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Site Inspection – Not for Everyone Yet

Participants of conference “State Regulation and Russian Pharmaceutical Industry 2016: Continuation of Dialogue”, held on March 31 in Moscow, discussed prospects and possibilities of the united EEU market. Particular attention was paid to the problem of regulatory base. The issues discussed included conditions of launch at the united EEU market, mechanisms of mutual recognition of drug registration and legal enforcement of integration processes in the field of drug circulation. An actual issue of inspection for GMP compliance of manufacturing sites of international manufacturers was discussed today as well.

Victor Dmitriev, General Director of ARPM remarked that if no clearly defined schedule of inspection of substance manufacturers is prepared, there will be problems with drug manufacture and pharmacological provision in general.

ARPM representatives have agreed that in the near future there will be no inspection of sites manufacturing substances not intended for sale. The marketing authorization dossier will account for the substance supplied, while the quality of the drug will be the responsibility of the manufacturer.

The same topic was discussed last week at the meeting at the Ministry of Industry and Trade. It was decided to perform no GMP inspections for the foreign sites manufacturing substances not intended for sale. Therefore, now only sites manufacturing substances for sale will be inspected.

In the future it is planned to develop an inspection schedule of international pharmaceutical manufacturers and set a transition period of minimum two years, when in the presence of marketing authorization certificate drugs will be allowed to continue circulation in the Russian market.

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