Editor's Notes: Monthly recap is a collection of China's laws, regulations, standards, and policies on chemical drugs and biological products. Generally, the regulatory updates are from these authorities:
National Medical Products Administration (NMPA);
Center for Drug Evaluation (CDE), NMPA;
Center for Food and Drug Inspection (CFDI), NMPA
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 November 2024.
1. China CDE Solicits Public Comments on the 88th RLD Lists
On November 1, China CDE consulted on the draft of the 88th lists of reference listed drugs (RLDs), encompassing 48 products. Specifically, these products include Hybutimibe Tablets, Dolutegravir Sodium Dispersible Tablets, Lemborexant Tablets, etc.
For the complete RLD List, please refer to the BaiPharm Database.
2. China Strengthens Oversight of Contract Drug Manufacturing
On November 5, China NMPA released a Notice on Strengthening the Supervision and Management of Contract Drug Manufacturing for public consultation. The Notice focuses on reinforcing the quality accountability of consigner enterprises as well as intensifying on-site inspections and GMP compliance assessments for manufacturers.
3. China Standardizes Qualifications of and Requirements for Domestic Responsible Persons Designated by Overseas MAHs
On November 14, China NMPA issued the Interim Provisions on the Management of Designated Domestic Responsible Persons by Overseas Marketing Authorization Holders (MAH) of Drugs. The Provisions establishes a comprehensive framework for the qualifications of and requirements for domestic responsible persons designated by overseas drug MAHs, and provides clear guidelines for reporting information about domestic responsible persons.
4. China Launches the 10th Round of Volume-Based Drug Procurement (VBP)
On November 22, the China National Joint Drug Procurement Office launched the 10th round of volume-based procurement (VBP), involving 62 drugs, such as Apremilast Tablets, Esmolol Hydrochloride and Sodium Chloride Injection, Macitentan Tablets, and Pregabalin Oral Solution. Their therapeutic areas include eight key categories: cardiovascular therapeutics, gastrointestinal and metabolic therapeutics, hematologic and hematopoietic agents, neurologic therapeutics, oncologic and immunomodulatory therapies, respiratory therapies, genitourinary and gynecological treatments, as well as musculoskeletal system therapies. Cardiovascular therapeutics as well as gastrointestinal and metabolic therapeutics account for the largest portions, comprising 12 and 10 products, respectively.
5. China Adds 91 Drugs to 2024 National Reimbursement Drug List (NRDL)
On November 28, China NHSA unveiled the 2024 National Reimbursement Drug List (NRDL), scheduled to be implemented on January 1, 2025.
A total of 91 new drugs have been added to the 2024 NRDL, while 43 drugs that are clinically replaced, no longer produced or no longer supplied have been removed. Following this adjustment, the total number of drugs listed in the NRDL stands at 3,159, including 1,765 chemical drugs and biological products, 1,394 Chinese patent medicines, and 892 types of traditional Chinese medicine pieces for decoction.
According to NHSA, 117 off-list drugs took part in the negotiation and bidding process this year, among which 89 successfully negotiated, achieving a success rate of 76% and an average price reduction of 63%.
6. China NMPA Grants Five Rx-to-OTC Switches
In November, NMPA granted over-the-counter (OTC) status to five previous prescription drugs:
Shanheye Mixture
Bailing Granules
Lianqian Pearl Dropping Pills
Qinbaohong Cough Relief Mixture
Pudilan Anti-inflammatory Oral Liquid
For the complete OTC catalog, please refer to the BaiPharm Database.
7. China Authorizes Six Drugs for Inclusion in the CARE Plan
China CDE launched the Patient-Centered Action for Rare Diseases Encouragement" (CARE Plan) in September 2024. Drug developer can submit applications to join the CARE Plan through the CDE’s communication channels. In November, the following six drugs received approval:
Fitusiran Injection
Hydroxocobalamine Hydrochloride Injection
FHND1002 Granules
ALXN1850 Injection
RAG-17 Injection
VGR-R01
8. China Consults on Administrative Measures on National Essential Medicine List
On November 15, China NHC issued a draft revision of the Administrative Measures on National Essential Medicine List for public feedback. According to the draft, essential medicines should meet the below conditions:
The drug addresses fundamental needs for disease prevention and treatment
The drug aligns with China’s current conditions and healthcare capacity
The drug has appropriate formulations
The drug is affordably priced, reliably supplied, and accessible to all
The National Essential Medicine List will be periodically updated based on the clinical use, changes in drug standards, and the availability of newly approved medicines.
9. China Authorizes Ten Provinces/Cities to Launch Pilot Program for Drug Supplemental Application Reviews
In November 2024, China’s NMPA authorized Beijing, Tianjin, Hebei, Shanghai, Jiangsu, Zhejiang, Shandong, Guangdong, Chongqing, and Sichuan to launch a pilot reform program aimed at optimizing the review and approval process for drug supplemental applications. Concurrently, the CDE introduced a related application module on its "Applicant's Window" platform. Marketing authorization holders (MAHs) in the ten pilot regions can submit the applications to their respective provincial authorities through the module as per the program’s requirements.
10. China Releases Pharmaceutical Guidelines
In November 2024, China unveiled the following guidelines on chemical drugs and biological products.
No | Guidelines | Authority | Status | Issued (YYYY-MM-DD) | Enforced Date (YYYY-MM-DD) |
1 | CDE | In force | 2024/11/01 | 2024/11/01 | |
2 | Technical Guidelines on the Application of Disease Registry-Based Real-World Data (Trial) | CDE | In force | 2024/11/15 | 2024/11/15 |
3 | CFDI | Draft | 2024/11/15 | / | |
4 | Technical Guidelines on Electronic Records in Bioequivalence Testing | CFDI | Draft | 2024/11/18 | / |
5 | Technical Guidelines on the Management of Phase I Clinical Trials of Drugs | CFDI | Draft | 2024/11/18 | / |
CFDI | Draft | 2024/11/18 | / | ||
7 | NMPA | In force | 2024/11/19 | 2024/11/19 | |
8 | Technical Guidelines on Clinical Pharmacology Studies on Cell Therapy Products (Trial) | NMPA | In force | 2024/11/19 | 2024/11/19 |
9 | Adoption of ICH E6 (R3) Guideline on Good Clinical Practice (GCP) | CFDI | Draft | 2024/11/29 | / |
11. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In November 2024, the Chinese Pharmacopoeia Commission released 17 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.
Excerpt of the 17 draft standards
No. | Draft standard | Type | Consultation Period (YYYY-MM-DD) |
1 | Monograph-excipient | 2024/11/26-2024/12/27 | |
2 | Monograph-excipient | 2024/11/26-2024/12/27 | |
3 | Monograph- chemical drug | 2024/11/15-2024/12/16 |
Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.
