On July 16, 2012, the Director General of the European Medicine Agency (EMA) decides to make public the scientific archives of the Agency

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The European Medicine Agency (EMA) is the European regulator responsible for ensuring the proper coordination of regulations of member states and centralize information on medicines that are placed on the European internal market.

July 16, 2012, the Director General of EMA said that now the archives of the Authority will be available to the public, which could allow independent researchers to analyze hundreds of thousands of pages of results of clinical trials conducted by industry.

The regulator requires well beyond the principle of information, availability thereof, of contralisation thereof, the principle of transparency.

This does not self-evident, because if the authorization to market is a public decision, clinical trials are conducted by companies, according to the laboratory, protected by trade secrets. But the new Director General of EMA, Guido Rasi, who took office in January, because of successive scandals indûments put drugs in circulation, has decided that the opposite principle of transparency should prevail.

The drug regulatory system in itself is changed.

Indeed, regulation is a far operated bilaterally between the pharmaceutical company and the administration in charge of issuing the authorization for placing on the market. With this decision, which paves the information on all the scientific tests that led to these decisions, we move from a bilateral system to a system open to all, that is to say to a system more in line with the regulation other regulated sectors.

Therefore, this simple decision is symptomatic of a major movement in the design of pharmaceutical regulation.

Thus, the medical director of the EMA presented: "" This is a radical change of attitude ".