Frequently asked questions
- What proprietary Chinese medicines are not subject to the registration regime for proprietary Chinese medicines?
- What is the difference between authorization and registration of proprietary Chinese medicines?
- Why do proprietary Chinese medicines specially prepared according to a prescription not require authorization from the Pharmaceutical Administration Bureau?
1. What proprietary Chinese medicines are not subject to the registration regime for proprietary Chinese medicines?
In accordance with Article 26(2) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, the registration regime for proprietary Chinese medicines does not apply to the following proprietary Chinese medicines:
- Proprietary Chinese medicines whose manufacture or import is ordered or authorized by the regulatory entity to respond to public health emergencies and medicine shortages;
- Proprietary Chinese medicines specially prepared according to a prescription;
- Hospital preparations authorized by the regulatory entity;
- Proprietary Chinese medicines considered necessary for the treatment or diagnosis of a specific pathology in a particular patient, based on clinical justification from a licensed Traditional Chinese Medicine doctor or Master of Traditional Chinese Medicine and with the authorization of the regulatory entity;
- Proprietary Chinese medicines intended exclusively for research and clinical trials;
- Samples of proprietary Chinese medicines intended for the preparation of the registration dossier.
2. What is the difference between authorization and registration of proprietary Chinese medicines?
For the registration of proprietary Chinese medicines, the applicant must submit registration documents, such as general documents, Pharmaceutical Study Data, Pharmacological and Toxicological Study Data, and Clinical Study Data. After review and approval by the Pharmaceutical Administration Bureau, a Certificate of Registration of Proprietary Chinese Medicine will be issued, and the relevant proprietary Chinese medicine may be placed in circulation in the Macao market.
Authorization of proprietary Chinese medicines applies to the special situations provided in Article 26(2) of the “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, including:
- Proprietary Chinese medicines whose manufacture or import is ordered or authorized by the regulatory entity to respond to public health emergencies and medicine shortages;
- Hospital preparations authorized by the regulatory entity;
- Proprietary Chinese medicines considered necessary for the treatment or diagnosis of a specific pathology in a particular patient, based on clinical justification from a licensed Traditional Chinese Medicine doctor or Master of Traditional Chinese Medicine and with the authorization of the regulatory entity;
- Proprietary Chinese medicines intended exclusively for research and clinical trials;
- Samples of proprietary Chinese medicines intended for the preparation of the registration dossier.
The import and use of the above-mentioned proprietary Chinese medicines must obtain prior authorization from the Pharmaceutical Administration Bureau. At the same time, they may not be placed in circulation in the Macao market and may only be used for specific patients or under specific circumstances.
3. Why do proprietary Chinese medicines specially prepared according to a prescription not require authorization from the Pharmaceutical Administration Bureau?
Proprietary Chinese medicines specially prepared according to a prescription refer to proprietary Chinese medicines prepared according to a prescription issued by a Traditional Chinese Medicine doctor or Master of Traditional Chinese Medicine licensed to practise in Macao, in a Chinese pharmacy, a healthcare service establishment where such practitioner provides Traditional Chinese Medicine services, or a proprietary Chinese medicine manufacturer, and supplied to specific types of patients. Proprietary Chinese medicines specially prepared according to a prescription form part of the provision of healthcare services and therefore do not require authorization from the Pharmaceutical Administration Bureau. However, the Traditional Chinese Medicine doctor or Master of Traditional Chinese Medicine using such proprietary Chinese medicine shall be responsible for its safety and adverse reaction monitoring.