Monthly Recap: China Pharmaceutical Regulatory Updates | January 2023

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.

The following are the regulatory updates in Jan. 2023:

1. China Issues the 2022 National Reimbursement Drug List

2. China Approves Two Homegrown Drugs for COVID-19

3. China Releases Two Lists of RLDs

4. China Issues GLP Certification Regulation

5. China Rolls Out Pharmaceutical Guidelines

6. Chinese Pharmacopoeia Commission Issues Drafts of Standards

1. China Issues the 2022 National Reimbursement Drug List

On Jan. 18, China’s National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security issued the 2022 National Reimbursement Drug List (NRDL), a list of drugs fully or partially reimbursed by China’s national basic health insurance.

111 drugs entered the 2022 NRDL after bidding or price negotiation between NHSA and pharmaceutical companies. The average price cut reached 60.1%.¹ 

The adjusted NRDL covers 2,967 drugs, including 1,586 western (chemical/biological) drugs and 1,381 Chinese patent medicines. Learn more at BaiPharm News.

2. China Approves Two Homegrown Drugs for COVID-19

On Jan. 28, China NMPA conditionally approved two drugs for COVID-19.

1) Simcere Pharmaceutical Group’s Simnotrelvir Tablets / Ritonavir Tablets (XIAN NUO XIN); 

2) Shanghai Vinnerna Biosciences (joint venture of Shanghai Junshi Biosciences and Suzhou Wangshan Wangshui Biomedicine)' Deuremidevir Hydrobromide Tablets (MIN DE WEI).

Both are approved for treating adult patients with mild-to-moderate COVID-19 infection.²

So far, six drugs have acquired marketing authorization in China for COVID-19 treatment. Read more at BaiPharm News.

3. China Releases Two Lists of RLDs

In Jan. 2023, China NMPA released the 63rd³ and the 64th⁴ lists of reference listed drugs (RLDs), including Eli Lilly’s Verzenios and Chiesi Farmaceutici’s Curosurf. China’s RLD Catalog now covers 5,619 drugs. View the full data at BaiPharm Database.

4. China Issues GLP Certification Regulation

After consulting on the draft in Oct. 2022, China NMPA issued the Administrative Measures for Good Laboratory Practice (GLP) Certification on Jan. 19. The regulation will take effect on July 1, 2023, stipulating that GLP certification is mandatory for institutions that conduct non-clinical safety evaluation studies for drug registration applications in China.⁵

5. China Rolls Out Pharmaceutical Guidelines

In Jan. 2023, China NMPA and its affiliated office CDE published a series of guidelines and adopted some guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

6. Chinese Pharmacopoeia Commission Issues Drafts of Standards

In January 2023, Chinese Pharmacopoeia Commission released the following drafts of drug standards for public comments.

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

Read more:

• Monthly Recap: China Pharmaceutical Regulatory Updates | December 2022

• Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022

• Monthly Recap: China Pharmaceutical Regulatory Updates | October 2022

BaiPharm Monthly Report: New Drug Approvals in China | Jan. 2023

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