Simplified Traditional Chinese Medicine Registration Announced for Hong Kong and Macao Manufacturers

Simplified traditional Chinese medicine registrations have been announced for Hong Kong and Macao manufacturers by China's Center for Drug Evaluation (CDE). The CDE said the simplified registrations will be effective from 2025 for traditional oral Chinese medicines produced in Hong Kong and Macao. Established under the National Medical Products Administration (NMPA) Announcement No. 7 of 2025, this initiative aims to facilitate faster entry into the mainland China market. By reducing documentation and technical requirements, the policy supports greater regulatory alignment within the Greater Bay Area.

Scope of Application

The scope of application for the measure covers:

Traditional oral Chinese medicines held by manufacturers registered in the Hong Kong and Macao Special Administrative Regions;
Traditional oral Chinese medicines approved and marketed locally for over 15 years; and
Production processes that comply with the requirements of Good Manufacturing Practice (GMP) for pharmaceuticals.

Differences Between Conventional and Simplified Marketing Applications

Compared with the Notice on the Classification of TCM Registration and Requirements for Application Documents issued by the NMPA (Notice No. 68 of 2020), we have summarized the differences in application documents between conventional and simplified marketing applications for TCM (traditional Chinese medicine). See Table 1 for details.

Table 1: Differences in Application Documents between Conventional and Simplified Marketing Applications for TCM

Type Listing Application (Regular) Listing Application (Simplified) Requirements

Administrative documents and drug information
Summary
Pharmaceutical research materials
Pharmacological and toxicological research data
Clinical research data

Administrative documents
Pharmaceutical research materials
Supporting materials, manuals and packaging labels for listing

Requirements for Simplified Application Documents

Administrative Documents

Only 10 documents are required: "Explanation letter, application form, application materials for the approval of the generic name of the drug, inspection-related information, supporting documents, patent information, proof of qualification of the research institution, proof of permission for the drug to be marketed and sold, proof of qualification of the applicant/manufacturer, and proof of the registration agent." This significantly reduces the time and cost for applicants to prepare application documents.

Pharmaceutical Data

Prescription and Herbal Resource Assessment: The quality standards of the herbal materials used in the decoctions should be provided, specifying the origin, medicinal parts, place of production, harvesting period, and whether the herbs are cultivated or wild. For multi-origin herbs, the origin should be fixed. The consistency of the above information of the herbal materials used in the application product with those of the products approved and registered in Hong Kong and Macao should be emphasized.
Decoction Processing: The quality standards of the decoctions should be provided, specifying the processing methods and technological parameters of the decoctions. The consistency of the processing technology of the decoctions used in the application product with those of the products approved and registered in Hong Kong and Macao should be emphasized.
Preparation Process: Traditional oral Chinese medicines should be prepared using traditional processes, and a "Traditional Chinese Medicine Production Process" document should be provided. This should specify the preparation process route, dosage form, and raw and auxiliary materials, as well as the main technological parameters and ranges for each process step, such as pre-treatment of prescription ingredients, extraction and separation processes, concentration processes, drying processes, and formulation processes. The consistency of the preparation process of the application product with those of the products approved and registered in Hong Kong and Macao should be emphasized.
Quality and Quality Standards of Preparations: The quality re-inspection reports of three batches of samples can be issued by the Guangdong Provincial Institute for Drug Control, which shortens the approval cycle.
Packaging, Storage, and Shelf Life: The packaging materials and containers in direct contact with the drug, storage conditions, and shelf life should be specified, and the consistency with the products approved and registered in Hong Kong and Macao should be explained.

Marketing Support Documents, Instructions, and Packaging Labels

Clinical Aspects: For products with prescriptions, preparation methods, indications, and dosage that are consistent with those recorded in the current "Chinese Pharmacopoeia," only a clinical safety statement of the product should be provided. For other products, a rationale and safety summary should be included based on TCM theory and Hong Kong/Macao sales experience.
Pharmacological and Toxicological Aspects: Generally not required unless there are safety concerns (e.g., toxic ingredients or use in special populations).
Instructions and Packaging Labels: Provide current and draft versions for mainland registration, aligned with TCM theory and consistent with existing product labels.

Post-Market Management

Post-Market Changes: Simplified application may be used for post-market changes such as prescription or process updates. Notarization is not required.
Re-registration: Application documents should meet the standard requirements for overseas drugs. Notarization is waived under simplified policy terms.

This notice simplifies the application documents and technical requirements, reducing unnecessary repetitive work and cumbersome procedures, saving applicants' time and cost, and improving the efficiency of registration and approval. It enables traditional Chinese medicines from Hong Kong and Macao to enter the mainland market more quickly to meet patient needs. For regulatory authorities, it also optimizes resource allocation, allowing more energy and resources to be devoted to important aspects such as drug supervision and safety monitoring, ensuring public drug safety.

Further Information

To read the original announcement about the simplified registration pathway for traditional Chinese medicines from Hong Kong and Macao released by the Center for Drug Evaluation under the NMPA, please click here.

If you are a traditional Chinese medicine manufacturer with questions about how long it takes or how much it costs to register your product for the China market, please contact Cisema.