Related legislations
- Law No. 11/2021 - Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines
- Administrative Regulation No. 46/2021 - Implementing Regulations for the Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines
- Technical Instruction No. 20/ISAF/2022 - Technical Requirements for the Registration Dossier of Proprietary Chinese Medicines
- Technical Instruction No. 21/ISAF/2022 - Technical Requirements for the Registration Dossier of Compound Preparations of Traditional Chinese Medicine Originating from Ancient Classical Formulas
- Technical Instruction No. 23/ISAF/2022 - Norms for Limits of Heavy Metals, Toxic Elements, Microbial Contaminants, and Pesticide Residues in Proprietary Chinese Medicines
- Technical Instruction No. 24/ISAF/2022 - Technical Specifications for the Registration of Bovine-Derived Proprietary Chinese Medicines
- Technical Instruction No. 25/ISAF/2022 - Naming Rules and Technical Requirements for the Packaging, Labeling, and Package Insert of Proprietary Chinese Medicines
- Technical Instruction No. 28/ISAF/2022 - Technical Requirements for Clinical Trial Applications
- Technical Instruction No. 29/ISAF/2022 - Technical Requirements for Changes to Registered Information of Proprietary Chinese Medicines
- Technical Instruction No. 30/ISAF/2022 - Preparation and Technical Requirements of Information for the Renewal of Registration of Proprietary Chinese Medicines
- Technical Instruction No. 15/ISAF/2022 - Identification Criteria for Proprietary Chinese Medicines, Chinese Medicinal Materials, and their Prepared Decoction Pieces that Require a Prescription
- Chief Executive Dispatch No. 189/2021 - Approves the models for the license for manufacturing Chinese medicines, license for import, export, and wholesale of Chinese medicines, license for Chinese pharmacies, the corresponding provisional licenses, and the certificates for registration of proprietary Chinese medicines and natural medicines.
- Chief Executive Dispatch No. 190/2021 -Approves the “Table of Fees for Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”
- Chief Executive Dispatch No. 191/2021 - Stipulates that for proprietary Chinese medicines manufactured in Hengqin, the application for registration or renewal is not required to be accompanied by a certificate of registration or sale issued by the competent authorities of the country or region of origin or provenance.
- Dispatch of the Secretary for Social Affairs and Culture No. 95/2021 -Approves the “Table of Chinese Medicinal Materials Used in the Macao Special Administrative Region”