Chengdu, China – 15 Sep 2026 – The Office of the Sichuan Provincial Drug Administration (Sichuan MPA) has issued a province‑wide notice soliciting drafting units for the first batch of new and revised traditional Chinese medicine (TCM) standards, formally launching the revision cycle for the Sichuan Provincial Standards for TCM Materials (2010 Edition) and the Sichuan Provincial Processing Norms for TCM Decoction Pieces (2015 Edition). The call is open to drug testing institutions, universities and research institutes, and TCM production and R&D enterprises, with applications due by 8 October 2026.
Policy Snapshot
| Item | Detail |
|---|---|
| Issuing Authority | Office of the Sichuan Provincial Drug Administration |
| Initiative | First batch of newly added and revised provincial TCM standards |
| Standards Under Revision | Sichuan Provincial Standards for TCM Materials (2010 Edition); Sichuan Provincial Processing Norms for TCM Decoction Pieces (2015 Edition) |
| Scope | Varieties listed in Attachment 1 (new additions) and Attachment 2 (revisions); number of varieties not disclosed in the notice body |
| Eligible Applicants | Independently incorporated drug testing institutions, universities, research institutes, and TCM production/R&D enterprises |
| Submission Deadline | 8 October 2026 (based on time of receipt) |
| Funding Model | Primarily self‑funded by drafting units; special subsidies or rewards‑in‑lieu‑of‑subsidies may be sought for annual key varieties that pass review |
| Contacts | Zhao Weiquan, Sichuan MPA, +86‑28‑8678‑6031; Qing Yan, Sichuan Institute for Drug Control, +86‑28‑8175‑4502 |
Scope of Work
- Newly Added Varieties: Drafting units will conduct full quality‑standard research — literature verification, source origin, description, identification, checks, extractables, and content determination — and deliver a draft standard with drafting notes. Applications for new materials (including new botanical origins or new medicinal parts) must include origin verification, resource legality, safety, and clinical/medicinal evidence.
- Revised Varieties: Units will perform verification research targeting the specific deficiencies identified in the catalogue (e.g., missing or outdated identification methods, unreasonable ash and extractable limits, inapplicable content‑determination methods), and may propose revisions beyond the listed issues.
- Pharmacopoeia Alignment: Revisions must in principle be harmonized with the Chinese Pharmacopoeia 2025 Edition. Where Sichuan‑specific resources, clinical practice, or historical processing traditions justify divergence, applicants must submit comparative study data and rationale for expert panel adjudication.
- Decoction Pieces Gap‑Filling: For decoction pieces lacking a corresponding material standard, the notice requires either establishing the material standard first or applying through an integrated material–decoction piece package, which is explicitly encouraged.
Eligibility & Selection Process
- Qualifications: Applicants must hold independent legal‑person status with laboratory conditions, instrumentation, and technical staff adequate for TCM standards research; prior experience drafting or verifying national or provincial drug standards is a priority factor.
- Integrity Requirement: No major drug quality/safety incidents or research misconduct records in the past three years.
- Application Flexibility: One unit may apply for multiple varieties; multiple units may jointly apply for a single variety with a designated lead; applications for specific processing specifications within a multi‑specification variety are permitted.
- Review Pathway: The Sichuan Institute for Drug Control will organize formal review, expert evaluation, and on‑site defense, then recommend a candidate list for Sichuan MPA approval and public announcement.
- Submission: Two stamped paper copies to the Sichuan Institute for Drug Control (No. 8 Xinwen Road, Hi‑Tech Zone West, Pidu District, Chengdu), plus scanned and editable Word versions to zbbmsc@scidc.org.cn with the subject line “TCM Standards Drafting Unit Application + Unit Name.”
Industry Impact & Outlook
- Standards Modernization: Upgrading monographs dating to 2010 and 2015 to align with the Chinese Pharmacopoeia 2025 Edition will reset quality benchmarks for TCM materials and decoction pieces produced and circulated in Sichuan, one of China’s key TCM resource provinces.
- Strategic Opportunity: Participation gives testing institutions, academia, and TCM manufacturers direct influence over standard‑setting — positioning early entrants ahead of the compliance requirements that follow final adoption.
- Funding Watch: Research funding remains largely self‑raised; the bureau’s pledge to pursue special subsidies for prioritized varieties could tilt participation toward larger, better‑resourced institutions.
- Unclaimed Varieties: For varieties attracting no qualified applicants, the Sichuan MPA will make separate arrangements, leaving open the possibility of direct commissioning.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the selection of drafting units, the timeline for standard revision and promulgation, and potential funding support. Actual outcomes may differ due to expert review results, application volume, and final regulatory decisions by the Sichuan Provincial Drug Administration.-China Health Reform Pulse
Policy Source: http://yjj.sc.gov.cn/scyjj/gztz/2026/9/15/1d68c0260a94442cb77c1a3fdab01504.shtml