Monthly Recap: China Pharmaceutical Regulatory Updates | April 2023

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
Generic Name	Dosage Form	Specification	Price	Company
Oseltamivir Phosphate for Suspension	Oral suspension	0.36g*1 bottle/box	35.11 yuan/box	Hetero Labs Limited
Mirtazapine Tablets	Tablet	15mg*2×14 tablets/box	34.46 yuan/box	Aurobindo Pharma Limited
Mirtazapine Tablets	Tablet	30mg*10 tablets/box	24.20 yuan/box	N.V. Organon (Organon Pharma (UK) Limited) (re-packaged by MSD Hangzhou)
Levocarnitine Injection	Injection	5ml:1g*5 injections/box	45.00 yuan/box	ALFASIGMA S.p.A.
Cefodizime Sodium for Injection	Injection	0.5g*10 bottles/box	41.20 yuan/box	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.

No.	Guidelines	Authority	Status	Issued	Enforced/ Adopted
1	Technical Guidelines on Clinical R&D of Antibody-Drug Conjugates (ADCs)	CDE	In force	07/04/2023	07/04/2023
2	Technical Guidelines for Drug Research Based on Animal Rule (Trial)	CDE	In force	07/04/2023	07/04/2023
3	Guidelines on Qualitative Methodology for Extrapolation of Medicine Use Data from Adults to Pediatric Patients (Trial)	CDE	In force	12/04/2023	12/04/2023
4	Technical Guidelines on Clinical Trial for Drugs for Respiratory Syncytial Virus (RSV) Infection	CDE	In force	12/04/2023	12/04/2023
5	Technical Guidelines on Clinical Trial Design for Gene Therapy for Hemophilia	CDE	In force	14/04/2023	14/04/2023
6	Technical Guidelines on Clinical R&D of New Combination TCMs for Treating Malignant Tumors (Trial)	CDE	In force	14/04/2023	14/04/2023
7	Detailed Rules on the Administrative Work and Application of Type I Meetings for Communication on Pediatric Drugs (Trial)	CDE	In force	18/04/2023	18/04/2023
8	Advice on Adopting “ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management”	CDE	Draft	26/04/2023	/
9	Technical Guidelines on Clinical Trials for Active Immunotherapy Products for Tumor (Trial)	CDE	In force	26/04/2023	26/04/2023
10	Technical Guidelines on Clinical Trial for Therapeutic Drugs for Chronic Hepatitis B Virus (HBV) Infection	CDE	In force	27/04/2023	27/04/2023
11	Technical Guidelines on CMC Study and Evaluation of Human Stem Cell Products (Trial)	CDE	In force	27/04/2023	27/04/2023
12	Advice on Adopting “ICH S12: Nonclinical Biodistribution Considerations for Gene Therapy Products”, its original text in English, and Chinese translation	CDE	Draft	28/04/2023	/
13	Technical Guidelines on Clinical R&D on the Antineoplastic Photodynamic Therapeutic Drugs (Trial)	CDE	In force	28/04/2023	28/04/2023
14	ICH E19: Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials	ICH	In force	24/04/2023	21/10/2023

5. China Consults on Draft Standards

In Apr. 2023, Chinese Pharmacopoeia Commission released the following draft standards for consultation.

No.	Draft Standard	Type	Issued
1	5301 Plastic Containers and Components for Injection	General chapter	03/04/2023
2	5304 Plastic Composited Tubes and Components for Ointment for External Use	General chapter	03/04/2023
3	5307 Plastic Composite Film and Bag for Oral Solid Preparation	General chapter	03/04/2023
4	5308 Rigid Plastic Sheet for Oral Solid Preparation	General chapter	03/04/2023
5	4026 Test for Pressure Resistance of Plastics	Test method	03/04/2023
6	4027 Determination of Plastic Sheet’s Dimensional Change on Heating	Determination method	03/04/2023
7	4207 Determination of Solvent Residues in Pharmaceutical Packaging	Determination method	03/04/2023
8	4210 Determination of Vinyl Chloride Monomer and Vinylidene Chloride Monomer in Rigid Sheet	Determination method	03/04/2023
9	Test for Nuclease Residue	Test method	23/04/2023

Contact BaiPharm if you’d like to consult about drug regulatory affairs in China.

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