On October 8, 2026, the National Medical Products Administration (NMPA) issued the Announcement on Strengthening the Protection of Traditional Chinese Medicine Varieties (Announcement No. 97 of 2026). The previous systematic document on TCM variety protection was the 2009 Guidance on the Protection of Traditional Chinese Medicine Varieties (Document No. 57). More than ten years have passed since then. During this period, the Drug Administration Law was comprehensively revised, the MAH system was implemented, the Measures for Drug Registration was updated, and new regulatory documents including the Classification and Submission Requirements for TCM Registration and the Special Provisions for the Administration of TCM Registration were released, bringing profound changes to the TCM regulatory system.
This announcement is not an amendment to the Regulations on the Protection of Traditional Chinese Medicine Varieties. The Regulations, implemented in 1993 and slightly revised in 2018, are still the valid framework. The 2022 draft for public comment has not been formally promulgated. Essentially, this announcement serves as a procedural transition document before the revised Regulations are finalized. It establishes operational rules covering application, inspection, technical review and objection handling to align with the current regulatory regime.
It is critical to clarify the applicable scope of this announcement.
The announcement specifies at the end: After the issuance of this announcement, where the original Notice on Issuing the Guidance on the Protection of Traditional Chinese Medicine Varieties (Guo Shi Yao Jian Zhu〔2009〕No.57) conflicts with this announcement, the provisions of this announcement shall prevail. Matters not covered by this announcement shall still follow the original provisions.
Accordingly, Document No.57 has NOT been repealed. Its relevant standards and technical requirements remain effective. The adjustments in this announcement mainly focus on procedural matters.
The above revisions reflect three major adjustments. First, procedures become more stringent: one-time notification and one-time submission of supplementary data with clear deadlines. Second, the responsible entity aligns with the MAH system, and rules for inspection scope and site selection are more transparent. Third, registration applications for same-name same-formula TCM are rejected during the protection period, substantially strengthening the protection barrier.
Given that applicants only get one chance to submit supplementary materials within 80 working days, cross-departmental pre-review by pharmaceutical, clinical, regulatory and pharmacovigilance teams is recommended before formal submission. Focus shall be placed on post-marketing clinical data, traceability of process changes and completeness of adverse reaction data to resolve risks in advance.
The announcement formalizes the pre-application communication channel. For varieties with process improvement, standard upgrading or historical data defects, enterprises shall prepare a list of core questions and apply for communication proactively. Clarify document requirements before investing in R&D to avoid ineffective expenditure.
Comprehensive screening shall be performed prior to application. The following types of varieties require careful evaluation or deferred submission: Varieties with questionable data integrity:
----especially early-listed products with complicated historical records, such as incomplete batch records for process changes, lost original research data or untraceable reference standards, which are highly likely to fail inspection.
----Varieties that cannot meet clinical site inspection requirements: the announcement mandates inspection covering the lead site and at least two representative sites. Applications face high rejection risks if the original clinical institution has been deregistered, source medical records are lost or principal investigators cannot be contacted.
----Varieties with unclear MAH ownership: since applicants must be MAHs, varieties involving commissioned production, co-ownership, ownership disputes or ongoing MAH transfer shall resolve ownership issues first to avoid rejection after acceptance.
----Varieties whose market value cannot cover costs: TCM variety protection requires investment in R&D, inspection and filing. Cost-benefit evaluation shall be carried out based on product lifecycle, market scale and competitive landscape.
In addition, re-assess strategies for same-name same-formula TCM products in the pipeline. For varieties with the first holder already approved or under public notice, evaluate whether follow-up protection application is worthwhile. For accepted but unapproved same-name same-formula TCM, arrange timeline properly: apply for protection right after approval, with the same expiry date as the first protected variety.
In summary, this announcement refines the previously loose procedural rules for TCM variety protection. Enterprises shall start with variety screening, base submissions on document compliance and make use of the communication mechanism to cope with the increasingly stringent review requirements.
With a professional and efficient service system and a comprehensive operational network, Guangzhou Evidence Based Medicine is committed to providing tailored one-stop traditional Chinese medicine research and development full industry chain service solutions for every customer, promoting traditional Chinese medicine to the world and safeguarding the health of more people.
