• conducts examination of administrative, pharmacological, toxicological and clinical parts of registration documents of pharmacological and (or) medicinal products;
  • conducts examines and re-examines documents of pharmacological and (or) medicinal products with the involvement of independent experts;
  • decides on the use of the medicines without clinical trials in the following cases:

    • availability of information on the registration of a medical product in the manufacturer country, as well as in other countries (country);
    • availability of documents confirming the production of medicine in accordance with the requirements of GMP (good manufacturing practice) and carrying out clinical trials in accordance with the requirements of GCP (good clinical practice), the introduction of a pharmacovigilance system — GVP (good pharmacovigilance practice), as well as for medical immunobiological drugs — prequalification of the drug by WHO;

  • decides to conduct clinical trials of pharmacological and (or) medicinal products on a person;
  • determines the types of research, approves the clinical bases for conducting clinical trials, gives recommendations for the development of a program and protocol of clinical trials and approves them;
  • Based on the submitted documents and expert opinions, submit for consideration by the Expert Council recommendations on the registration of medical products without clinical trials or with clinical studies or on refusal to register them;
  • approves and adopts instructions for medical use of medicines or the changes introduced therein;
  • carries out activity on Pharmacovigilance

Pharmacopoeia Committee

Tasks of the Pharmacopoeia Committee:

- examination of normative documents for medicines subject to registration and extension of the term of registration;
- systematic revision of normative documents for medicines with a view to improving their quality and improving the methods of control;
- examination and preparation for approval of additions and amendments of the...

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Department of Registration

Tasks of the Registration Department:

- after the adoption of the application for registration, conducts the initial (preliminary) examination of the application and attached registration documents and samples of medicines, medical devices and medical equipment;
- conducts appropriate correspondence with the applicant on the...

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