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In all critical stages in the drug life cycle, BaiPharm can provide specific recommendations and actionable solutions to clients.

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Pharmacovigilance
Consulting and Training
WEBINARS MORE >
webinar cover Marketing Authorization and Regulatory Requirements for Exporting Drugs to Thailand
[ Wednesday ,25th October 2023 ]
webinar cover China Pharmacovigilance (PV) Regulation Evolution and Digital PV Solution in Practice
[ Thursday ,29th June 2023 ]
webinar cover Decoding China's Health Insurance & National Reimbursement Drug List (NRDL)
[ Tuesday ,16th May 2023 ]
webinar cover Introduction to Generic Drug Registration in Singapore
[ Thursday ,6th April 2023 ]
LATEST NEWS
POLICY
Rare Disease
China Releases the 2nd Catalog of Rare Diseases On Sept. 20, 2023, China released the 2nd Catalog of Rare Diseases, which comprises 86 rare diseases across various medical specialties including hematology, dermatology, rheumatology & immunology, pediatrics, neurology, and endocrinology.
Sep 21, 2023
REGULATION
Law & Regulation
China Adjusts Anesthetic and Psychotropic Drug Catalogs On Sept. 11, 2023, China’s National Medical Products Administration (NMPA), Ministry of Public Security, and National Health Commission (NHC) adjusted the Catalogs of Anesthetics and Psychotropic Drugs.
Sep 12, 2023
REGULATION
Law & Regulation MAH Marketing Approval Clinical Trial Post-market Drug Registration
[Draft Regulation] China to Become Stricter on Conditional Approval of Drugs On Aug. 25, 2023, China National Medical Products Administration (NMPA) released the revised draft of Work Process for Conditional Approval of Drug Marketing Authorization Applications (Trial).
Sep 11, 2023
INDUSTRY
Law & Regulation Guideline Pharmacopoeia Reference Listed Drug (RLD) OTC Drug
Monthly Recap: China Pharmaceutical Regulatory Updates | August 2023 China pharma regulatory updates in Aug 2023: 1. China Consults on Conditional Approval Process; 2. China Rolls out 71st and 72nd Lists of RLDs; 3. China Grants Two Rx-to-OTC Switches; 4. China Releases Pharmaceutical Guidelines; 5. China Consults on Drafts of Drug Standards
Sep 08, 2023
INDUSTRY
Marketing Approval Innovative Drug Generic Drug Biological Product Drug Registration New Drug
Monthly Report: New Drug Approvals in China | August 2023 In Aug. 2023, China NMPA approved 17 new drugs, among which 14 are chemical drugs and 3 are biological products.
Sep 07, 2023
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
MORE >
INSIGHTS MORE >
cover 2022 China CDE Drug Evaluation Report
cover For Injectable Complex Generics, China Has Special CMC Requirements
cover China DMF Requirements for CMC Post-approval Changes to Chemical Drugs
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