMEA would be focusing on "signal detection" of potential problems emerging once drugs are on the market and it would be playing a part in securing the supply chain from counterfeits.

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