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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
REGULATION
Law & Regulation Guideline Pharmacopoeia CMC Clinical Trial Volume-based Procurement Cancer Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | April 2023 Regulatory updates in Apr. 2023: 1. China Grants Four Rx-to-OTC Switches; China Adjusts Catalogs of Anesthetics and Psychoactive Drugs; China Reveals the 8th Medical VBP’s Bidding Result...
May 15, 2023
INDUSTRY
Marketing Approval Innovative Drug Generic Drug Biological Product Cancer Drug Registration
Monthly Report: New Drug Approvals in China | April 2023 In Apr. 2023, China NMPA approved 13 new drugs, among which 11 are chemical drugs while 2 are biological products.
May 10, 2023
POLICY
Volume-based Procurement Generic Drug
What's New About China's 8th Volume-based Procurement (VBP) of Drugs China's 8th medical volume-based procurement (VBP) covers 39 drugs (number based on generic name) with an average price cut of 56%, estimated to save 1.67 million yuan (circa 240,000 USD) annually based on the planned procurement volumes.
Apr 26, 2023
INDUSTRY
Law & Regulation
Green Development: Not Merely Conceptual, But Compulsory for Pharma Manufacturing in China China is not advanced enough in regulations and technologies for green development, but the good news is that China has been making progress. China tends to turn guidelines into compulsory regulations, including setting up clearer standards for regulating pollution emission.
Apr 19, 2023
REGULATION
Pharmacopoeia
[Updated] China Issues the 2020 Edition of Chinese Pharmacopoeia On Jul. 2, 2020, the National Medical Product Administration and the National Health Commission published the 2020 Edition of the Pharmacopoeia of the People’s Republic of China, which will come into force on Dec. 30, 2020.
Apr 18, 2023
REGULATION
Law & Regulation Guideline Reference Listed Drug (RLD) Marketing Approval Drug Registration
Monthly Recap: China Pharmaceutical Regulatory Updates | March 2023 China regulatory updates in Mar. 2023: 1. China NMPA Grants OTC Status to Two Former Prescription Drugs; 2. China NMPA Releases Two RLD Lists; 3. China NMPA Releases RLD Adjustment Procedures; 4. China CDE Trials Work Procedures for Expediting the Review of Innovative Drug’s Marketing Authorization Application; 5. China CDE Consults on Dossier Requirements for Moving the Manufacturing Site to China...
Apr 13, 2023
INDUSTRY
Marketing Approval Innovative Drug Generic Drug Drug Registration New Drug COVID-19
Monthly Report: New Drug Approvals in China | March 2023 In Mar. 2023, China NMPA approved 15 new drugs, which are all chemical drugs. 1. Raynovent’s Leritrelvir Tablets 2. Shanghai Haihe Biopharma’s Glumetinib Tablets 3. IPSEN PHARMA’s Triptorelin Pamoate for Injection 4. AstraZeneca’s Acalabrutinib Capsules (CALQUENCE) 5. Nobelpharma’s Sirolimus Gel (HYFTOR)...
Apr 07, 2023
REGULATION
Law & Regulation Reference Listed Drug (RLD) Bioequivalence (BE) Generic Drug
China May Delist Ineligible Reference Listed Drugs (RLDs) of Chemical Generic Drugs On Mar. 24, 2023, China NMPA released the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) with immediate effect. RLDs are reference drugs to which generic drugs should be equivalent in safety and efficacy. NMPA finds that some listed RLDs no longer meet the Chinese Pharmacopoeia standards or the current technological requirements. That’s why NMPA formulates and implements the RLD Adjustment Procedures.
Mar 28, 2023
REGULATION
Law & Regulation Guideline Marketing Approval Priority Review NRDL Health Insurance Rare Disease Drug Registration Real World Data
The 16th Rare Disease Day: China's Efforts to Make Orphan Drugs Available and Affordable This year’s Feb. 28 marks the 16th International Rare Disease Day. In China, there are around 20 million rare disease patients, with more than 200,000 additional patients each year. China has shown a supportive attitude towards rare disease drug development in a series of official documents. The regulations and policies introduced in this article are significant in terms of the drugs’ marketing authorization review timeline and pricing.
Mar 10, 2023
REGULATION
Pharmacopoeia EU
EDQM: Supplement 11.2 of the European Pharmacopoeia Available Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.
Mar 09, 2023
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