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Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
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REGULATION
China Rolls Out Measures to Establish Drug Patent Linkage System
China tries to balance the patent protection of innovative drugs and the development of generics. MAHs of innovative drugs can bring a lawsuit or apply for an administrative ruling to protect patents. The first generics that successfully challenge the registered innovative drugs can enjoy 12-month marketing exclusivity.
Jul 23, 2021
REGULATION
Monthly Recap: China Pharmaceutical Regulatory Updates | June 2021
The monthly recap is intended to bring you the dynamics of recent major laws and regulations issued by China drug regulators, including National Medical Products Administration (NMPA) and the Center for Drug Evaluation (CDE).
Jul 20, 2021
INDUSTRY
China Approves First Domestic CAR-T Therapy
Fosun Kite's Axicabtagene Ciloleucel recently received marketing authorization by NMPA, becoming the first CAR-T therapy approved in China. The Chinese CAR-T industry is thus eyeing a promising future, but the road to market success is challenging.
Jul 12, 2021
POLICY
A Record Number of Foreign Companies Wins the Bidding for China's Latest Drug Procurement
251 products from 148 companies won the bidding on June 23 in Shanghai for the latest and fifth round of China’s national centralized drug procurement. The bidding saw some record numbers. One of them is the unprecedented number of 10 international pharma companies successfully earning places in the procurement program.
Jun 30, 2021
REGULATION
China Takes New Measures for GMP & GSP Inspection
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).
Jun 15, 2021
POLICY
China to Pilot Cross-Border E-Commerce Retail Import of Drugs
China recently approved Henan Province’s cross-border e-commerce pilot program for importing drugs and medical devices, starting with 13 OTC medicines licensed in China. Thanks to the pilot program, more overseas drugs, including anti-cancer and targeted therapy drugs, stand a chance of accessing the Chinese market. This article focuses on drug import as part of the pilot program.
Jun 04, 2021
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