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A project for the registration of drugs in the EAEU based on incomplete clinical data has been prepared

11/18/2019 | drug registration

The upcoming changes in the field of drug expertise related to the creation of a common economic space of the Eurasian Economic Union were discussed in a report by Yuri Olefir, Director General of the The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products”, of  the Ministry of Health of Russia, which he reported at the conference "Modern Approaches to Drug Examination" - "RegLek" on 18th of November 2019.

Yuri Olefir recalled the main stages of the introduction of drug registration under the new rules. If before December 31, 2020, applicants have the right to choose how the registration of drugs will be carried out, then starting January 1, 2021 this will be possible only according to the new EAEU rules. Until December 31, 2025, registration dossiers of those drugs that were registered according to national rules should be brought into line with the uniform rules of the EAEU.

Speaking about the current work of the The Federal State Budgetary Institution “Scientific Centre for Expert Evaluation of Medicinal Products” of the Ministry of Health of Russia, Yuri Olefir, in particular, said:

“The number of tasks for conducting an examination has not been decreasing recently. In 2019, in the first 9 months, we not only fulfilled, but also exceeded our annual plans - by 50% for expertise on drug quality, and by 51% in terms of benefit / risk ratio for drug registration purposes. Also, this year the center worked intensively in terms of issuing permits for conducting clinical trials and examining the quality of pharmaceutical substances. The center withstands an ever-increasing load, without compromising the quality of work. In 2020, in addition to intensifying our efforts, within the framework of the EAEU rules, it is planned to change a number of national procedures related to the registration of drugs. A significant step forward can be considered a prepared project for the registration of drugs based on incomplete clinical data. This is the so-called "registration on conditions." This procedural moment significantly accelerates and facilitates the removal of drugs intended for unmet medical needs. Similar procedures are already used in the USA, in the EU countries, in Japan. A similar acceleration of registration at the final stages of clinical trials is also provided for in the EAEU rules. ”

Next year, the “Scientific Center for Expertise in Medical Application” will have to carry out a huge amount of work on the assessment of drug interchangeability, in accordance with the new approaches outlined in the draft submitted for public discussion. At this stage, the center evaluated groups of drugs that make up less than half of the state register of medicines, and in the near future this list should increase to almost 100% of all drugs. There is a procedure for generating requests to obtain from the developers the results of clinical trials necessary to assess interchangeability. An important point of the bill is the return to the domestic regulatory framework of the international term of the original drug.

“It is worth saying that in general, the range of expert work of our center is expanding dramatically. We expect that in the coming years the volume of research expertise and its varieties will increase significantly. The expert units will simultaneously carry out the following types of work: examination of the dossier for circulation of EAEU drugs that require bringing it into line with the EAEU rules, as well as examination when registering drugs according to the EAEU procedures and examination when making variations, which so far is carried out only within the framework of national procedures. It is important to say that this is a new type of work that takes into account the best international practices, and above all the European Medical Agency, ”said Yuri Olefir.

Obviously, scientific expertise will become an important part of the formation of a single EAEU market, because this is a large-scale process that affects the interests of all participants in the pharmaceutical industry.

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