Policy / Regulatory

Five Innovative Therapies Enter the Rare Disease R&D Pilot Initiative – Spanning Blau Syndrome, Angelman Syndrome, ALS and Charcot‑Marie‑Tooth Disease
CDERare / orphan disease drugs

Five Innovative Therapies Enter the Rare Disease R&D Pilot Initiative – Spanning Blau Syndrome, Angelman Syndrome, ALS and Charcot‑Marie‑Tooth Disease

Accropeutics, Anyea, Myrobalan Therapeutics and ReviR Therapeutics announced that AC‑101, ANY‑108, ANY‑112, MRO‑001HS and RTX‑117 have been admitted into the pilot initiative encouraging the research and development of innovative therapies…

China's CDE Launches "Pioneer Plan" Pilot to Advance New Approach Methodologies (NAMs) in Non‑Clinical Drug Evaluation – Aiming to Reduce, Refine, and Replace Animal Testing

China’s CDE Launches “Pioneer Plan” Pilot to Advance New Approach Methodologies (NAMs) in Non‑Clinical Drug Evaluation – Aiming to Reduce, Refine, and Replace Animal Testing

China's NMPA Unveils Draft Regulations on Radiopharmaceuticals – Public Consultation Open Through October 20 With Priority Review for Urgent‑Demand Products

China’s NMPA Unveils Draft Regulations on Radiopharmaceuticals – Public Consultation Open Through October 20 With Priority Review for Urgent‑Demand Products

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Three Oncology Assets Join CDE Pilot Programs – ICP‑B794 and Aponermin Enter "Care Program – Extension" While GH56 Advances Pediatric Development
CancerPediatric drugs

Three Oncology Assets Join CDE Pilot Programs – ICP‑B794 and Aponermin Enter “Care Program – Extension” While GH56 Advances Pediatric Development

China Orders Whole‑Class Listing of "Orphine‑Type Substances" in Non‑Medicinal Narcotic and Psychotropic Catalogue – Tri‑Agency Control Takes Effect 1 October 2026
NHC (NHFPC)NMPA

China Orders Whole‑Class Listing of “Orphine‑Type Substances” in Non‑Medicinal Narcotic and Psychotropic Catalogue – Tri‑Agency Control Takes Effect 1 October 2026

NMPA Releases 109th RLD Catalog for Chemical Generics – 30 New Product Specifications Added, 24 Supplemented
GQCE testing

NMPA Releases 109th RLD Catalog for Chemical Generics – 30 New Product Specifications Added, 24 Supplemented

US Treasury Drafts China Pharma Investment Rules Likely to Preserve Licensing Deals – A Carve‑Out From Broader National‑Security Tightening

US Treasury Drafts China Pharma Investment Rules Likely to Preserve Licensing Deals – A Carve‑Out From Broader National‑Security Tightening

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