Russian government to simplify launch of new drugs

The Russian government has prepared a bill simplifying the introduction of new drugs into the domestic pharmaceutical market, a spokesman of state press-service has said recently, reports The Pharma Letter’s local correspondent.

At present, before a new drug reaches the consumer, it must undergo a lot of various procedures and checks.

In the case of generics, the duration of laboratory and clinical studies of such drugs may take an average of a year and a half, while for original drugs this could be in the range of five to six years.

For foreign drug developments, Russian legislation requires repeated studies, as the results of foreign studies are not recognized in Russia.

After the completion of the needed studies, a drug developer company must provide documents for obtaining a declaration on the compliance of the drug with quality standards, after which a certificate of conformity is obtained. The latter is issued by accredited state laboratories in Russia.

In the meantime, the Russian Ministry of Health proposes to cancel the certification of each batch of drugs, considering it an excessive administrative barrier.

The Ministry specifies instead of certification of each batch of drugs, a quality control of the imported drug for the first time three batches of drugs and the first three series of drugs, will appear, and will be conducted in state laboratories.

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