How to Apply
Time of application: No relevant provisions.
Application eligibility:
1. Applicant:
- Clinical trial centres;
- Laboratories conducting research and development of pharmaceutical products;
- Applicants for registration of proprietary Chinese medicines;
- Traditional Chinese Medicine doctors;
- Masters of Traditional Chinese Medicine;
- Traditional Chinese Medicine pharmacists;
- Others.
2. The applicant shall assume responsibility for monitoring adverse reactions to proprietary Chinese medicines.
Application procedures and documents required:
- Proprietary Chinese medicines intended exclusively for research and clinical trials
- A duly completed Application Form for Authorization of Proprietary Chinese Medicines;
- Documents relating to the applicant;
- Description and supporting documents proving that the use of the proprietary Chinese medicines is exclusively for research and clinical trials;
- Quality standards and samples of the packaging, label or package insert;
- Declaration of undertaking responsibility for monitoring adverse drug reactions.
- Samples of proprietary Chinese medicines intended for the preparation of the registration dossier
- A duly completed Application Form for Authorization of Proprietary Chinese Medicines;
- Documents relating to the applicant;
- Supporting document proving that the proprietary Chinese medicine concerned is at the stage of registration application;
- Quality standards and samples of the packaging, label or package insert.
- Proprietary Chinese medicines considered necessary for specific pathologies
- A duly completed Application Form for Authorization of Proprietary Chinese Medicines;
- Documents relating to the applicant;
- Clinical justification issued by a Traditional Chinese Medicine doctor or Master of Traditional Chinese Medicine stating that the proprietary Chinese medicine is suitable for the specific pathology of a particular patient;
- Quality standards and samples of the packaging, label or package insert;
- Declaration of undertaking responsibility for monitoring adverse drug reactions;
- Original or copy of the certificate of registration or sale of the proprietary Chinese medicine issued by the competent authority of the country or region of origin, or of the country or region of provenance; if the aforementioned document is unavailable, supporting documents proving the efficacy and safety of the proprietary Chinese medicine concerned.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau
Address: Avenida do Comendador Ho Yin, Edifício de Escritórios do Governo (Qingmao), 19.º andar, Macau
Service hours:
Mondays to Thursdays: 09:00-13:00; 14:30-17:45
Fridays: 09:00-13:00; 14:30-17:30
Closed on Saturdays, Sundays and public holidays
Fees
No fee is required.
Application Processing Time
The review and approval of the application dossier will be completed within 90 days from the date of receipt of all required application documents. If the application is approved, the Pharmaceutical Administration Bureau will issue an authorization certificate to the applicant.
Relevant Regulations or Requirements
Application Status Enquiry and Result Collection
Method of result collection: In person