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Expertise Pharmaceutical ChemLinked Market Chemical Food Cosmetic Pharmaceutical Japan Agrochemical Sustainability LOG IN SIGN UP LOG IN Home News Insights Database Events Webinars Offline Events Services Home News Insights Database Regulatory Database Drug Catalog ChP Standards Events Webinars Offline Events Services Search OUR SERVICE In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients. Drug Application E-commerce Solutions Pharmacovigilance Consulting and Training WEBINARS MOREA Look Back at 2023: Pharmaceutical Regulatory Updates in China [ Tuesday, 30th January 2024 ] Understanding Regulatory Requirements for Exporting Drugs to Cambodia, Laos, and Myanmar [ Wednesday, 13th December 2023 ] Understanding Regulatory Requirements for Exporting Drugs to Indonesia and Vietnam [ Thursday, 30th November 2023 ] Malaysia Pharmaceutical Regulatory Pathway [ Tuesday, 7th November 2023 ] LATEST NEWS INDUSTRY Innovative Drug Biological Product OTC Drug Drug Registration New Drug Monthly Report: New Drug Approvals in China | April 2024 In April 2024, China NMPA approved 27 new drugs, among which 18 are chemical drugs and 9 are biological products. May 15, 2024 REGULATION Law & Regulation Pharmacopoeia Reference Listed Drug (RLD) Marketing Approval OTC Drug Monthly Recap: China Pharmaceutical Regulatory Updates | April 2024 Check out the latest pharma regulatory updates in China: 1. China NMPA Adopts Electronic Documentation for Administrative Licensing in Drug Registration, 2. China NMPA Rolls out the 79th RLD List, 3. China Enhances Supervision and Management of Drug Operations, 4. China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China... May 13, 2024 REGULATION Law & Regulation Innovative Drug Drug Registration China Releases Dossier Requirements for Imported Chemical Drugs Transfer to Domestic Production On May 9, China CDE released the Dossier Requirements for Marketing Authorization Applications of Approved Imported (Chemical) Drugs to Be Transferred to Domestic Production. May 11, 2024 INDUSTRY Clinical Trial CRO [Updated] Top 10 CROs With the Highest Revenues in 2023 In 2023, most contract research organizations (CROs) on the top 10 list of the highest revenues experienced modest growth rates of less than 5%. Two CROs—Syneos and Catalent even saw a decline in their revenues. Only Lonza and Samsung Biologics achieved year-on-year growth of over 10%. Apr 30, 2024 PIPELINE Biological Product Cancer Cardiovascular Disease License in/out [Updated] Pharma Licensing Deals Involving Chinese Companies in 2023 In 2023, the Chinese pharma industry witnessed a total of 124 licensing deals, with a combined transaction value of USD 50.59 billion. Compared to the previous year, the transaction value of licensing deals in 2023 increased by 41% year on year, while the number of deals decreased by 38%. Apr 29, 2024 REGULATION Law & Regulation Marketing Approval Priority Review Drug Registration [Updated] China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China The draft brings encouraging news as it suggests that China may accept the original registration application dossier of overseas drugs, including documents related to chemistry, manufacturing, and controls, non-clinical and clinical studies, if they remain applicable. Apr 24, 2024 REGULATION Generic Drug API Drug Registration China Consults on Self-Evaluation Report Guidance for Generic Drug Registration On April 2, 2024, China’s Center for Drug Evaluation (CDE) released the two drafts of Chemical, Manufacturing, and Controls (CMC) Self-evaluation Reports on Class 3 Chemical Drug Registration Applications, one for drug substances, and the other for drug products. Apr 15, 2024 REGULATION Law & Regulation Pharmacopoeia Reference Listed Drug (RLD) OTC Drug Monthly Recap: China Pharmaceutical Regulatory Updates | March 2024 Check out the latest pharma regulatory updates in China: 1. NMPA Rolls Out the 78th RLD List; 2. NMPA Grants Six Rx-to-OTC Switches; 3. NMPA Implements Electronic Submission for Import and Export License Applications of Anesthetics and Psychotropics; 4. NMPA Issues Regulation on Exploratory Research on Drug Sampling and Testing... Apr 12, 2024 MOREINSIGHTS MOREDecoding China’s Good Pharmacovigilance Practices (GVP) 2023 China CDE Drug Evaluation Report China’s Drug Supply Regulations Come into Effect SIGN UP FOR OUR NEWSLETTER to keep updated with China’s pharma regulatory news and events Subscribe Name * Company * Email * Message * Cancel Get in Touch Now BaiPharm is a sub-portal of ChemLinked, offering the latest pharmaceutical news, in-depth analysis and professional consultancy services. 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