Health ministry of the Russian Federation has reached an agreement with the European Union (EU) on the issue of mutual recognition of clinical research, said the head of department Golikova.
(PM) Berlin, 08.11.2011 - "We have to soon sign a document that would address issues concerned the mutual recognition of clinical trials,"
said the Minister after his meeting with EU Commissioner of Health John Dalli. The goal is:
• To regulate standards and practices of clinical research
• If products have already passed in the EU, they should not be conducted again in Russia.
The Minister and the EU Commissioner also discussed the issues of food security and illegal production of drugs.
Golikov recalled that on the 28th of October in Moscow the agreement will be signed by the convention MEDICRIME, which will be the first international legal instrument to provide criminal liability for the manufacture and supply of counterfeit medical products and similar crimes. The meeting also raised issues of infectious diseases and tobacco control. "The results of the meeting, I think, are very positive, I must say that the EU considers Russia as an essential partner, "- said the minister John Dalli.
Chameleon Pharma Consulting comments: This is a good step for even faster registration in Russia. Regulatory experts will have a common basis of reference.