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 December 2024.
1. China Releases Several Lists of Reference Listed Drugs (RLDs)
In December, China published the following updates to the Reference Listed Drugs (RLDs) lists:
For the complete RLDs List, please refer to the BaiPharm Database.
2. China NMPA Grants One Rx-to-OTC Switch
In December, NMPA granted over-the-counter (OTC) status to one previous prescription drugs: Ketoprofen Patch.
For the complete OTC catalog, please refer to the BaiPharm Database.
3. China Simplifies Registration for Hong Kong and Macao Traditional Chinese Medicines in Mainland
To promote the development of traditional Chinese medicine (TCM) in the Hong Kong and Macao Special Administrative Regions, in December China’s NMPA and CDE introduced new policies to streamline the registration process for traditional oral Chinese patent medicines already marketed in these regions.
The initiatives, outlined in two draft documents for public consultation, aim to simplify submission requirements and approval procedures. The drafts are titled Announcement on Simplifying Mainland Registration and Approval Procedures for Traditional Oral Chinese Patent Medicines Already Listed in Hong Kong and Macao and Simplified Submission Requirements and Technical Standards for Mainland Registration of Traditional Oral Chinese Patent Medicines Already Listed in Hong Kong and Macao.
The streamlined process applies to products meeting three conditions: they must be held by manufacturers registered in Hong Kong or Macao, have been approved and used locally for over 15 years, and comply with Good Manufacturing Practice (GMP) standards.
4. China Announces Results of the 10th Round of Volume-Based Drug Procurement (VBP)
On December 30, China's National Joint Drug Procurement Office officially released the results of the 10th round of the VBP. The implementation of the selected drugs will commence in April 2025, with the specific start dates depending on provincial notifications.
This round of VBP successfully covered 62 drugs, all of which are off-patent, widely produced, and highly competitive. The selected drugs cover a wide range of therapeutic areas, including hypertension, diabetes, oncology, cardiovascular and cerebrovascular diseases, infections, and mental health conditions.
5. China Authorizes 5 Drugs for Inclusion in the CARE Plan
China CDE launched the "patient-Centered Action for Rare diseases Encouragement" (CARE Plan) in September. Drug developer can submit applications to join the CARE Plan through the CDE's communication channels. In December, the following five drugs received approval to be included in the CARE Plan:
RAG-17 Injection from Ractigen Therapeutics
VGR-R01 from Shanghai Vitalgen BioPharma Co., Ltd.
ALXN2350 Injection from AstraZeneca Global R&D (China) Co., Ltd.
FHND1002 Granules from Jiangsu CTFH Pharmaceutical Co., Ltd.
ALXN1850 Injection from AstraZeneca Global R&D (China) Co., Ltd.
6. China Releases Pharmaceutical Guidelines
In December 2024, China unveiled the following guidelines on chemical drugs and biological products.
7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In December 2024, the Chinese Pharmacopoeia Commission released 25 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods. Details are as below:
Excerpt of the 25 draft standards
No. | Draft standard | Type | Consultation Period (YYYY-MM-DD) |
1 | Troxerutin Injection | Monograph- chemical drug | 2024-12-06 ~ 2025-01-06 |
2 | Human Growth Hormone Injection | Monograph- biologics | 2024-12-23 ~ 2025-01-06 |
3 | Yellow Fever Vaccine, Live | Monograph- biologics | 2024-12-26 ~ 2025-02-24 |
4 | Heparin Calcium Injection | Monograph- chemical drug | 2024-12-26 ~ 2025-01-25 |
5 | Heparin Sodium Injection | Monograph- chemical drug | 2024-12-26 ~ 2025-01-25 |
6 | Methylenediphosphonate and Stannous Chloride for Injection | Monograph- chemical drug | 2024-12-26 ~ 2025-01-25 |
7 | Polyacrylic Acid Solution 30000 | Monograph-excipient | 2024-12-30 ~ 2025-03-30 |
8 | Polyacrylic Acid Solution 1500 | Monograph-excipient | 2024-12-31 ~ 2025-03-31 |
Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.
