In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients.
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Decoding China's Health Insurance & National Reimbursement Drug List (NRDL)
[ Tuesday ,16th May 2023 ]
Introduction to Generic Drug Registration in Singapore
[ Thursday ,6th April 2023 ]
Introduction to Marketing Authorization Regulations in Latin America
[ Thursday ,16th March 2023 ]
2022 Recap & 2023 Outlook: China Pharmaceutical Regulatory Updates
[ Tuesday ,28th February 2023 ]
China Contract Research Organizations (CROs) in Global Landscape China’s contract research organizations (CROs) are developing rapidly, partly demonstrated by its rising revenue. Three China-based CROs—Wuxi AppTec, Pharmaron, and TigerMed—are ranked among the top 10 CROs in terms of 2022’s revenue.
May 26, 2023
Law & Regulation CDE Guideline Pharmacopoeia CMC Clinical Trial Volume-based Procurement Cancer Drug RegistrationMonthly 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
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
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
[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
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
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