Registration of Traditional Chinese Medicine

1. What are the registration categories for proprietary Chinese medicines?

The registration categories for proprietary Chinese medicines include:

• Proprietary Chinese medicines with identical names and identical formulas;
• Compound Preparations of Traditional Chinese Medicine Originating from Ancient Classical Formulas;
• Improved New Medicines;
• Innovative Medicines.

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2. What information is required for an application for registration of proprietary Chinese medicines?

The application dossier for registration of proprietary Chinese medicines includes general documents, pharmaceutical study data, pharmacological and toxicological study data, and clinical study data. The information required for applications of different registration categories is as follows:

• Proprietary Chinese medicines with identical names and identical formulas: general documents and pharmaceutical study data shall be submitted;
• Compound Preparations of Traditional Chinese Medicine Originating from Ancient Classical Formulas: general documents, pharmaceutical study data and non-clinical safety study data shall be submitted;
• Improved New Medicines and Innovative Medicines: general documents, pharmaceutical study data, pharmacological and toxicological study data, and clinical study data shall be submitted.

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, efficacy, and safety of the proprietary Chinese medicine within a specified period.

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3. How long does it take to review and approve the registration of proprietary Chinese medicines?

Taking into account the nature of different registration categories, the Pharmaceutical Administration Bureau will make a decision within the following periods from the date on which all information required for review and approval is complete:

• 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.

Based on the complexity of the application or other reasonable grounds, the Director of the Pharmaceutical Administration Bureau may exceptionally authorise an extension of the periods specified in the preceding paragraph by up to 60 days, and shall notify the applicant before the expiry of the original period.

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4. How long is the registration of proprietary Chinese medicines valid?

The registration of proprietary Chinese medicines is valid for five years and may be renewed for successive periods of the same duration. For the first registration renewal of Improved New Medicines and Innovative Medicines, the registration holder shall submit to the Pharmaceutical Administration Bureau a report proving that the relevant proprietary Chinese medicine has passed efficacy and stability tests during the registration’s validity period.

The application for renewal of registration of proprietary Chinese medicines must be submitted by the registration holder at least 90 days before the expiry of the registration’s validity period; otherwise, the registration holder shall bear responsibility for the registration not being renewed after its expiry, including removing the relevant proprietary Chinese medicine from shelves during the period from the expiry of validity until the renewal is approved.

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5. What are the fees for the various applications relating to registration of proprietary Chinese medicines?

Registration Authorization

Proprietary Chinese medicines: MOP500

Registration Renewal

Proprietary Chinese medicines: MOP200

Re-issuance of Registration Certificate: MOP200

Changes to Registered Information (fee is charged per item of information to be changed; for related changes, all involved items are calculated as a single item): MOP100

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