First Application for Registration of Proprietary Chinese Medicines

How to Apply

Time of application: Before proprietary Chinese medicines are placed in circulation in the Macao SAR, a Certificate of Registration of Proprietary Chinese Medicine must be obtained.

Application eligibility

1. In accordance with Article 28(1) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, natural or legal persons who manufacture proprietary Chinese medicines, either themselves or by commission, in or outside the Macao SAR, may apply for the registration of such medicines, provided they cumulatively meet the following requirements:

Must have domicile in the Macao SAR, in the case of a natural person, or be legally established in the Macao SAR, in the case of a legal person;
Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from engaging in pharmaceutical activities; in the case of a legal person, its managers and members of the administrative bodies must also meet this requirement;
Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for the registration of proprietary Chinese medicines; in the case of a legal person, its managers and members of the administrative bodies must also meet this requirement;
Must have no debts subject to compulsory collection through tax enforcement proceedings.

2. In accordance with Article 28(2) of Law No. 11/2021 “Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines”, an applicant who cumulatively meets the following requirements may apply for the registration of a proprietary Chinese medicine for the purpose of importing it for circulation in the Macao SAR, provided the medicine is already registered or has been granted a marketing authorization outside the Macao SAR:

Be the holder of a license for the import, export, and wholesale of Chinese medicines / be a firm for the import, export, and wholesale of pharmaceutical products;
Must not be subject to an ancillary penalty, ancillary sanction, or security measure that prohibits them from applying for the registration of proprietary Chinese medicines.

Documents Required

I. General Documents

1. A duly completed Application Form for Registration of Proprietary Chinese Medicines; (Click here to use the online application service)

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;
Original criminal record certificate of managers and members of the administrative bodies (purpose of application: application for registration of proprietary Chinese medicines; the application may be submitted to the Identification Services Bureau, through self-service kiosks, or via the Bureau’s website, and the certificate will be sent directly by the Bureau to the Pharmaceutical Administration Bureau);
Supporting document issued by the Financial Services Bureau proving that the applicant (legal person) has no debts subject to compulsory collection through tax enforcement proceedings.

– Natural person

Copy of identification document;
Copy of proof of address;
Original criminal record certificate (purpose of application: application for registration of proprietary Chinese medicines; the application may be submitted to the Identification Services Bureau, through self-service kiosks, or via the Bureau’s website, and the certificate will be sent directly by the Bureau to the Pharmaceutical Administration Bureau);
Supporting document issued by the Financial Services Bureau proving that the applicant has no debts subject to compulsory collection through tax enforcement proceedings.

3. Declaration or supporting document of the legitimacy to submit the registration application;

4. Samples or mock-ups of the packaging, label and package insert, if any, of the proprietary Chinese medicine;

5. Test report of the proprietary Chinese medicine issued by a proprietary Chinese medicine manufacturer or a third-party testing institution;

6. Original or certified copy of the official document of the manufacturer’s production license issued by the country or region of origin; this is not required for a proprietary Chinese medicine manufacturer licensed by the Pharmaceutical Administration Bureau;

7. In the case of contract manufacturing of a proprietary Chinese medicine, supporting document for the said contract, specifically the contract manufacturing authorization, or a draft or copy of the contract; this is not required if the contract manufacturing is authorized by the Pharmaceutical Administration Bureau;

8. For proprietary Chinese medicines manufactured outside the Macao SAR, the original or certified 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, except for proprietary Chinese medicines manufactured in Hengqin in accordance with Chief Executive Dispatch No. 191/2021;

9. If the proprietary Chinese medicine is subject to patent protection, the relevant supporting document shall be submitted; if the proprietary Chinese medicine is not subject to patent protection, the relevant declaration shall be submitted.

II. Pharmaceutical Study Data;

III. Pharmacological and Toxicological Study Data;

IV. Clinical Study Data.

Remarks/Notes to Application

1. Proprietary Chinese medicines with identical names and identical formulas shall submit:

General documents;
Pharmaceutical Study Data.

2. Compound Preparations of Traditional Chinese Medicine Originating from Ancient Classical Formulas shall submit:

General documents;
Pharmaceutical Study Data;
Non-clinical safety study data.

3. Improved New Medicines and Innovative Medicines shall submit:

General documents;
Pharmaceutical Study Data;
Pharmacological and Toxicological Study Data;
Clinical Study Data.

The Pharmaceutical Administration Bureau may, according to the actual needs of the review and approval of the registration application, require the applicant to submit other information regarding the quality standards, efficacy, and safety of the proprietary Chinese medicine within a specified period.

For Improved New Medicines and Innovative Medicines, the registration application dossier submitted shall include a technical assessment opinion report issued by a third-party technical review institution.
(The third-party technical review institutions include the Macao Institute for Translational Medicine and Innovation of the University of Macau and the Centre for Pharmaceutical Regulatory Sciences of the University of Macau.)

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

MOP550.00, including stamp duty, to be paid in full upon submission of the application.

Note: In accordance with Article 78(2) of Administrative Regulation No. 46/2021, “paid fees will not be refunded if the application is not accepted, is rejected, or the dossier is filed.”

Application Processing Time

Depending on the registration category, a decision on the registration application shall be made within the following periods from the date of receipt of the application and all information required for review and approval:

Proprietary Chinese medicines with identical names and identical formulas: 60 days;
Compound Preparations of Traditional Chinese Medicine Originating from Ancient Classical Formulas: 90 days;
Improved New Medicines: 120 days;
Innovative Medicines: 240 days.