Chương V Thông tư 44/2014/TT-BYT: Tổ chức, hoạt động của chuyên gia thẩm định và hội đồng tư vấn cấp số đăng ký lưu hành thuốc

Chapter V

ORGANIZATION AND OPERATION OF ASSESSMENT EXPERTS AND ADVISORY COUNCIL FOR DRUG REGISTRATION NUMBERS

Article 35. Organization and operation of Advisory council for drug registration numbers

1. The Ministry of Health shall set up the Advisory council for drug registration numbers (including IVD products).

2. The Advisory council for drug registration numbers shall advise the Minister of Health about the issuance of drug registration numbers in Vietnam; policies on harmonization of registration of drugs with local countries and countries in the world; policies on manufacture, import and sale of drug in Vietnam including the drug used on the Vietnamese to assess the safety and efficacy of the drug where necessary.

3. The Advisory council for drug registration numbers operates following rule below: the advice of the Advisory council for drug registration numbers must ensure legal and scientific basis and it is stated in the Minutes of the meetings of the advisory council of drug registration numbers. The Advisory council for drug registration numbers shall take responsibility to the Minister of Health for advice on drug registration.

4. The Drug Administration of Vietnam shall cooperate with Department of Medical Equipment and Health Works in advising the Minister of Health against issuance of regulations of organization and operation of the Advisory council for drug registration numbers, cooperation mechanism between the Advisory council for drug registration numbers and assessment expert group in the process of issuance of drug registration numbers.

Article 36. Organization and operation of experts and expert groups of assessment of application for drug registration

1. The Ministry of Health shall authorize the Drug Administration of Vietnam or Department of Medical Equipment and Health Works to establish expert groups of assessment of application for drug registration (hereinafter referred to as assessment expert group).

2. The assessment expert group shall advise to Drug administration of Vietnam against assessment of application for drug registration, request to issue, supplement or not issue drug registration numbers.

3. The assessment expert group operates following rule below: the advice of the Advisory council for drug registration numbers must ensure legal and scientific basis and it is stated in the Record of assessment of application for drug registration. The assessment experts shall take responsibility to the Director of the Drug Administration of Vietnam, the Director of Department of Medical Equipment and Health Works (regarding IVD products) for advice against the assessment of application for drug registration.

4. The Drug Administration of Vietnam or the Department of Medical Equipment and Health Works shall formulate and promulgate regulations on selection criteria, organization and operation of expert groups of assessment of application for drug registration; conclude contracts annually with assessment experts; assess and collect the assessment results, then send it to the Advisory council; provide training course to the assessment experts; evaluate professional qualification and adherence to regulations in order to supplement appropriate experts.