Monthly Recap: China Pharmaceutical Regulatory Updates | October 2023

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);

• 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 October 2023.

1. NMPA Enforces Regulation on API Registration Renewal

2. NMPA Tightens Regulation on Outsourced Manufacturing for MAHs

3. NMPA and NHC Announce Chinese Pharmacopoeia 2020 Edition’s 1st Addendum

4. NMPA Requires ANDAs Without RLDs to Demonstrate Clinical Value

5. NMPA Releases the 73rd List of RLDs

6. SAMR Details Drug Suppliers’ Qualifications and Obligations

7. NMPA Announced the Customs Codes of Specific Anesthetics and Psychotropics

8. NMPA and NHC Enhance Supervision on Etomidate and Modafinil

9. NMPA Pilots Reform of Medication Package Inserts for Elderly Patients and Patients with Disabilities

10. NMPA Consults on Rules for Discretion of Administrative Penalties Involving Drugs

11. NMPA and CDE Release Pharmaceutical Guidelines

12. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

1. NMPA Enforces Regulation on API Registration Renewal

On October 13, 2023, China NMPA implemented the Notice on the Administration of Chemical API Registration Renewal. Registration renewal applies to APIs that have obtained approval number or approval notification. Learn about the detailed requirements at BaiPharm News.

2. NMPA Tightens Regulation on Outsourced Manufacturing for MAHs

On October 23, 2023, China NMPA issued the Notice on Enhancing the Supervision and Management of Outsourced Manufacturing for Drug Marketing Authorization Holders (MAHs) (referred to as the Notice), which took immediate effect. 

The Notice came out in response to the growing trend R&D institutions and contract sales organizations (CSOs) utilize the MAH system to obtain drug marketing authorizations and subsequently outsource manufacturing activities to contract manufacturing organizations (CMOs). However, some of these MAHs lack qualified personnel for quality assurance, raising doubts about their ability to effectively oversee the manufacturing activities of CMOs. 

To address the potential compliance issues associated with outsourced manufacturing, the NMPA enforces the Notice to strengthen the authorization process for outsourcing manufacturing and outline MAH’s quality management obligations in relation to outsourced manufacturing activities. Get more details at BaiPharm News.

3. NMPA and NHC Announce Chinese Pharmacopoeia 2020 Edition’s 1st Addendum

On October 12, 2023, China NMPA and NHC jointly announced the release of the first Addendum to the Chinese Pharmacopoeia 2020 Edition. The authorities disclosed the contents of the Addendum, but did not provide the main texts. It was stated that the Addendum has been compiled and is planned to be implemented on March 12, 2024. Learn more about the Addendum at BaiPharm News.

4. NMPA Requires ANDAs Without RLDs to Demonstrate Clinical Value

On October 13, 2023, China NMPA announced regulations on generic drug registration / abbreviated new drug application (ANDA) have no reference listed drugs (RLDs).

As per the announcement, ANDA without RLD means that the applicant plans to copy a drug that is not in the RLD Catalog. For such a generic candidate, NMPA requires the applicant to fulfil the following requirements:

• Conducting chemistry, manufacturing, and controls (CMC) studies to prove the proposed generic drug’s equivalence to the marketed drugs with the same active pharmaceutical ingredient (API);

• Assessing and demonstrating the proposed drug’s clinical value;

• Submitting a communication application for having a type-III meeting with CDE.

Learn about specific requirements at BaiPharm News.

5. NMPA Releases the 73rd List of RLDs

On October 26, 2023, China NMPA released the 73rd list of RLDs, including 103 products such as Procarbazine hydrochloride Capsules held by Leadiant Biosciences, Inc. View the whole list at BaiPharm Database.

6. SAMR Details Drug Suppliers’ Qualifications and Obligations

On October 13, 2023, China’s State Administration for Market Regulation (SAMR) published the Administrative Measures for Supervising the Quality of Drug Supply and Use (referred to as the Administrative Measures), which is scheduled to take effect on Jan. 1, 2024.

The Administrative Measures comprises 7 chapters, encompassing a total of 79 articles. It mainly addresses the obligations of businesses that supply drugs and medical institutions that use drugs. Learn more at BaiPharm News. 

7. NMPA Announced the Customs Codes of Specific Anesthetics and Psychotropics

On October 13, 2023, China NMPA and the General Administration of Customs announced the customs codes of tegileridine, an anesthetic, and dimdazenil and etomidate, two Category II psychotropics.

Table 1: Customs codes of tegileridine, dimdazenil, and etomidate

8. NMPA and NHC Enhance Supervision on Etomidate and Modafinil

On October 7, 2023, China NMPA and NHC jointly announced that as of October 1, 2023, etomidate, as an API, and modafinil (including its salts, isomers, and single-agent preparations), have been categorized as Category II psychotropic drugs. 

Both of these drugs are now subject to stringent regulations. For instance, manufacturers are required to obtain specific designated manufacturing licenses in order to produce etomidate API. Additionally, they must be listed in the etomidate manufacturing plan, which is notified to the local provincial-level administration. As for modafinil, it is subject to intensive monitoring to prevent its abuse. 

9. NMPA Pilots Reform of Medication Package Inserts for Elderly Patients and Patients with Disabilities

On October 31, 2023, China NMPA implemented the Work Plan for Pilot Reforms of Medication Package Inserts to be Age-friendly and Barrier-free. The reform is targeted at commonly used oral dosage forms and externally applied medications.

Marketing authorization holders (MAHs) participating in the pilot program are allowed to adjust the format and font of the medication package inserts while ensuring the content remains unchanged. Furthermore, the utilization of audio broadcast and braille is encouraged for the inserts and labels, with the aim of enhancing accessibility for the elderly and individuals with visual impairments.

10. NMPA Consults on Rules for Discretion of Administrative Penalties Involving Drugs

On October 19, 2023, China NMPA released the draft Applicable Rules on the Discretion of Administrative Penalties in Drug Supervision and Administration, inviting public feedback. The draft outlines the criteria and procedures for imposing administrative penalties on violations related to medicines.

For example, the draft recommends more stringent penalties in cases where narcotics, psychotropics, medical toxic drugs, radioactive drugs, medical precursor chemicals, and injections are misrepresented as other drugs, or the use of alternative drugs to deceive as the aforementioned drugs.

11. NMPA and CDE Release Pharmaceutical Guidelines

In October 2023, NMPA and CDE issued the following guidelines:

5. Chinese Pharmacopoeia Commission Consults on Drafts of Drug Standards

In October 2023, the Chinese Pharmacopoeia Commission released the following draft standards. 

 Contact BaiPharm if you are interested in learning more about drug regulations in China.

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | September 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | August 2023

• Monthly Recap: China Pharmaceutical Regulatory Updates | July 2023