Monthly Recap: China Pharmaceutical Regulatory Updates | September 2024

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 September 2024.

1. China CDE Solicits Public Comments on the 86th RLD Lists

On September 6, China CDE consulted on the draft of the 86th lists of reference listed drugs (RLDs), encompassing 35 products. Specifically, these products include Clindamycin Phosphate and Benzoyl Peroxide Gel, Compound Alverine Citrate Soft Capsules, Tegileridine Fumarate Injection, etc.

2. China Releases the Fifth List of Pediatric Drugs Encouraged for R&D

On September 9, China's National Health Commission (NHC), Ministry of Industry and Information Technology (MIIT), National Healthcare Security Administration (NHSA), and National Medical Products Administration (NMPA) jointly announced the Fifth List of Pediatric Drugs Encouraged for R&D and Marketing Authorization, containing 15 drugs. This List focuses on medications for young children, prioritizing those that address significant clinical challenges. It includes various pediatric-friendly formulations and dosages, as well as some drugs for rare diseases.

3. China CDE Completes the Consultation on Q&A on Pharmaceutical Similarity Studies of Biosimilars

From September 9 to October 9, China’s Center for Drug Evaluation (CDE) consulted a draft titled "Q&A on Pharmaceutical Similarity Studies of Biosimilars" for public comment. The draft aims to further guide and standardize pharmaceutical similarity research for biosimilars.

4. China CDE Launches Patient-Centered Action for Rare Diseases Encouragement

On September 13, China’s Center for Drug Evaluation (CDE) launched the "patient-Centered Action for Rare diseases Encouragement" (CARE Plan), effective immediately. The CARE Plan aims to integrate patient perspectives into the clinical development of rare disease drugs, especially focusing on improving the scientific, regulatory, and practical aspects of the integration. It also aims to foster collaboration and communication between regulatory bodies, drug developers, and rare disease patients, ultimately to accelerate the approval and availability of rare disease treatments.

Drug developer may submit applications to join the CARE Plan through the CDE’s communication channels. The CDE will evaluate each application based on the product’s characteristics, target indications, and submitted plans. Following evaluation, approved drugs will be made public.

5. China NHSA Releases Expert Evaluation Results for Drugs Applied for Inclusion of 2024 NRDL

On September 14, China National Healthcare Security Administration (NHSA) released the expert evaluation results of drugs that had passed the format review for entering the 2024 version of the National Reimbursement Drug List (NRDL). Companies that submitted applications can check their results by logging into the Service Platform (fuwu.nhsa.gov.cn) and then provide the required information or data based on the results.

6. China Releases Pharmaceutical Guidelines

In September 2024, China unveiled the following guidelines on chemical drugs and biological products.

7. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In September 2024, the Chinese Pharmacopoeia Commission released 86 draft standards on chemical drugs, biological products, active pharmaceutical ingredients (APIs), excipients, packaging materials, and determination methods. Details are as below.

Excerpt of the 86 draft standards

Contact BaiPharm if you are interested in learning more about the draft standards or other drug registration regulations in China.

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | August 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | July 2024

• Monthly Recap: China Pharmaceutical Regulatory Updates | June 2024