Polina Dombure

Many Russian pharmaceutical companies are convinced that they are going to fact insurmountable barriers on the way to entering international markets. From my point of view, now the main barrier within companies is fears and insufficient knowledge of regulatory procedures in other countries. Today, most production sites in Russia largely meet the standards necessary for entering international markets.

We know from experience that, on the one hand, the manufacturer’s confidence in the readiness of its site for audit is often justified. On the other hand, despite the fact that everyone works in the same regulatory field, each inspector has an individual approach to conducting an audit. This may be due to the inspectors’ education or their previous experience. For example, a chemist, a biologist and a microbiologist will pay attention to different aspects while conducting the check. In addition, when preparing customers for GMP inspections, we look into some aspects that might seem insignificant, e. g., the organization of logistics or the general impression of the enterprise.

The first inspection is a platform for building future constructive relationships between the company and the inspectorate. Therefore, we conduct pre-audits, train manufacturers on how to save resources, improve approaches, and take into account all regulatory aspects.

I think another aspect is important: Russian companies often fail to develop a clear understanding of why they need to expand abroad. Russian pharmaceutical manufacturers often lack some necessary knowledge, general understanding, and appropriate coordination of actions and projects within the company.

We sometimes ask our customers: “Why do you need a European GMP certificate? To register the drug in Europe or to enter other export markets where this certificate is recognized?” Sometimes our customer, who is responsible for quality management in production, does not understand the international strategy of the enterprise.

Nevertheless, we must admit that Russian manufacturers have come a long way and are improving their quality control systems by leaps and bounds. The Russian Ministry of Industry and Trade and the State Institute of Medicines and Good Practices made a great contribution to this.

Pharmaceutical enterprises should stop being afraid of world markets: they should clearly define their commercial goals and interests and enter new markets, because due to the current production volumes, the domestic market is already becoming oversaturated.

We understand the importance of developing the pharmaceutical industry in the context of achieving the national development goals of the country until 2030 defined by President Vladimir Putin,  and we believe in the export potential of Russian manufacturers and the domestic pharmaceutical market and in the success of the implementation of the Pharma 2030 strategy.