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The Federal Antimonopoly Service has proposed recognition of the clinical trials registered by FDA and EMA

The Federal Antimonopoly Service has proposed recognition of the clinical trials registered by FDA and EMA

We tried to find out what the experts from the professional community think about this regulatory initiative.

As we were explained by Evgeny Averin, MD, the new regulation has to do with the drugs submitted for registration in Russia, whose efficacy and safety have been proven in the EU and the United States.

"So far, according to the Russian health laws, the international pharmaceutical companies were required to conduct the local clinical trials with the aim of further registration of their products in this country. And that process could take several years. Both the US Food and Drug Administration and the European Medicines Agency have earned an excellent reputation in the world. Among other things this can be proved by the fact that when either of the two issues a warning to the drug product of a particular pharmaceutical company, the stock value of the latter usually goes down. Therefore, the FAS proposal seems quite reasonable. It will not only reduce the cost of the launch of the drug, but would also speed up the market entry. This, in turn would make a larger number of up-to-date and innovative medicines available to health practitioners and patients."

This view is shared by another respondent, Sophia Demura, the Medical Director of Aston Group.

"Today, the time required for the registration of a foreign-made medication in Russia is anywhere from three to five years, depending on the clinical trial protocol, - explains the expert. - But in addition to this, the procedure is quite expensive, which ultimately affects the cost of the drug.

Some time ago, FDA and EMA originated the development of the guidelines on GMP* and GCP** and for several decades now they have been used to monitor efficacy and safety of medicines in Europe and the United States. Therefore, by facilitating the drug registration process the health authorities make a substantial contribution to improving the supply of medicines to patients and increasing the effectiveness of treatment. Moreover, the reduction of registration costs will positively affect the pricing of the foreign drugs."

*GMP - Good Manufacturing Practice

**GCP - Good Clinical Practice

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