Drug registration is a comprehensive, complex process that requires compliance with a large number of requirements and regulations. Fundamental principles of this process are reflected in the documents of the Eurasian Economic Commission. If you know all the regulatory issues and the nuances of drug registration procedures, you can develop a correct and effective strategy, without which the process of obtaining a registration certificate (RF) is impossible.
The main document to be guided in the development of the strategy is the Decision of the EEC Council № 78 of 03.11.2016 “On the Rules for Registration and Examination of Drugs for Medical Use”. It establishes the principles, procedure, terms of registration and examination of medicinal drugs, as well as the terms of circulation of medicinal drugs in the EAEU member states. And it includes information on the requirements for the registration dossier: the description of modules, forms of applications, reports, and other documents required for the registration of drugs.
The main stages, which have the most important strategic importance in the preparation of the registration dossier.
1.A description of the drug to be registered.
The strategy should begin with defining the registration group of the drug. By Annex 1 to the Registration Rules, the drug can be classified as original, reproduced, hybrid, bio-analog, or other groups. The classification determines the format of the submitted dossier and the entire subsequent strategy.
2. Choice of registration mechanism.
There are two mechanisms for state registration within the common market of the EEC.
Mutual recognition procedure. Registration is carried out only in one chosen EEC member-state (the reference state), with the possibility of further recognition in other EEC member-states at the request of the applicant.
Decentralized procedure. Registration is carried out simultaneously by several member-states, with the choice of the reference state.
3. Determination of the amount of data in the dossier.
It is necessary to provide information about all life cycles of the drug: scientific research, preclinical development, clinical development, pharmaceutical development, and manufacturing processes to obtain the RF.
4. Conducting research.
Our next step is to develop a plan for ongoing preclinical and clinical studies. Up-to-date documentation describing the requirements for conducting clinical trials can be found on the website of the Eurasian Economic Commission.
A correctly made strategy will allow: to make a plan of actions, determine the terms of all necessary stages in the preparation of the registration dossier, save the money, and successfully, with minimal costs, go through the registration of the medicinal product.
Our specialists have experience in this area and will be happy to help you develop a registration strategy for your drug