26 July 2018/ECE expands a single regulatory framework for the work of the Union of medicines and medicines markets
To ensure the uniformity of mandatory requirements for the safety, efficacy and quality of medicines and medical products in the Eurasian Economic Union (EEMP), the working groups formed at the College of the Eurasian Economic Commission (ECE) agreed approaches on selected issues of circulation of medicines and medical products in the common market ЕАЭС. For the first time, the meetings of the relevant ECE working groups were held at the site of the Kyrgyz Republic.
The Working Group on Drug Administration of the Eurasian Economic Commission (ECE) approved the draft Guidelines on the Requirements for Documentation for Chemical and Pharmaceutical Quality for Study Drugs Used in Clinical Studies. In the future, the project will be placed on the official website of the Eurasian Economic Union (EAEU), and everyone will be able to send comments and suggestions.
General approaches to determining the volume of expertise of the quality of samples of medicinal products, which is necessary for the registration of the same type of drugs, are also agreed. This applies to drugs with flavor additives, as well as tests for biological products. The document will help to reduce manufacturers’ costs for duplicate tests, speed up the procedure of examination and admission of drugs to the market of the EAEC.
Representatives of the Department of Technical Regulation and Accreditation, the Legal Department of the Commission, authorized bodies and expert organizations of the EEA countries, as well as representatives of manufacturers and distributors of medicines and medical products took part in the meetings of the ECE working groups.
As the meeting participants noted, all the necessary documents for the functioning of the common union markets for medicines and medical products have already been adopted. This allows the states of the Union to start accepting applications for registration of medicines and medical products according to the rules of the EAEC. Now there is an active preparation of acts of the “third level”. The developed guidelines and recommendations on hotel issues related to the circulation of medicines and medical products are designed to harmonize the current practice of market regulation in the EEA states and are aimed at expanding the single regulatory framework.
The participants of the working group meeting on drug circulation also discussed the draft Guidelines on the formation (registration) of a registration dossier for a medicinal product in the format of a general technical document (DTD), Requirements for indicating the content of active substances or extracts from herbal medicinal raw materials in drug labeling and instructions for medical use, Guidelines for the content of the dossier of the study drug given for the purpose of clinical trials and reporting to clinical trials. This group of documents contains explanations on the formation of the dossier of the medicinal product and the methods of indicating the information on the dosage.
A number of projects related to drug research in pediatrics were also reviewed: Guidelines on the principles of extrapolation of data on efficacy and safety in the pediatric population in the development of a medicinal product, Guidelines for the clinical study of medicinal products in a pediatric population, Requirements for determining the use of a dosage form in pediatric practice or limited part of the pediatric population.
The Working Group on Medical Devices in general approved the Draft Requirements for organizations that have the right to inspect the production of medical devices for compliance with the requirements for the implementation, maintenance and evaluation of their quality management system, and, in addition, reviewed the finalized by the participants of the working group from the Russian Federation Methodological recommendations on the content and structure of the documents of the registration dossier on a medical product and the Methodological recommendations on the examination of safety
The next meeting of the working groups will be held in late August – September 2018.
Working groups on the issues of the use of medicines and medical products in the EEA have been formed at the ECE Collegium in 2012. They include representatives of the Commission, the authorized bodies of the EEA countries and the pharmaceutical business. The main task of the working groups is the development of draft Commission acts aimed at ensuring the functioning of the common markets for medicines and medical products in order to implement the Agreement on Uniform Principles and Rules for the circulation of medicines signed in December 2014 within the framework of the Eurasian Economic Union and the Agreement on Uniform Principles and rules for the circulation of medical devices (medical devices and medical equipment) within the framework of the Eurasian Economic Union .