1. Drug law: 105/ 2016/QH13, effective from 1-Jan-2017
- Provide the state policy on pharmacy and the development of pharmaceutical industry, pharmacy practice; pharmaceutical business operations; registration, marketing, recall of drugs, drug raw materials; medicinal materials; drug prescriptions and drug usage; information provision on drugs, pharmacovigilance and drug advertisement; clinical pharmacy; management of drugs in medical exam, treatment establishments; clinical trial on drugs; and drug bioequivalence study; drug quality management, drug raw material & the regulation of drug price.
2. Decree: 54/2017/ND-CP, effective from 1-Jul-2017 & Decree 155, Circular 29/2020
- Provide pharmacy practice certificate; pharmacy business; export and import of drugs; registration of herbal ingredients, excipients, soft-gel shells; assessment of overseas drug manufacturers; power, method and procedures for recalling medicinal ingredients; handling of recalled medicinal ingredients; documents and procedures for issuance of certification of drug advertisement & drug price management.
3. Drug registration circular:
- Current circular: 08/2022/TT-BYT , effective from 5-Sept-2022
- Provide the guideline on human drug registration (chemical drug products, vaccines, biological products, herbal medicines) & drug materials registration (active ingredients, semi-finished products, excipients, capsules), requirements on clinical data including in the registration dossier, criteria for exemption of full or partial of clinical trial in Vietnam, requirement for products to be performed the stage IV clinical trial in Vietnam, registration process in Vietnam.
4. Other related regulations:
- Labelling circular: 01/2018/TT-BYT, effective from 1-Jun-2018: guideline on the requirements of drug labelling & package insert & decree 43/2017
- Quality circular: 11/2018/TT-BYT, effective 20-Jun-2018; Guideline on application the drug specification (chemical drug products, vaccines, biological products, herbal medicines) & drug materials (except herbal materials), Drug quality control & recall processes
- BE guideline Circular 07/2022, GMP guideline….
5. Food supplement, Medical device and Cosmetic:
- Food supplement: Registration guideline Decree 15/2018 & GMP guideline circular 18/2019
- Cosmetic: Circular 06/2016 on registration, decision 1907 & circular 29/2020
- Medical device: Decree 98/2021 on registration
