WTO技术性贸易措施服务平台（商务部应对贸易摩擦工作站）

中文标题：指导药物成品和药物成分登记的通知草案；（529页，越南语）

英文标题：Draft Circular guiding the registration of drugs and pharmaceutical ingredients; (529 page(s), in Vietnamese)

覆盖产品：Medicinal finished products and medicinal ingredients

内容概述：This draft Circular details:a) Documentation requirements, procedures for issuance, renewal, revision and revocation of the marketing authorization of modern medicines, vaccines, biologicals, herbal drugs and medicinal materials (including active ingredients, semi-finished herbal ingredients, excipients, and capsule shells) for human use in Vietnam;b) Required clinical data for assurance of safety and efficacy in the application;c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;d) Rules for validation of marketing authorization applications (hereinafter referred to as "marketing application") for drugs/medicinal materials, renewal and revision thereof;d) Rules for validation of applications for licenses to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as "unapproved drugs") in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on business conditions under state management of the Ministry of Health of Vietnam (hereinafter referred to as "Decree No. 155/2018/ND-CP");g) Rules for the organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as "the Advisory Board");h) Organizing and operating principles of the Advisory Council for the issuance of marketing authorization of drugs and pharmaceutical ingredients (hereinafter referred to as the Council)