How to Apply
Time of application: Prior authorization from the Pharmaceutical Administration Bureau must be obtained before conducting clinical trials of Improved New Medicines or Innovative Medicines in the Macao SAR.
Application eligibility:
- Applicant:
- Must have domicile in the Macao SAR, in the case of a natural person;
- Must be legally established in the Macao SAR, in the case of a legal person.
2. The clinical trial institution must comply with the requirements of Good Clinical Practice (GCP).
Documents Required
1. A duly completed Application Form for Prior Authorization to Conduct Clinical Trials;
2. Documents relating to the applicant:
• Legal person
– Original commercial registration certificate issued by the Commercial and Movable Property Registry (exempted if the company has already been registered with the Commercial and Movable Property Registry);
– Copies of identification documents of managers and members of the administrative bodies.
• Natural person
– Copy of identification document;
– Copy of proof of address.
3. Declaration or supporting document of the legitimacy to submit the application for prior authorization to conduct clinical trials;
4. Declaration or supporting document proving that the clinical trial institution is qualified to conduct clinical trials;
5. Supporting document proving that the manufacturing process of the investigational proprietary Chinese medicine involved in the clinical trial complies with the quality management requirements for manufacturing;
6. General documents, Pharmaceutical Study Data, and Pharmacological and Toxicological Study Data of the investigational proprietary Chinese medicine involved in the clinical trial;
7. Samples of the packaging, label and package insert of the investigational proprietary Chinese medicine involved in the clinical trial;
8. Study background document of the investigational proprietary Chinese medicine involved in the clinical trial;
9. Clinical trial protocol;
10. Investigator’s Brochure;
11. Statistical Analysis Plan;
12. Informed consent form template for trial subjects;
13. Documents relating to the composition and operation of the Ethics Committee of the clinical trial institution concerned.
Location of Application and Service Hours
Location of application: Pharmaceutical Administration Bureau – Department of Registration – Division of Traditional Chinese Medicines
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 the prior authorization to conduct clinical trials to the applicant.
Relevant Regulations or Requirements
Application Status Enquiry and Result Collection
Method of result collection: In person