Currently, under the national registration procedure, drugs can be divided into three groups: original, generic and immunobiological medicines. However, the time makes its adjustments, and the former classification can no longer take into account all the peculiarities of medicinal products on the market. In this regard, a new classification for registration purposes has been proposed according to the rules of the EAEU, which will be considered in this article.

Figure 1 1. Classification of medicines from the position of the Regulatory Affairs Specialist (according to D.A. Rozhdestvenskiy).

Figure 1 presents a classification of medicines based on key characteristics that are relevant in the registration of drugs.

It is obvious that two groups of medicines were added — hybrid and “Grandma-Drugs”.

According to Decision 78 hybrid (“innovative” ) is a drug that does not fall within the definition of generic medicine;  It’s impossible to confirm its bioequivalence through bioavailability studies, and  changes in the current substance (s), indications for use, dosage, medicinal form or route of administration compared to the original preparation have occurred in the drug;

For such drugs in the registration dossier, it is necessary to provide:

1. The official letter from the quality authorized representative confirming that the quantity and production of the drug under study is identical to the quantitative composition and production of the medicine declared for registration.

In addition, for example, in case of replacement of excipients, it is also necessary to prepare:

2. Risk assessment associated with substitution of excipient(s).
3. Proportionality assessment for quality composition and preservation of proportionality excipient dosing.

Decision No. 85 (Annex 4, paragraph 19) established the Recommended criteria for establishing high comparability of the medicine by the quantitative composition of excipients.

Consideration of individual hybrid drugs within the framework of registration under the rules of the EAEU – info@beawire.com.

As for the so-called “Grandma-Drugs”, these include medicines with well-studied use — the efficacy and safety of the molecule are recognized on the basis of post-registration or epidemiological clinical trials, the experience of handling is more than 10 years in at least 3 States.

These include drugs from raw materials of natural origin, vitamins and mineral complexes, medicines with BAS of natural origin as an active component, solutions of antiseptics (peroxide hydrogen), water for injection, adsorbents (charcoal activated).

In order to confirm the good study of such drugs, the following information should be included in the registration dossier:

1. The period during which the active substance is used in medical practice;
2. Quantitative aspects of active substance use;
3. Frequency of scientific publications and relevance of use of active substance within 5 years prior to the date of application for registration of this drug (with reference to publications in scientific sources);
4. Consistency of scientific assessments.

The period of time required to determine the well-studied medical use of the active substance should be at least 10 years from the date of its documented use as a minimum of 3 Member States.

References:

1. Decision of the Council of the Eurasian Economic Commission of 03.11.2016 N 78 (ed. 30.01.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use”
2. Decision of the Council of the Eurasian Economic Commission of 03.11.2016 N 85 “On approval of the Rules for conducting research of bioequivalence of medicines within the framework of the Eurasian Economic Economic Commission union”
3. https://roszdravnadzor.gov.ru/i/upload/files/%d0%9e%20%d1%81%d0%bb%d1%83%d0%b6%d0%b1%d0%b5/%d0%9a%d0%be%d0%bd%d1%84%d0%b5%d1%80%d0%b5%d0%bd%d1%86%d0%b8%d0%b8%20%d0%b8%20%d1%81%d0%b5%d0%bc%d0%b8%d0%bd%d0%b0%d1%80%d1%8b/21.05.2019-%d0%a4%d0%b0%d1%80%d0%bc%d0%9c%d0%b5%d0%b4%d0%9e%d0%b1%d1%80%d0%b0%d1%89%d0%b5%d0%bd%d0%b8%d0%b5-2019/21.05%20%d0%9a%d0%be%d0%bd%d0%b3%d1%80%d0%b5%d1%81%d1%81%20%d0%b7%d0%b0%d0%bb%201%2013.00-17.00/%d0%a0%d0%be%d0%b6%d0%b4%d0%b5%d1%81%d1%82%d0%b2%d0%b5%d0%bd%d1%81%d0%ba%d0%b8%d0%b9%20%d0%94.%d0%90..pdf