Interview of General Director Efimov K.V. published in Business of Capital. Medicine 2022.
Services for the registration and promotion of medicines in Russia and abroad
The Regafarm company has been operating in the drug registration market for almost 10 years. The experience of employees and even more - from 15 years. “The qualifications, experience and extensive social connections of our specialists allow us to provide consulting services of any complexity,” says General Director Konstantin Efimov. “Our other important advantage is that we not only register medicinal products, but also help bring them to the market.”
What is included in the list of services provided by your company at present?
We offer services for the registration of medicines and substances, we advise on issues related to individual stages of registration, with changes to registration certificates, we help in obtaining GMP certificates in accordance with the rules of the Eurasian Economic Union and bringing the dossier in accordance with the rules of the EAEU, we provide assistance in promotion of registered products.
What makes your company different from others in the same field?
It is not easy for manufacturing companies to work now. The tense situation in the economy and various changes in the rules of registration have an effect. Our company is small, we do not have the bureaucracy inherent in large organizations, so we react to such changes very quickly. Promptly solve
regulatory issues of any complexity. Here we also have many opportunities and extensive experience in various areas.
For example, my work experience in pharmaceutical companies in Russia and other countries is more than 26 years, the company's employees - from 15 years, some of them worked in state regulatory departments.
Our clients are mainly small and medium-sized companies. We provide outsourcing services to large enterprises if their specialized departments cannot cope with the current workload.
How seriously have the rules for registration of medicines changed in recent years?
Gradual changes in the rules for registration of medicines in Russia have been taking place since 2008. They are becoming more stringent and at the same time more harmonized. We believe that the legislator is moving in the right direction. He strives to ensure that only high-quality drugs enter the market. Of course, there are some questions about clinical trials, especially in relation to generics, but I think that in the near future they will be resolved.
Registration of medicines under the national procedure from January 1, 2022 is not applicable. Now all medicines are registered within the EAEU. We are confident that this procedure will soon become clear to all market participants. They will get used to it in the same way as they are used to all other procedures.
Are the current state duties of manufacturers not surprising?
Yes, of course, some of our clients are concerned about the size of state duties. They have now grown significantly. In particular, for making changes to the registration certificate, which require an examination of the medicinal product, the state duty is 490 thousand rubles. However, information has recently appeared that the fees in the field of registration of medicines will be revised downward.
What are the nuances associated with the new rules that companies registering medicines should pay attention to?
Recently, calls from representatives of the Ministry of Health, the Ministry of Industry and Trade, the SID and NP Institute, and other regulatory agencies have been heard from all tribunes to make more active changes to registration certificates and bring the dossiers in line with the rules of the EAEU. The fact is that all national marketing authorizations that have been issued expire on January 1, 2026.
We have the following statistics. According to the Eurasian Economic Commission, for the period from January 1 to August 19, 2022, 918 applications for registration of medicines and 1,730 applications for bringing the dossier in accordance with the rules of the EAEU were accepted in the Russian Federation. A total of 17,785 medicines are registered according to national requirements. Accordingly, even if half of this number simultaneously goes for re-registration in accordance with the requirements of the EAEU, the Ministry of Health, Roszdravnadzor, expert organizations will not be able to cope with such a flow of applications. The result may be a decrease in the range of medicines in pharmacies and medical institutions and a decrease in business income.
Drug manufacturers are making a big mistake when they think that if they apply for changes in 2025, they will have time to pass the procedure.
Therefore, we encourage all our clients not only to start preparing for the change of dossier, but to already submit applications.
Is making changes to the dossier a complicated procedure?
Yes, this procedure is very difficult. First, the requirements of the EAEU differ for different groups of drugs. In addition, in the process of making changes, various issues may arise, the solution of which will take time. For example, regarding the list of indications for the use of this product, as a result of which it may be necessary to change the methods of conducting research to form a list of indications. If the methodology is not changed, some important indication will have to be excluded from the dossier, which may lead to a decrease in sales.
You also provide registration services for substances. What are the features here?
As for substances, the situation is not very clear at the moment. Firstly, they were not registered as such before. They were included in the State Register of Medicines. Applications were submitted by trading companies that sold these substances to the drug manufacturer. According to the rules of the national procedure, which is no longer working, it was possible to make changes to the information about the substance in the City Register. For example, a drug manufacturer could switch from one supplier of a substance to another if it had a supply problem. The drug manufacturer could also choose any substance included in the State Register of Medicines.
Now an application for registration of a substance is submitted as part of a dossier. There are no clear rules within the EAEU for this procedure, but we hope that they will be formed. In the meantime, we recommend traders who sell substances to a large number of clients (and the need for them is very high, because Western suppliers of substances are leaving the market) to apply according to the old procedure, that is, to enter the substance in the State Register, so that later there were problems with sales.
As part of this area, we also provide a service for obtaining a GMP certificate for a foreign substance. It is required in accordance with the rules of the EAEU for its inclusion in the State Register of Medicines. Meanwhile, this procedure costs a lot of money.
The company's website says that you offer comprehensive solutions for bringing medicines to the markets not only in Russia, but also in Europe and Asia. How does it work in the current economic climate?
Complex solutions are another important difference of our company. There are many companies on the market that provide services for the registration of medicines. We do more: we not only register the product, but also provide qualified assistance in its promotion. We bring foreign drugs to the Russian market, Russian drugs to the markets of other countries.
The specialists of our company have all the competencies required for this.
When a client comes to us with a list of products they intend to register, we perform a full analysis of their portfolio. We talk about what products will be in demand, what problems may arise. In other words, we provide a full range of consulting services for bringing a product to the Russian market.
If we are promoting a Russian drug on foreign markets, we turn to our German partner, with whom we have developed a trusting relationship over the years of working together and gained extensive experience in successful cooperation. At our request, he will provide the necessary monitoring information about the situation on the market, provide a service for obtaining a GMP certificate valid in the EU countries or in Asian countries.
If the client wishes, we will help him draw up a marketing plan, we will find a company that will closely promote his product.
You also provide business development services. This direction, probably, has something in common with services for the promotion of medicines?
Yes, definitely. Also within the framework of this direction we find clients or partners abroad for Russian companies, which is especially important in the current economic conditions. These are mainly Indian or Chinese enterprises. They offer their products either as contract manufacturers, or release them under license, or as part of an exclusive collaboration format. Accordingly, Russian partners, with our help, register these drugs and organize their sales in Russia. Recently, with our participation, a contract was signed under which a Russian pharmaceutical company will sell under its own brand 13 generics imported from India.
In order to develop this direction, we participate in various exhibitions, try on certain products. The quality of the offered products, even imported ones, does not always meet the registration requirements under the EAEU procedure. And if the quality of the drug is not confirmed during the examination, it will not be possible to register it.
What services do you provide as part of the organization of clinical trials?
We organize any preclinical and clinical studies. We guarantee that they will be carried out at a high quality level in accordance with applicable rules and regulations. Our prices are quite democratic in comparison with many other organizations offering similar services.
What is the main thing in your work?
In one word, quality. We do not strive to increase the number of clients, we do not divide them into priority and not so. Regardless of the scope of the agreed work, each customer is unique for us, all our specialists work with each, using all their knowledge, skills, skills and experience.
By the quality of service, we also understand the efficiency of feedback. In our company, the speed of processing client requests is one of the priorities. Long coordination and bureaucratic procedures are not about us. We do our best to ensure that our customers are always satisfied with cooperation with our company and we take on the most difficult cases in the field of regulation.