157 license holders out of 189 manufacturing sites have received a GMP-certificate following the procedure of filing an application

In anticipation of the Russian Investment Forum, today, in Sochi, the Healthy Life Forum has been started with its key topic being the system of universal health coverage aimed at achievement of the 78-year lifetime by 2024. One of the sub-topics of providing Russian citizens with high-quality medicines has been outlined as GMP-inspections carried-out at pharmaceutical manufacturing sites.

Today, inspections of pharmaceutical manufacturers in the context of providing the population with high-quality medicines manufactured in compliance with GxP standards have been discussed at the subject-matter Forum in Sochi with debates around hot topics of universal health coverage. As it has been reminded by the Director of FSI «SID & GP» Mr. Vladislavl Shestakov, in the Russian Federation, compliance of local manufacturers of medicines with GMP guidelines is confirmed by holding a license, based on which a GMP certificate can be obtained following the procedure of filing an application. Based on the official register of manufacturing licenses maintained by Minpromtorg of Russia, as of the end of 2018, drug manufacturing activities are performed by 498 license holders.

«Last year, 325 license-targeted inspections were carried-out. In total, 185 prescriptive orders were issued. There were 20 cases of refusals to issue a license and 41 licenses were suspended», emphasized Mr. Vladislav Shestakov. «As of today, 157 license holders out of 189 manufacturing sites have received GMP certificates following the procedure of filing an application.»

Local manufactures need such a certificate for exporting medicinal drugs in particular.

As for foreign manufacturers having their products circulating within the Russian Federation territory, when filing for registration of a new product or re-registration, or when making changes to registration documents (in case of changes in the location of manufacture, quality control methods, API listing in the register), the package of documents to be submitted by foreign manufacturers shall contain a Conclusion on Manufacturer’s GMP Compliance.

«Being the authority empowered by Minpromtorg of Russia to carry-out inspections, we must make sure that the manufacturing site complies with GMP guidelines effective within the Russian Federation territory», explained the Director of DSI «SID & GP». «Besides, based on our experience, one and the same product can be manufactured using different production lines and under different conditions for different markets.» The Institute’s database has the information that 2018’s inspections of Big Pharma companies and other foreign companies resulted in a share of refusals to issue a conclusion of GMP compliance of about 30% in average (with 16% being related to Big Pharma companies). One of the most severe non-conformities being the reason for a refusal is connected with manufacture of sterile drugs, when companies do not conduct an investigation to find a root cause of non-sterility.

Answering the question about when all pharmaceutical manufactures will hold a GMP certificate, Mr. Vladislav Shestakov noted that «All foreign manufacturers will have it [a GMP certificate] as soon as the information provided in the registration file is in line with the actual process implemented at the manufacturing site. It’s impossible to outline an exact date because, as you all know, on the one hand, we witness a trend of localization of foreign companies in the Russian market. On the other hand, SID & GP routinely expands its cooperation with inspectorates from other countries striving for mutual recognition of the results of GMP audits.»