— What are the key results of the Russian State GMP inspectorate?

— First and foremost, I would like to note a positive assessment of Russia’s pre-application for a potential accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). In addition, since 2016 our institution has conducted nearly two thousand inspections of pharmaceutical companies in 71 countries. As a result, 30% of those inspections had negative conclusions, on the basis of which the Ministry of Industry and Trade of the Russian Federation refused to grant a GMP certificate to the companies. The inspectorate activity reached its peak in 2018 and in 2019 a decrease in the number of inspections was observed. It is noteworthy that following the results of the previous year, apart from traditional leaders with respect to rejections – India and China, the anti-rating included the EU countries (Italy, Germany, France and Spain). It is because the majority of the applications had come from the manufacturers of these countries – and, accordingly, they received from us the highest number of remarks. It is pure statistics – nothing sensational

— What would PIC/S give to your country?

— At the outset, I’d like to point out that the Ministry of Industry and Trade of the Russian Federation, Ministry of Health of the Russian Federation, Federal Service for Surveillance in Healthcare and their subordinate institutions received an approval of pre-application for a potential accession to the Pharmaceutical Inspection Co-operation Scheme (PIC/S). At present, a coordination group under the Ministry of Industry and Trade of the Russian Federation has been formed, which is preparing a fully-fledged membership. Without a doubt, Russia’s pharmaceutical industry expects the strengthening of its export potential from the country’s accession to PIC/S.

— Tell us about the development of the GEP (Good Engineering Practice): why is the inspectorate involved in this area?

— In 2018 representatives of the pharmaceutical industry raised a question regarding the quality of engineering companies, which are currently carrying out different projects for them. There was a lot of criticism of them. Consequently, our institute was tasked to explore this issue. By that time, we already had a team with a GEP competency. Having received a concrete task to put things in order in this area, we strengthened our team – recruited the best of the best experts in the field, who began to conduct an expertise of the project documentation, provide assistance in facilitating projects of construction and reconstruction of manufacturing and laboratory facilities. From 2019 onwards we have begun to undertake such work. Consequently, based on the projects submitted for qualification at SID&GP within last year, it can be stated that each project has critical and major remarks from experts, and 38% of the projects, which were qualified, have received even negative conclusions.

— In 2020, are there going to be any fundamental changes in the pharmaceutical market?

— Major changes in the market have already taken place: the structure of drug circulation in Russia has changed; the world community has faced a new challenge – the virus COVID-19, which will undoubtedly have a serious impact on the economy. The Ministry of Industry and Trade of the Russian Federation has already noticed a slowdown in a number of industries due to movement restrictions of citizens and trade flows.

In accordance with the order of the Ministry of Industry and Trade of the Russian Federation, since February 4, the GMP-inspections of a number of Chinese drug manufacturers have been cancelled. Due to an outbreak of the virus in Italy, the Ministry of Industry and Trade of the Russian Federation has approved to cancel inspections of the company in the quarantine province of Lombardy, which was scheduled for March. In those regions where quarantine has not yet been introduced, but cases of coronavirus have been identified, a desk-top assessment regime has been introduced in order to minimize the health threat risks of citizens traveling on business trips.

Once the situation in these regions is normalized, the inspection schedule will be adjusted and we will certainly continue conducting inspections.

In 2020, various Good Practices will be developed. For example, more often our GDP (Good Distribution Practices) accredited inspectors receive requests from representatives of the pharmaceutical industry due to, among other things, the development of these practices in the EAEU.

A number of issues will be dedicated on good manufacturing and quality assurance of biologically active additives and specialized

nutrition. Currently, a number of GMP-certified pharmaceutical manufacturers are releasing biologically active additives in accordance with the same standard. For the most part, however, the market of biologically active additives – is not pharmaceutical products. And although certain technical regulations have been developed for them, today there are no procedures or set of regulations governing the unified principles of the organization of biologically active additives manufacturing. To harmonize approaches concerning biologically active additives manufacturing, that are widely applied to correct pathological conditions of citizens as an auxiliary additive for the basic therapy, the biologically active additives should have certain tolerances in respect of products quality and the organization of manufacture, excluding risks of cross-contamination.

We will also have to solve the issues related to the creation of the EAEU single pharmaceutical market, this is because from January 1, 2021 only GMP certificates issued under the EAEU rules will be accepted and recognized within the EAEU. Among such issues, the question of the need to create a single EAEU GMP-inspectorate is being raised more frequently. In general, this year promises to be full of both events and changes, the results of which we will talk about at the V GMP Conference on September 30.