Pharmaceutical
ChemLinkedMarketChemicalFoodCosmeticPharmaceuticalJapanAgrochemicalSustainability
News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
POLICY
NRDL Health Insurance New Drug COVID-19
[Updated] China Publishes the Preliminary List of Drugs for 2023 National Reimbursement Drug List (NRDL) On Mar. 1, 2023, China starts to implement the 2022 National Reimbursement Drug List (NRDL), a list of drugs fully or partially reimbursed by the national basic health insurance.
Sep 04, 2023
POLICY
Drug Registration
Zhou Siyuan Nominated as China Center for Drug Evaluation's New Director China’s Center for Drug Evaluation (CDE) recently revealed a change in its leadership—Zhou Siyuan replaces Kong Fanpu as the new director. As an office under the National Medical Products Administration (NMPA), CDE is mostly known for its function of conducting technical review/evaluation of drug registration applications.
Aug 30, 2023
POLICY
Marketing Approval Drug Registration Pediatric Drug
China Encourages Pediatric Drugs' Development and Marketing Authorization On Aug. 23, 2023, China released the 4th List of Pediatric Drugs Encouraged for Development and Marketing Authorization. The list contains 24 drugs, involving 30 strengths, 9 dosage forms, and multiple therapeutic areas such as nervous system diseases, gastrointestinal system, metabolic disorders, tumors, and immune disease.
Aug 24, 2023
PIPELINE
Biological Product Cancer Cardiovascular Disease License in/out
[Updated] Biopharma Licensing Deals Involving Chinese Companies in H1 2023 H1 2023 witnessed 45 biopharmaceutical licensing deals of which one side is Chinese companies. Among the deals, 15 are licensed to Chinese mainland stakeholders and 30 vice versa.
Aug 23, 2023
POLICY
Drug Registration Thailand
Thai FDA Expedites Drug Import Via Digital Channel On Aug. 17, 2023, Thai Food and Drug Administration (FDA) announced the policy for expediting the import of healthcare products, including drugs, medical devices, food, and cosmetics, with the aid of a digital service.
Aug 18, 2023
REGULATION
Law & Regulation MAH GMP Post-market
Outsourcing Manufacture: Regulatory Considerations for Drug Marketing Authorization Holders (MAHs) The drug marketing authorization holder (MAH) system has been effective in China since the revised Drug Administration Law went into force in 2019. The system entitles MAHs to entrust other companies with the manufacturing activities. Thus, quite a few MAHs outsource manufacture to other companies, and save more resources for R&D or other areas.
Aug 17, 2023
REGULATION
Law & Regulation Guideline Pharmacopoeia Reference Listed Drug (RLD) GMP CMC Clinical Trial Bioequivalence (BE) Cell Therapy Gene Therapy Drug Registration GLP GSP
Monthly Recap: China Pharmaceutical Regulatory Updates | July 2023 China pharmaceutical regulatory updates in July 2023: 1. China Publishes Administrative Measures for Drug Standards; 2. China Announces Customs Codes of Anesthetics and Psychotropic Drugs; 3. China Rolls out the 70th RLD List; 4. China Grants Four Rx-to-OTC Switches; 5. China Revises Drug Inspection Regulation; 6. China Issues Draft Regulation on Inspection of Clinical Trial Institutions; 7. China Releases Pharmaceutical Guidelines; 8. China Consults on Drafts of Drug Standards
Aug 11, 2023
REGULATION
Law & Regulation GMP
Drug Inspections of Manufacturers and Suppliers in China: Regulation Revised China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Aug 11, 2023
INDUSTRY
Marketing Approval Priority Review Generic Drug Diabetes Drug Registration New Drug
Monthly Report: New Drug Approvals in China | July 2023 In July 2023, China NMPA approved 5 new drugs, among which 3 are chemical drugs and 2 are biological products.
Aug 03, 2023
REGULATION
Law & Regulation Clinical Trial Medical Device
[Updated] China Exempts Eligible Medical Devices and IVD Reagents from Clinical Evaluation or Trials On July 24, 2023, China NMPA announced the revised List of Medical Devices Exempted from Clinical Evaluation (2023) with immediate effect.
Jul 27, 2023
Pre 1... 34567 ...25 Next
Most Popular