Russia to Inspect British Pharma Manufacturers

06 February 2019

GMP News

The Russian Ministry of Industry and Trade’s State Institute of Drugs and Good Practices plans to inspect five British pharmaceutical manufacturers for compliance with GMP standards in 2019. That’s according to the institute’s director, Vladislav Shestakov.

He pointed out that on Tuesday they signed a cooperation agreement with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), which will also take part in the inspections.

According to Shestakov, the first inspection will take place in March at Norgine Ltd; in April the institute will inspect the production facilities of the Central Pharma and Fleet Laboratories. Then, in May and June, they will inspect SmithKline Beecham and Genzyme.
Regarding the agreement with the British regulator, Shestakov pointed out that the cooperation with the MHRA started two years ago, and it took a year to prepare the cooperation agreement.

This year we’re planning to carry out five inspections, and we invited our British colleagues as observers in these inspections. We are open for cooperation? - the head of the institute said.

In 2018, the institute carried out inspections in 57 countries whose drugs enter the Russian market. According to Shestakov, in Russia, British medicines are ranked fifth, after countries such as Germany, the US, France and others.

Since 2016, we’ve conducted 46 inspections in the UK. Of these, eight companies didn’t meet our requirements. We hope that after signing the agreement, the British regulator will be more actively involved in our inspections and training checks, both in Russia and Britain. The signing of the agreement proves that despite the political tensions between our countries, our experts continue to cooperate, which has a positive impact on the dynamics of the development of our trade relations. In the context of Brexit, the UK is extremely interested in developing business and regulatory relations with other countries, including Russia, - Shestakov concluded.



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