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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China defines cell therapy as drug with new GMP
Minhua Chu · 01/24/2022
The release of good manufacturing practices for cell therapy this year is an important step in regulating cell therapies.
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China regulates clinical use of innovative oncology drugs, requires biomarker testing
Minhua Chu · 01/06/2022
The new guidelines clarify that some drugs need biomarker testing before prescriptions and listed specific biomarker requirements and recommendations for each drug.
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CDE: Annual Report on Clinical Trials for New Drug Registration in China 2020
PharmaDJ · 12/10/2021
In collaboration with the CDE and Tigermed, PharmaDJ provides an English report offering a glimpse of the new drug registration landscape of 2020.
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China’s latest NRDL excludes foreign PD-1/L1 drugs
Elise Mak · 12/03/2021
Chinese regulators on Friday released the latest National Reimbursement Drug List (NRDL) to reveal which drugs will be reimbursed in the country’s health care system starting January next year. PD-1/L1 drugs from multinational players are excluded from the list this time.
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