INTRODUCTION

Universal health coverage will help achieve the UN Sustainable Development Goals by 2030 and fulfill the main goal of the WHO Charter “The human right to health”. To do this, it is necessary to strengthen primary health care and ensure everyone’s access to effective drugs and vaccines, medical devices. The article presents an overview of existing effective strategies for registration of medicines and vaccines.

DRUG GOOD REGISTRATION MANAGEMENT

Effective strategies for good registration management medicines are developed in accordance with national or regional principles approved by the relevant regulatory authorities. The drugs and vaccines registration process consists of two processes described in the basic document “Good Registration Management”: the preparation and submission of documents (Good Submission Practices) for a specific drug or vaccine and the review process (examination, verification) of the submitted documents (Good Review Practices). The principles of effective management of registration of drugs and vaccines are being discussed at the WHO International Conference of Drug Regulatory Authorities. The Conference is a platform for meetings and discussions, mechanisms for strengthening cooperation and reaching consensus in determining priorities for actions in the field of national, regional and international regulation of the production, registration and circulation of drugs and vaccines.

CONCLUSION

Modern local, regional and global changes faced by regulatory authorities responsible for the registration of medical products are: the expansion of the free trade zone and the market, the development of treatment, diagnosis and control in healthcare advanced technologies, the widespread use of digitalization, etc. These changes require constant updating and adaptation of strategic documents for the registration and review of medical products.