03 March 2009

Pharma 2020: another obstacle

FAS recognized: in the field of registration of medicines in Russia – a mess

The successful implementation of the Pharma 2020 pharmaceutical industry development strategy is under threat, according to the Federal Antimonopoly Service. As stated in the statement of the Association of Russian Pharmaceutical Manufacturers (ARFP), at a joint meeting, the head of the Department of Social Sphere and Trade of the Federal Antimonopoly Service Timofey Nizhegorodtsev emphasized: both with the existing system of registration of medicines, and taking into account the proposed amendments to the law "On Medicines", the probability of successful implementation of the Development Strategy of the Russian pharmaceutical industry until 2020 is reduced to minimum.

The registration system does not allow companies to quickly launch new generic and even more innovative products on the market. Mr. Nizhegorodtsev noted: The FAS shares the opinion of the ARFP on the need to cancel the registration of substances, as a provision that puts Russian and foreign manufacturers in non-competitive conditions. Moreover, the FAS official drew attention to the fact that the procedures for state registration of medicines in the draft law "On Amendments to Federal Law No. 86-FZ "On Medicines" are not clearly prescribed and do not contribute to reducing the time and streamlining procedures in this area. Therefore, the FAS issued a negative opinion on the bill.

In addition, even the current norms of the law are not enforced. According to the existing requirements, the term of registration of a medicinal product on the Russian market cannot exceed 6 months from the date of filing an application. However, in practice, registration periods reach two or more years, and, as a rule, are absolutely unpredictable. For pharmaceutical companies, this means that it is impossible to plan economic activities.

Mr. Nizhegorodtsev noted that the Federal Antimonopoly Service has information about the existing violations of the requirements established by law in the registration of drugs and will take appropriate actions to eliminate them.

Michael is found, STRF.ruPortal "Eternal youth" www.vechnayamolodost.ru


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