Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022

Editor's Notes: Monthly recap is a collection of China's recent pharmaceutical laws, regulations, policies, and standards, mainly 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.

Contents

1. China NMPA Adds OTC Status to a Former Prescription Drug

2. China NMPA Releases the 62nd List of RLDs

3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety

4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs

5. China CDE Specifies Requirements for Electronic Submission of Drug Applications

6. CDE Issues 8 Guidelines

7. ChP Commission Releases Drafts of Drug Standards

1. China NMPA Adds OTC Status to a Former Prescription Drug

On Dec. 28, 2022, NMPA grants OTC status to Ludangshen Oral Solution. Now the drug has both OTC and prescription (Rx) statuses. China’s OTC drug catalog covers 5,043 drugs.¹ View the full catalog at BaiPharm Database. Learn about Rx-to-OTC switch at BaiPharm’s report.

2. China NMPA Releases the 62nd List of RLDs

On Dec. 28, 2022, NMPA released the 62nd list of 55 reference listed drugs (RLDs), including Actelion’s Bosentan Dispersible Tablets and Novartis’ Siponimod Tablets.² Check all of China’s 5,524 RLDs at BaiPharm Database.

3. China NMPA Issues Regulation on Supervising MAH as the Main Responsible Entity for Drug Safety

On Dec. 29, NMPA issued the Administrative Rules on Supervising Marketing Authorization Holder (MAH) as the Main Entity to Fulfill Responsibilities for Drug Quality (hereafter referred to as the Rules), which will take effect on March 1, 2023. The Rules includes requirements on MAH’s key persons and quality management system.³

Key persons refer to:

1) Responsible person for the corporate;

2) Responsible person for manufacture management;

3) Responsible person for quality management;

4) Qualified person (QP);

5) Responsible person for pharmacovigilance.

Quality management requirements include:

1) auditing suppliers of active ingredients, excipients, and packaging materials;

2) establishing the system for controlling post-marketing changes;

3) establishing product-release protocol;

4) establishing drug traceability system;

5) establishing and improving drug recall system, etc.

Check details at BaiPharm's report "China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality".

4. China NMPA Requires Licenses for Importing and Exporting Anesthetics and Psychoactive Drugs

On Dec. 22, 2022, NMPA and the General Administration of Customs announced that from Jan. 1, 2023, they would require licenses for importing and/or exporting anesthetics and psychoactive drugs. Applicants can apply for the licenses at NMPA’s online service platform or China International Trade Single Window.⁴

5. China CDE Specifies Requirements for Electronic Submission of Drug Applications

On Dec. 2, CDE specified the requirements of all drug application dossiers to be submitted in compact disks. CDE reminded applicants to keep a copy of the disks, because disks with deficient documents will be destroyed by CDE after review rather than sent back to the applicant. CDE also tabulated the structure in which the documents should be organized. The requirements came into effect on Jan. 1, 2023.⁵ Find more details at BaiPharm’s Report.

6. CDE Issues Guidelines

In Dec. 2022, CDE released 8 guidelines:

7. ChP Commission Releases Drafts of Drug Standards

Chinese Pharmacopoeia Commission issued the following drafts of drug standards for comments.

Contact BaiPharm if you need more details of the summarized contents above.

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022

• Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022

• Monthly Recap: China Pharmaceutical Regulatory Updates | September 2022