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;
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 August 2024.
1. China CDE Solicits Public Comments on the 85th RLD Lists
On August 1, China CDE consulted on the draft of the 85th lists of reference listed drugs (RLDs), encompassing 43 products. Specifically, these products include Cysteine Hydrochloride Injection, Ondansetron Hydrochloride Oral Solution, Aciclovir Oral Suspension, etc.
2. China NHSA Announces 440 Drugs Having Passed the Format Review for NRDL
On August 7, China National Healthcare Security Administration (NHSA) announced a list of 440 drugs which had passed the format review for entering the 2024 version of National Reimbursement Drug List (NRDL). These drugs will go through expert evaluation and price negotiation or bidding to finally enter the 2024 NRDL.
3. China NMPA Grants Five Rx-to-OTC Switches
In August, NMPA granted over-the-counter (OTC) status to five previous prescription drugs:
Shenqi Shiyiwei Granules
Compound Shiwuwei Chewable Tablets
Compound Taizishen Granules
Compound Chuanbei Essence Granules
Shensu Cold Tablets
For the complete OTC catalog, please refer to the BaiPharm Database.
4. China Consults on the Overarching Regulation of Medical Devices
On August 28, China's National Medical Products Administration (NMPA) released the Draft for Comments on the Medical Device Administration Law for public consultation. The deadline for submitting feedback is September 28.
The Draft covers multiple stages of medical device’s lifecycle, including research and development, manufacturing, distribution, as well as usage, along with standards, classification, safety monitoring, and recall procedures. It emphasizes the enhancement of regulatory oversight throughout the entire lifecycle of medical devices and fostering innovation.
5. China CDE Releases the 82nd RLD List
On August 30, China CDE released the 82nd list of reference listed drugs (RLDs). The list encompasses 25 products, such as Aprepitant for Oral Suspension, Methotrexate Injection, Cenobamate Tablets, Trametinib Tablets, etc.
For the complete RLD List, please refer to the BaiPharm Database.
6. China Releases Pharmaceutical Guidelines
In August 2024, China unveiled the following guidelines on chemical drugs and biological products.
7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards
In August 2024, the Chinese Pharmacopoeia Commission released 42 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods.
Excerpt of the 42 draft standards
No. | Draft standard | Type | Consultation Period (YYYY-MM-DD) |
1 | Monograph- biologics | 2024/08/06-2024/10/06 | |
2 | Monograph-chemical drug | 2024/08/12-2024/09/12 | |
3 | Monograph-chemical drug | 2024/08/12-2024/09/12 | |
4 | Monograph-excipient | 2024/08/12-2024/09/12 | |
5 | Monograph-excipient | 2024/08/12-2024/09/12 | |
6 | Monograph-excipient | 2024/08/12-2024/10/12 | |
7 | Monograph-excipient | 2024/08/12-2024/09/12 | |
8 | Monograph-excipient | 2024/08/12-2024/10/12 | |
9 | Monograph-excipient | 2024/08/12-2024/09/12 | |
10 | Monograph-excipient | 2024/08/12-2024/09/12 | |
11 | Monograph-excipient | 2024/08/12-2024/10/12 | |
12 | Lysine Hydrochloride and Calcium Hydrogen Phosphate Granules | Monograph-chemical drug | 2024/08/19-2024/09/19 |
13 | Monograph- biologics | 2024/08/19-2024/10/19 | |
14 | Monograph- biologics | 2024/08/19-2024/10/19 | |
15 | Monograph- biologics | 2024/08/22-2024/10/22 |
Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.
