Moscow Hosts the X GMP Conference Under the Motto “Regulating Today — Creating a Stable Tomorrow”

September 16, Moscow | The business program of the X All-Russian GMP Conference with international participation covers a wide range of issues related to ensuring quality in the production of medicinal products, regulatory affairs, interagency and international cooperation in the pharmaceutical industry.

The Plenary Session was attended by the Minister of Industry and Trade of the Russian Federation, Anton Alikhanov; the Minister of Health of the Russian Federation, Mikhail Murashko; the State Secretary – Deputy Minister of Agriculture of the Russian Federation, Maxim Uvaidov; the Minister of the Moscow City Government and Head of the Department of Investment and Industrial Policy of Moscow, Anatoly Garbuzov; the Chairman of the All-Russian Public Organization “Business Russia”, Alexey Repik; and the Acting Director of the Medical Research and Educational Institute of Lomonosov Moscow State University, Vsevolod Tkachuk.

The high-profile speakers of the discussion represented the main segments of the modern medicinal product quality assurance system. The session was moderated by Vladislav Shestakov, Director of the FSI “GILS & NP”.

In the sphere of implementing Good Practices, the pharma industry has come a long way from adapting international standards and developing national rules to transitioning to Eurasian legislation.

Since 2014, GMP Rules have become mandatory in Russia. Assessing the results of their implementation, the Head of the Russian Ministry of Industry and Trade, Anton Alikhanov, noted that integration with international norms and the creation of the GMP inspectorate were part of the “Pharma 2020” Strategy for the Development of the Pharmaceutical Industry. During this time, Russian inspectors have conducted about 7 thousand inspections both in Russia and abroad. Currently, within the framework of the updated “Pharma 2030” Strategy, new tasks have emerged. These include significant work with colleagues from the World Health Organization, jointly with the Russian Ministry of Health and other agencies, and extending quality control not only to finished dosage forms but also to pharmaceutical substances. Furthermore, new preferences for Russian manufacturers are being developed. Today there are over five hundred of them, and they already export medicinal products to more than 150 countries.

Good Practices are the foundation of the healthcare system in terms of ensuring the quality, efficacy, and safety of medicines. Mikhail Murashko expressed the opinion that GMP Rules must always be upgraded with the focus should be prioritized not only on the domestic market but also on exports. Agreements already exist in this direction, allowing for the creation of a preferential zone for Russian manufacturers in promising markets of a number of foreign countries. He also noted that medicinal product manufacturers proved themselves during the difficult period of the COVID-19 pandemic, coping with new challenges in the interests of the healthcare system and patients, and today continue to solve complex tasks in changing conditions.

Among the conference speakers are more than 10 representatives of regulatory authorities from EAEU member states and the Eurasian Economic Commission, and 38 experts from 27 countries worldwide, including states from Asia, Africa, the Middle East, and Central and South America.

At the session dedicated to the common market of medicinal products for human use in the EAEU, issues of harmonizing the legislation of member states were discussed, driven by the course towards globalization of the pharmaceutical market due to its high innovativeness, research intensity, and long cycle of development and market launch of new drugs.

Dmitry Rozhdestvensky, Head of the Section for Coordination of Work in the Sphere of Circulation of Medicinal Products and Medical Devices of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission, stated that over the past 10 years, the common EAEU market has achieved maturity of regulatory systems. Over the last two years, the WHO has visited all five Union states, and one of the most important factors in assessing the regulatory system was precisely the system of medicinal product circulation. Each of the five states reported using union procedures. An example of the Union’s economic advantage is optimized costs. One legal consequence is increased transparency in dossier compilation procedures. The main achievement for the consumer, however, is the accessibility of information about all medicinal products.

Over the three days, the GMP conference will discuss interaction between manufacturers and regulatory bodies within the framework of licensing medicinal product production, issues of inspecting sterile medicinal products considering changes in GMP requirements, approaches to organizing the production of medicines containing hazardous substances, the design and operation of microbiological laboratories at pharmaceutical manufacturing sites, specifics of localizing ATMPs (Advanced Therapy Medicinal Products), and other practical issues.

The detailed business program of the GMP conference can be found on the event website.

Live updates from the event are available on the Telegram channel Про GMP.