Clinical studies in the registration of imported drugs may cancel
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15 April 2015
market-access-solutions.ru
The Federal Antimonopoly Service intends to initiate a maximum simplification of registration of foreign drugs in Russia. FAS head Igor Artemyev hopes to receive an official commission of the government on this issue. The most likely option to simplify - the recognition of clinical studies conducted abroad with the approval of the drug FDA, EMEA or regulators in other countries.
Mechanisms for access to the market may be several. For example, Russia will connect to the protocol on mutual recognition of clinical trials. In this case, permission to enter the market is obtained automatically. Or other mechanism - written procedures rapid passage in the Russian legislation.
Pharmaceutical companies and patients welcome this decision.
Pharmaceutical companies and patients welcome this decision.
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