More than 800 pharmaceutical industry experts took part in the GMP Conference 2024, which was held in Ufa, both offline and online. The main topic of discussion was the continuous development of the manufacture of effective, high-quality and safe medicines, expansion of international dialogue, and improvement of regulatory systems.

Continuous development

At the Conference, in the welcoming speech, the Minister of Industry and Trade of the Russian Federation, Mr. Anton Alikhanov, emphasized that today the pharmaceutical industry of Russia is one of the most progressive areas of technological development of the country, and continuous improvement of the pharmaceutical quality system and the introduction of good manufacturing practices at Russian facilities ensure the reliability of domestic products.

The Director of the Department of the Pharmaceutical and Medical Industry Development of the Ministry of Industry and Trade of Russia, Mr. Dmitry Galkin, cited important indicators of the domestic pharmaceutical industry: the total number of active manufacturers in our country is 553, the growth of the Russian pharmaceutical market from 2018 to 2023 was about 120%, and 2 out of 3 packs sold today are domestically produced medicines.

In the last decade, the manufacture of medicines has been developing at a rapid pace. For example, the production of advanced therapy medicinal products, blood products and other medicines is gaining momentum. The domestic production of active pharmaceutical ingredients is being upscaled. New pharmaceutical facilities are being built, production complexes of existing pharmaceutical sites are being improved and their range of products is being expanded. This was brought to light by the Director of SID & GP, Mr. Vladislav Shestakov.

Put that in context, in the city of Ufa, which hosted the Conference in the year of its 450th anniversary, in December 2023, the Pharmstandard company launched the production of Factor VIII medicines for the treatment of hemophilia A. This is the first large-scale production of Factor VIII in the country. This year, the site has been running at its full capacity, and in the future it is planned to expand production through the construction of new buildings.

According to the General Director of JSC Pharmstandard, Mr. Dmitry Zaitsev, such large-scale investments and successful development are possible due to a combination of several factors – the growing demand of citizens for high-quality medicines, the widening competencies of Russian manufacturers, as well as government support measures, including federal programs and national projects.

International dialogue and cooperation

The great interest in the GMP Conference from foreign partners year in and year out allows for an international dialogue on pressing issues of intercountry cooperation in pharmaceutical production. This year alone, representatives from 23 countries, as well as WHO, took part in the event, both offline and online. Reports were presented by Cuba, India, Myanmar, the Philippines, the People’s Republic of Bangladesh, Montenegro, Egypt, Nigeria, Algeria, Tunisia, Uruguay, Ecuador, Peru, China, Indonesia, Uzbekistan, Azerbaijan and the EAEU member states.

The topic of developing relations within the EAEU common market of medicines was given special attention, since this year the Union turns 10 years old.

“Today, several key areas of development are relevant for all countries of the Eurasian Economic Union. They include the improvement of the laboratory competencies, the availability of accredited laboratories for conducting pharmaceutical expert evaluation, the creation of a platform for clinical trials, the training of highly qualified experts for the development of new medicines, the introduction of technologies for in-demand innovations,” said the Head of Registration and Pharmacovigilance of the CIS Region, Representative Office of Gedeon Richter OJSC, Ms. Natalia Volovich. According to her, “On the one hand, the states are striving to create the EAEU common market, and on the other hand, each of them is interested in developing its own industry. In order to establish effective cooperation, it is necessary to continue to develop dialogue and seek reasonable compromises in order to maintain a balance of interests for the benefit of patients in all countries.”

“We are PRO GMP” competition

For the first time within the Conference, an interactive competition was held, where participants voted for the best moderator, best speaker and best report of the event.

«Best Moderator» nomination:

• Mr. Dmitry Somov, Director of the Federal State Budgetary Institution “Information and Methodological Center for Expert Evaluation, Accounting and Analysis of Medicines Circulation”.

«Best Speaker» nomination:

• Mr. Wissem Achour, Deputy Director for Inspections, National Agency of Pharmaceutical Products (Algeria);
• Ms. Cecilia Martinez Rossi, Director of the Inspection Department of the General Directorate of Inspection (Uruguay);
• Ms. Chinara Mambetalieva, Deputy Director of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission.

«Best Presentation» nomination:

• Ms. Carolyn P. Custodio, Regional Supervisor, Food and Drug Administration (Philippines);
• Mr. Myo Zarni Saw, Director, FDA (Myanmar);
• Mr. Alexey Pavlov, Director of BMC Nanolek;
• Ms. Faiza Yagudina, Quality Director of Akrikhin.

Today and tomorrow

During the three days of the business program, Conference participants managed to discuss the most relevant areas of development in the industry: peculiarities of the production of biological medicinal products, approaches to building a quality system at facilities, licensing issues, personnel training and employee competencies in GMP, and much more.

Besides, three master classes were held (“Authorized Persons”, “Licensing”, “Inspection”), where regulators and highly qualified experts exchanged practical experience with employees of pharmaceutical companies in the format of business games.

Next year will be the tenth anniversary year of the Pan-Russian GMP Conference. The venue for the event will be announced later.

Key figures of the GMP Conference:

• 3 days
• 23 countries
• 12 sessions and 3 master classes.
• 700 offline participants and over 100 online
• About 100 speakers
• 12 exhibitors
• 20 information partners
• More than 25 media representatives on site

The event is organized by the Ministry of Industry and Trade of the Russian Federation and the State Institute of Drugs and Good Practices (SID & GP). The Conference’s operator is the Corporate Communications Center S-GROUP.

General partner: Pharmstandard.

Strategic partner: Gedeon Richter.

Partners: R-PHARM, SC Pharmasyntez.

Special partners: Valenta Pharm, Makiz-Pharma, PharmFirma Sotex, SKOPINPHARM, Nanolek.

Session partners: Promomed, PRO.MED.CS Praha a.s., Natsimbio.

Exhibitors: Sofrinskiye Packaging Manufactories, AiX LAB, CLEANTECH, Gluvex.