In China, real-world evidence is playing an increasingly important role in new drug registration
Minhua Chu · 09/08/2022
Hainan’s Medical Tourism Pilot Zone is a pioneer in the practice, with three drugs already approved for market, and seven in the pipeline.
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New rational drug use rules in China benefit pediatric, anti-tumor and anti-infection drugs
Sarina Yang · 08/22/2022
Pediatric drugs see major boom.
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China slaps MAH system on vaccine manufacturing to limit newcomers
Minhua Chu · 08/01/2022
China is set to implement a strict access system for vaccine manufacturing to limit the entry of new vaccine manufacturers, according to a new rule released by the NMPA on July 11 that took effect immediately.
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Chinese regulators clarify factors for picking drugs for reimbursements
Sarina Yang · 06/27/2022
Chinese regulators have shared their considerations on selecting drugs for inclusion in state medical insurance, which should give drugmakers food for thought in terms of their strategy.
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China grants market exclusivity to pediatric and orphan drugs via new drug rules
Elise Mak · 05/23/2022
China’s drug regulators are accelerating the development pathway of pediatric and orphan drugs through revised regulations. Biotech companies that focus on developing these drugs will be rewarded with market exclusivity.
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China’s new regulations on human genetic resources set to speed up R&D
Minhua Chu · 04/21/2022
Though China still requires that foreign companies seek approval before using human genetic resources (HGR) in their clinical trials, a new regulation is relaxing the definition of ‘foreign entities’ and clarifying when approval is needed. This is intended to make it easier for biotech firms to start clinical trials.
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China’s CDE offers assistance and encourages communication for breakthrough therapy reviews
Minhua Chu · 03/28/2022
China’s CDE has told drugmakers to communicate more with them and will offer guidance for breakthrough therapy applications.
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China’s CDE issues new guidelines for COVID-19 drug trials
Minhua Chu · 02/28/2022
The CDE issued a new batch of guidelines that covers the subjects, primary endpoints and design of clinical trials for COVID-19 drugs. The move came six days after the NMPA granted conditional approval for Pfizer's Paxlovid.
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China encourages real-world data, cell and gene therapy in Shenzhen
Elise Mak · 02/09/2022
Chinese authorities are encouraging the use of real-world data in clinical evaluation, easing regulations on human genetic resources, and welcoming more biotech services providers in Shenzhen, according to the policy incentives unveiled last month.
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