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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.

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

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

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

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

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

Volume-based Procurement Generic Drug

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

Cancer Rare Disease COVID-19

China Levies Zero Tariff on Active Pharmaceutical Ingredients of COVID-19, Cancer, and Rare Disease Drugs According to China's 2023 Tariff Adjustment Plan, tariffs are provisionally lowered to zero for 22 categories of active pharmaceutical ingredients of medicines for treating COVID-19, cancer, and rare diseases.

Jan 05, 2023

Cancer Rare Disease

China to Cut VAT on the 3rd List of Anti-cancer and Rare Disease Drugs China will reduce the VAT to 3% for a list of anti-cancer drugs and rare disease / orphan drugs from Dec. 1, 2022.

Nov 25, 2022

Volume-based Procurement

China Unveils the Final Drug List for the 7th Volume-based Procurement (VBP) On July 18, China announced the official list of 327 products for the 7th volume-based procurement (VBP).The 327 products are owned by 217 bid-winning companies, which will supply the products to public health institutions. Among the companies, 6 are international enterprises—Hetero Labs, Bracco Sine, Almirall, Sandoz, and Pfizer.

Jul 25, 2022

Volume-based Procurement

327 Drug Products to Enter China's 7th Round of Volume-based Procurement (VBP) Six international pharma companies--Hetero Labs, Bracco Sine, Almirall, Sandoz, Astellas, and Pfizer--won the bid in the preliminary result of the China's 7th round of volume-based procurement (VBP) of drugs.

Jul 15, 2022

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