Editor's Notes: Monthly recap is a collection of China's pharmaceutical laws, regulations, policies, and standards recently issued by the following authorities:
National Medical Products Administration (NMPA);
NMPA's Center for Drug Evaluation (CDE);
National Health Commission (NHC);
National Healthcare Security Administration (NHSA);
National Joint Drug Procurement Office;
Chinese Pharmacopoeia (ChP) Commission.
The following are the regulatory updates in Apr. 2023.
1. China Grants Four Rx-to-OTC Switches
On Apr. 28, China NMPA announced Rx-to-OTC of four chemical drugs—Desloratadine Dispersible Tablets, Loratadine Granules, Ambroxol Hydrochloride Orally Disintegrating Tablets, and Naproxen Sodium Tablets. View the full OTC catalog at BaiPharm Database.
2. China Adjusts Catalogs of Anesthetics and Psychoactive Drugs
On Apr. 18, NMPA, the Ministry of Public Security, and NHC made four adjustments to the Catalogs of Anesthetics and Psychotropic Drugs. The adjustments will take effect on July 1, 2023.
1) Oliceridine is included in the Catalog of Anesthetics.
2) The compound preparations of suvorexant, perampanel, eptazocine, and tramadol are included in the Catalog of Psychotropic Drugs (Category II).
3) Compound oral solid preparations, which contain more than 5 mg hydrocodone base per dosage unit and do not contain other anesthetics, psychotropic drugs, or pharmaceutical precursor chemicals, are included in the Catalog of Psychotropic Drugs (Category I).
4) Compound oral solid preparations, which contain no more than 5 mg hydrocodone base per dosage unit and do not contain other anesthetics, psychotropic drugs, or pharmaceutical precursor chemicals, are included in the Catalog of Psychotropic Drugs (Category II).
3. China Reveals the 8th Medical VBP’s Bidding Result
On Apr. 11, 2023, China National Joint Drug Procurement Office announced the bidding result of the 8th national volume-based procurement (VBP), a bulk-purchase program launched in 2018 intended for cutting the costs of medicines prescribed in public hospitals.
The 8th VBP covers 39 drugs (number based on generic name) with an average price cut of 56%, estimated to save 16.7 billion yuan (circa 2.41 billion USD) each year until the end of 2025 based on the planned procurement volumes.
Among 366 specific products (number based on generic name, specification, and manufacturer) from 251 companies that participated in the bidding, 252 products from 174 bidders won their places in the VBP program. Five bid-winning products are foreign while the other 247 products are domestic. Read more at BaiPharm’s article.
China’s 8th Medical VBP: Five Bid-winning Products Owned by Foreign Companies
Oseltamivir Phosphate for Suspension
Hetero Labs Limited
Aurobindo Pharma Limited
N.V. Organon (Organon Pharma (UK) Limited) (re-packaged by MSD Hangzhou)
Cefodizime Sodium for Injection
DAEWOONG BIO INC.
Source: Sunshine Medical Procurement All-In-One
4. China Issues 13 Guidelines and Adopts One ICH Guideline
In Apr. 2023, China NMPA adopted ICH E19 guideline; CDE issued 11 guidelines with immediate effect and 2 drafts for public comments.
5. China Consults on Draft Standards
In Apr. 2023, Chinese Pharmacopoeia Commission released the following draft standards for consultation.
5304 Plastic Composited Tubes and Components for Ointment for External Use
5307 Plastic Composite Film and Bag for Oral Solid Preparation
4027 Determination of Plastic Sheet’s Dimensional Change on Heating
4207 Determination of Solvent Residues in Pharmaceutical Packaging
4210 Determination of Vinyl Chloride Monomer and Vinylidene Chloride Monomer in Rigid Sheet
Contact BaiPharm if you’d like to consult about drug regulatory affairs in China.
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2023
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023