The Medsintez Plant has outlined ways to solve the difficulties that Russian pharmaceutical enterprises face when entering international markets in the VIII All-Russian GMP Conference

On September 27, as part of the business program of the GMP conference with international participation, Alexander Petrov, Chairman of the Board of Directors of Medsintez Plant LLC, took part in a Plenary Session on the issues of regulating the circulation of medicines in Russia and the EAEU, developing import independence, and increasing export potential. The session was attended by representatives of the Ministry of Industry and Trade of the Russian Federation, the Minister of Health of the Republic of Nicaragua, the WHO Representative in Russia, a Representative of the Serbian Ministry of Health and other Russian and foreign experts. Mr. Petrov spoke about the problems that Russian pharmaceutical companies face when entering international markets and suggested possible solutions.

As a manufacturer, the Medsintez Plant is interested in the constant development and expansion of the sales market for its products. Today, the company is implementing several international projects to introduce products to the markets of other countries, such as South Africa, Pakistan, and Vietnam.

“We see that foreign countries are interested in the supply of vital drugs, and Russian enterprises have experience, competencies and production capacity. International projects for pharmaceutical enterprises are an opportunity to develop potential, increase production levels, and also recognize the quality of Russian products in the world. In the current economic situation, it is very important to develop this area, and it is important for manufacturers to have regulatory support measures,” Mr. Petrov noted.

As part of the implementation of projects, Medsintez Plant, like other Russian pharmaceutical enterprises, faces certain difficulties that lengthen the process of registration and launch of products on international markets. The success of a project to promote pharmaceutical products in a foreign country directly depends on three main factors: confirmation of the organization of production to GMP requirements, the quality of the registration dossier, as well as the registration procedure and interaction with state regulatory authorities.

Currently, the EAEU GMP requirements are not recognized as equivalent to the WHO and EU GMP requirements, and therefore the GMP certificates of the Russian manufacturer are not recognized by the regulators of foreign countries. As a consequence, there is a need for inspection of production by a regulatory body of a foreign country. There are also difficulties in registration dossier preparation, as there are different approaches to expertise within the registration and the scope of documents. Each country, despite the uniform international requirements, puts forward its own recommendations on their completeness. The implementation and timing of market entry of medicines directly depends on the registration procedure and interaction with regulatory authorities. In some countries it is not possible to enter the market without a representative company (resident of the country); a number of countries do not allow registration of a product that is not registered in a country with a stable regulatory system (PIC or PIC/S countries).

“In order to ensure sustainable development of the Russian pharmaceutical industry, as well as support for pharmaceutical manufacturers, assistance and support from the Russian regulatory authorities are needed to address such issues as Russia's accession to PIC/S, recognition of EAEU GMP requirements as equivalent to other global GMP standards, which will lead to the recognition of Russian GMP certificates in other countries. It is important to harmonize the requirements to the scope of the registration dossier at the level of regulatory authorities of countries interested in the supply of Russian medicines, as well as to develop manufacture support mechanisms from the regulator, including methodological ones, to simplify the procedure for entering the markets of other countries,” Mr. Petrov summarized.