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 June 2023.
1. China NMPA Announces Three Rx-to-OTC Switches
2. China NMPA Releases the 69th RLD List
3. China NMPA Specifies GLP Certification Requirements
4. China NMPA to Make Medication Package Inserts Friendlier to Senior Patients
5. China NMPA Revises Administrative Measures for Drug Inspection
6. China CDE Releases Nine (Three in Effect and Six in Consultation) Pharmaceutical Guidelines
7. Chinese Pharmacopoeia Commission Consults on One Standard on the Generic Names of Pharmaceutical Packaging Materials
1. China Announces Three Rx-to-OTC Switches
In June, three drugs—Zhongsheng Capsules, Reyanning Combination Preparation, and Yinhuang Hanhua Dripping Pills—were announced by NMPA to be granted with OTC status. The first two now are both prescription (Rx) and OTC drugs, while the third is OTC alone. View the full OTC drug catalog at BaiPharm Database.
RELATED: China Updates Documentation Requirements for Rx-to-OTC Switch Applications
2. China Releases the 69th RLD List
On June 26, NMPA released the 69th list of reference listed drugs, which includes Genentech, Inc.’s Pralsetinib Capsules and Bridging Pharma GmbH’s Oryz-Aspergillus Enzyme and Pancreatin Tablet. View the full RLD Catalog at BaiPharm Database.
3. China Specifies GLP Certification Requirements
On June 21, NMPA announced the detailed requirements supplementing the Administrative Measures for Drug Good Laboratory Practice (GLP) Certification (hereafter referred to as GLP Certification Measures), which took effect on July 1, 2023.
NMPA says the new GLP certificate, issued on or after July 1, 2023, will be effective for 5 years.
Institutions that have obtained GLP certificates before July 1, 2023, are required to obey the rules indicated in the table below; otherwise their certificates will expire.
GLP Certificate Issued | The Last Periodic Inspection / the First Certification Took Place | Time for Submitting Certificate Renewal Application |
Before 01/07/2023 | On or between 30/06/2020 and 30/06/2023 | At least 3 years after but before 3 years and 6 months after the date of the last periodic inspection / the first certification |
Before 01/07/2023 | Before 30/06/2020 | Before 31/12/2023 |
With the GLP Certification Measures in effect, NMPA now accepts, reviews, and approves GLP certification applications via its online administrative platform (https://zwfw.nmpa.gov.cn/).
4. China to Make Medication Package Inserts Friendlier to Senior Patients
On June 29, NMPA issued a draft on a pilot program for adjusting medication package inserts to the convenience of senior patients, as the font size of the instructions on the current inserts is too small for some of them. The program is only targeted at drug preparations indicated for elderly patients for oral or external use.
Shanghai, Jiangsu, Zhejiang, Shandong, Hunan, and Guangdong are the six regions that must organize 5-10 local marketing authorization holders (MAHs) to attend the pilot program.
If domestic MAHs in other regions and foreign MAHs want to join in the plan, the domestic ones should submit applications to the local provincial medical products administration and foreign ones to CDE.
Each MAH is supposed to simplify the format and typeface of 5-10 products’ medication package inserts without changing the original content.
NMPA also released the drafts of 1) writing guidance for the simplified version of medication package inserts and 2) the format requirements for the electronic complete version, for MAHs’ reference.
5. China Revises Administrative Measures for Drug Inspection
On June 30, NMPA rolled out the draft of Revised Articles of the Administrative Measures for Drug Inspection (Trial). The revised version was released with immediate effect on July 21, 2023. Subscribe to BaiPharm Newsletter and we’ll send the report on the revised version to you soon.
6. China Releases Pharmaceutical Guidelines
No. | Draft Guidelines | Authority | Status | Issued | Enforced |
1 | CDE | In force | 09/06/2023 | 09/06/2023 | |
2 | CDE | In force | 21/06/2023 | 21/06/2023 | |
3 | Technical Guidelines on Benefit-risk Assessment for New Drugs | CDE | In force | 25/06/2023 | 25/06/2023 |
4 | CDE | Draft | 20/06/2023 | / | |
5 | CDE | Draft | 21/06/2023 | / | |
6 | Technical Guidelines on Non-clinical Study on Therapeutic Radiopharmaceuticals | CDE | Draft | 26/06/2023 | / |
7 | CDE | Draft | 26/06/2023 | / | |
8 | CDE | Draft | 27/06/2023 | / | |
9 | CDE | Draft | 30/06/2023 | / |
7. China Consults on Drug Standard
In June 2023, the Chinese Pharmacopoeia Commission issued one drug standard draft for public comments.
No. | Draft Standard | Type | Issued |
1 | Nomenclative Guidelines on the Generic Names of Pharmaceutical Packaging Materials | Guideline | 29/06/2023 |
Contact BaiPharm if you’d like to know more about drug regulatory affairs in China.
