Editor's Notes: Monthly recap is a collection of China's laws, regulations, policies, and standards on medicines, including chemicals and biologics. Generally, they are issued by these 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 August 2023.
China Consults on Conditional Approval Process
China Rolls out 71st and 72nd Lists of RLDs
China Grants Two Rx-to-OTC Switches
China Releases Pharmaceutical Guidelines
China Consults on Drafts of Drug Standards
1. China Consults on Conditional Approval Process
On Aug. 25, 2023, China NMPA released the revised draft of Work Process for Conditional Approval of Drug Marketing Authorization Applications (Trial).
As one of the four expedited programs for drug registration in China, conditional approval’s general requirements are briefly stated in the Provisions of Drug Registration along with other three expedited programs—breakthrough therapy, priority review, and special approval.
Now the newly revised draft focuses on the procedures of submission, review, and approval. The draft’s previous version, also the currently effective version, was issued in 2020.
Compared to the previous version, the new draft solves more problems that may have appeared in the practice, e.g., request for changing the marketing authorization holder (MAH) after the drug has been conditionally approved but not fully approved. Such a request will be dismissed according to the draft. Get more details at BaiPharm News.
2. China Rolls out 71st and 72nd Lists of RLDs
On Aug. 17 and 23, China NMPA published the 71st and 72nd lists of reference listed drugs (RLDs) respectively. The two lists cover 58 reference drugs, including Toray Industries’ Beraprost Sodium Sustained-release Tablets and GSK’s Terbinafine Hydrochloride Pigment. View the full RLD catalog at BaiPharm Database.
3. China Grants Two Rx-to-OTC Switches
In August 2023, China NMPA announced Rx-to-OTC switches of two drugs:
Paracetamol Orally Disintegrating Tablets;
Antiviral Dripping Pill (Kangbingdu Di Wan).
View the full OTC drug catalog at BaiPharm Database.
4. China Releases Pharmaceutical Guidelines
In August 2023, Chinese drug regulators issued the following guidelines:
No. | Draft guidelines | Authority | Status | Issued | Enforced |
1 | ICH & NMPA | In force | 25/08/2023 | 25/08/2023 | |
2 | CDE | Draft | 01/08/2023 | / | |
3 | Guidelines on the R&D of Oral Combination Drugs for Type-2 Diabetes Mellitus | CDE | In force | 02/08/2023 | 02/08/2023 |
4 | 1) Technical Guidelines for Bioequivalence Studies on Azathioprine Tablets 2) Technical Guidelines for Bioequivalence Studies on Mercaptopurine Tablets 3) Technical Guidelines for Bioequivalence Studies on Regorafenib Tablets 4) Technical Guidelines for Bioequivalence Studies on Octreotide Acetate Microspheres for Injection 5) Technical Guidelines for Bioequivalence Studies on Omeprazole and Sodium Bicarbonate Capsules | CDE | Draft | 22/08/2023 | / |
5 | ICH & CDE | Draft | 25/08/2023 | / | |
6 | 2) Technical Guidelines on CMC Post-approval Changes of Vaccines | CDE | Draft | 28/08/2023 | / |
5. China Consults on Drafts of Drug Standards
In August 2023, the Chinese Pharmacopoeia Commission released the following draft standards.
No. | Draft standard | Type | Consultation period |
1 | 5400 Metal Components and Containers for Pharmaceutical Packaging 5401 Metal Tubes for Pharmaceutical Packaging for Ointment 5402 Metal Cans for Aerosol for Inhalation 5403 Metal Boxes for Preparations for External Use 5404 Metal Cans for Aerosol for External Use | General chapter on pharmaceutical packaging | 15/08/2023-14/09/2023 |
2 | General chapter on pharmaceutical packaging | 23/08/2023-23/09/2023 | |
3 | Guideline | 03/08/2023-02/11/2023 | |
4 | Monograph on active pharmaceutical ingredient (API) | 03/08/2023-02/11/2023 | |
5 | Monograph on chemical drug | 03/08/2023-02/11/2023 | |
6 | Monograph on excipient | 03/08/2023-02/11/2023 | |
7 | Monograph on excipient | 03/08/2023-02/11/2023 | |
8 | Guiqi Yangxue Yiqi Oral Solution (Guiqi Yangxue Yiqi Koufuye) | Monograph on traditional Chinese medicine (TCM) | 03/08/2023-02/11/2023 |
9 | Monograph on TCM | 03/08/2023-02/11/2023 | |
10 | Monograph on TCM | 15/08/2023-14/11/2023 | |
11 | Shenrong Spleen-strengthening Tablets (Shenrong Qiangshen Pian) | Monograph on TCM | 15/08/2023-14/11/2023 |
12 | Metronidazole, Clotrimazole and Chlorhexidine Acetate Suppositories | Monograph on chemical drug | 15/08/2023-14/11/2023 |
13 | Monograph on TCM | 15/08/2023-14/11/2023 | |
14 | Monograph on TCM | 15/08/2023-14/11/2023 | |
15 | Monograph on TCM | 15/08/2023-14/11/2023 | |
16 | Monograph on TCM | 15/08/2023-14/11/2023 | |
17 | Monograph on TCM | 15/08/2023-14/11/2023 | |
18 | Monograph on TCM | 15/08/2023-14/11/2023 | |
19 | Monograph on TCM | 22/08/2023-21/11/2023 | |
20 | Monograph on excipient | 22/08/2023-21/11/2023 | |
21 | Monograph on chemical drug | 22/08/2023-22/09/2023 | |
22 | Determination method | 23/08/2023-22/11/2023 | |
23 | Monograph on TCM | 23/08/2023-22/11/2023 | |
24 | Pumpkin Yangyin Combination Granules (Fufang Nangua Yangyin San) | Monograph on TCM | 23/08/2023-22/11/2023D |
25 | Di’ao Cardiovascular Health Capsules (Di’ao Xinxuekang Capsules) | Monograph on TCM | 23/08/2023-23/09/2023 |
26 | Spleen-strengthening Digestion-promoting Oral Solution (Bupi Xiaoji Koufuye) | Monograph on TCM | 24/08/2023-23/11/2023 |
27 | Monograph on TCM | 29/08/2023-28/11/2023 | |
28 | Monograph on API | 31/08/2023-30/11/2023 | |
29 | Monograph on chemical drug | 31/08/2023-30/11/2023 |
Contact BaiPharm if you’d like to know more about drug regulations in China.
