April 28, 2011

On September 1 of this year, the majority of clinical trials in Russia will be in jeopardy. This was discussed at the round table "Business Russia". Clinical Trials   Medicines can not be held because of the new requirements for accreditation procedure of clinical institutions.

Under the new law "On circulation of drugs"   for clinical trials need to be accredited in the mentioned Ministry before September 1, 2011.

Today in Russia there are more than a thousand medical centers and hospital departments in 18 cities of Russia. And as reported by the participants of the round table, to date, accreditation just passed the 11th clinical databases. Analysts are concerned that with the pace of work accreditation to the claimed date will be not more than 50 clinics. Because of that, the study of new drugs have to stop.

Recall that the September 1, 2010 registration of drugs carries Health Ministry   Russian Federation. The work of the department research institutes of the country are not very satisfied. According to Svetlana Zavidovo, Executive Director of ACTO (Association of Clinical Trials), the Health Ministry not only violates the rules of proceedings, incorrectly assigning the authorization number of the study, as well as several times greater than the statutory period of cases. In total only 25% of permits issued during the period. According to the law, within 30 working days after the submission of documents for accreditation agency must make a decision to refuse to grant or issue a permit to conduct research activities.

According to Oakey , Roszdravnadzor previously accredited produces, on average took up to 112 days to issue a permit for study. For comparison, in Europe a similar permit is issued within 60 days.

In addition to the terms of analysts worried about another innovation - Increasing qualification requirements. Thus, the experience of a specialist in research activities increased from two years to five. Thus, automatically depriving the scientific sector 30% of young professionals. In Western countries, such criteria for the qualification of researchers, no.

What threatens the situation for Russia? Manufacturers medicines prefer to choose other, less "problematic" countries for research activities. New drugs will appear in Russia with a delay of up to five years. Also, it will be reflected in the cost of drugs, because they will be imported from abroad. Thus, tens of thousands of Russians suffering from serious illnesses such as cancer, viral hepatitis, HIV, diabetes, etc., depriving last hope for a cure with the help of innovative medicines.