The Russian State Institute of Drugs and Good Practices, part of the Ministry of Industry and Trade, plans to inspect five British pharmaceutical manufacturers for compliance with good manufacturing practice (GMP) in 2019, the institute’s director Vladislav Shestakov has said, according to RIA.
On Tuesday, the institution signed a cooperation agreement with the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), which will also take part in the inspections, Shestakov said.
According to him, the first inspection will take place in March at Norgine; 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 U.S., France and others.