Effective 1 July 2025, a package of new pharmaceutical policies and regulations officially takes effect:

1. Drug trace-code scanning required for medical-insurance reimbursement

A joint notice issued by the National Healthcare Security Administration, the Ministry of Human Resources and Social Security, the National Health Commission and the National Medical Products Administration (NMPA) stipulates that, as a rule, starting 1 July 2025, settlement by medical-insurance funds is allowed only after the trace-code on each unit has been scanned at the point of sale. Drugs that were procured before the deadline and lack trace-codes will be managed via a “no-code database” and may still be reimbursed on a transitional basis. From 1 January 2026, all medical institutions must upload the full set of drug trace-codes.

2. Rules on domestic agents for overseas MAHs now in force

The NMPA’s Interim Provisions on the Designation of Domestic Responsible Persons by Overseas Marketing Authorisation Holders come into effect on 1 July 2025; the relevant NMPA IT system modules were already activated on 14 November 2024.

3. Drug-manufacturing licences to carry QR-code electronic certificates

NMPA Announcement No. 35 of 2025 requires that all Drug Manufacturing Licences (including those for radiopharmaceuticals) issued after 1 July 2025 must display a QR-code electronic certificate. Both paper originals and duplicates, as well as the e-certificate, must bear the QR code. From 1 January 2026, scanning the code must instantly display identical information for both original and duplicate, with data refreshed dynamically.

4. Two precursors added to the Regulations on Precursor Chemicals on 20 July

Approved by the State Council, the Ministry of Public Security, the Ministry of Commerce, the National Health Commission, the Ministry of Emergency Management, the General Administration of Customs and the NMPA have placed 4-piperidone and 1-Boc-4-piperidone in Schedule II of the Regulations on Precursor Chemicals. Their production, distribution, purchase, transport and import/export will be governed by the rules for non-drug precursor chemicals.

5. Jiangxi Processing Specifications for Traditional Chinese Medicine Decoction Pieces (2023 edition) now in force

The bound volume of the 2023 edition becomes mandatory on 1 July 2025. From that date, all decoction pieces listed in the volume must meet its requirements. A total of 397 varieties and 546 specifications are covered, including newly added, revised and region-specific methods.

l 53 new specifications such as Wen Yuzhu have been added.

l Four modern-processing standards are introduced, e.g., freeze-dried Dendrobium officinale slices.

l Safety limits for toxic components, heavy metals, sulfur dioxide, pesticides and aflatoxins have been tightened and scientifically justified.

6. Anhui publishes specifications for 16 fresh-cut TCM herbs—effective immediately

On 24 June 2025, the Anhui Medical Products Administration released processing specifications and quality standards for 16 fresh-cut traditional Chinese medicinal materials, effective from the date of issuance.

The 16 varieties: Gastrodiae Rhizoma (Tianma), Isatidis Radix (Banlangen), Eucommiae Cortex (Duzhong), Salviae Miltiorrhizae Radix et Rhizoma (Danshen), Ganoderma (Lingzhi), Anemarrhenae Rhizoma (Zhimu), Polygoni Multiflori Radix (Heshouwu), Platycodonis Radix (Jiegeng), Paeoniae Radix Alba (Baishao), Mori Ramulus (Sangzhi), Mori Cortex (Sangbaipi), Asteris Radix (Ziwan), Belamcandae Rhizoma (Shegan), Atractylodis Macrocephalae Rhizoma (Baizhu), Cirisii Herba (Daji), Agastaches Herba (Huoxiang).