BaiPharm Pharmaceutical Regulatory News – Mar 07, 2023
Ruiou BaiPharm Service Co.,Ltd’s 7th LinkedIn newsletter, where you'll find the latest pharmaceutical regulatory updates and industry activities in China.
China Marketing Authorization Holder (MAH)'s Responsibilities for Drug Quality
01 March 2023
After?consulting on the draft?in Nov. 2022, China implements?Administrative Rules on Supervising Drug Marketing Authorization Holder as the Main Entity to Fulfill Responsibilities Drug Quality?(hereafter referred to as the?Rules) from?Mar. 1, 2023.
The Rules applies to MAHs in China, requiring them to
-??obey the?Drug Administration Law?and relevant laws & regulations;
-??comply with Good Manufacturing Practices (GMP), Good Supply Practices (GSP),?Good Pharmacovigilance Practices (GVP);
-??establish and improve the drug quality management system;
-??be responsible for the safety, effectiveness, and quality controllability during drug development, manufacture, supply, and use.
The Rules details the drug quality responsibilities in the following aspects:
2022’s Top 10 Cross-border Licensing Deals Involving Chinese Biopharma Companies
24 Feb 2023
Compared with 2021, 2022 was not a thriving year for cross-border licensing deals involving Chinese biopharmaceutical companies.
From 2021 to 2022, the number of in-licensing deals dropped from 128 to 90 with total value slumping from 15.55 billion USD to 5.84 billion USD.?The declines of deal number and value resulted from multiple reasons, including the long-running COVID-19 pandemic, complex international relations, and less financing for biopharmaceutical companies.?
Different from the in-licensing deals, the number of out-licensing deals saw an uptick from 50 to 52. Their total value soared from 15.58 billion USD to 28.09 billion USD. The rise of out-licensing deals reflects that China’s innovative drug and technology have received higher recognition overseas.
Monthly Report: New Drug Approvals in China | February 2023?
03 March 2023
In Feb. 2023, China NMPA approved 13 new drugs, including 9?chemical drugs?and 4?biological products.
领英推荐
Chemical drugs
Biological products
Monthly Recap: China Pharmaceutical Regulatory Updates | February 2023
Mar 07, 2023
1. China NMPA Issues TCM Registration Rules
2. China CDE Rolls Out Pharmaceutical Guidelines
3. Chinese Pharmacopoeia Commission Issues Draft Standards
[Updated] China Adds 111 Drugs to 2022 National Reimbursement Drug List
01 March 2023
On Mar. 1, 2023, China starts to implement the 2022 National Reimbursement Drug List (NRDL) issued by?the National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security in Jan. 2023.?NRDL is a list of drugs fully or partially reimbursed by the national basic health insurance.
TRANSLATION
Chinese Pharmacopoeia 2020 Monograph: Lactose Monohydrate
Lactose is 4-O-β-D-Galactopyranosyl-α-D-glucopyranose monohydrate. It contains not less than 98.0% and not more than 102.0% of C12H22O11, calculated on the anhydrous base. The monograph specifies lactose in terms of the following aspects:
Price: $130