The decision will expedite registration for medical drugs.
As per a resolution signed by Prime Minister Mikhail
Mishustin, foreign pharmaceutical companies will now be able to more promptly
cooperate with Russian agencies overseeing compliance with manufacturing
standards and practices.
The State Institute of Medical Drugs and Good Practices is the body responsible for compliance inspections in Russia. The institute conducts audits of foreign production companies, followed by reports for subsequent issuance of compliance statements, which are required for registration of drugs.
Previously, foreign pharmaceutical manufacturers could only confirm having rectified any faults found by state oversight agency during the next inspection. From now on, in the event of any non-compliance, foreign companies can submit a rectification plan even before the inspection report is finalised.
The amendments approved by the Prime Minister will facilitate access for foreign medications to the Russian market. The resolution will also help to bring Russian law in line with the EEC Council’s Rules for Conducting Pharmaceutical Inspections.