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.
China’s CDE has told drugmakers to communicate more with them and will offer guidance for breakthrough therapy applications.
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.
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.
The release of good manufacturing practices for cell therapy this year is an important step in regulating cell therapies.
The new guidelines clarify that some drugs need biomarker testing before prescriptions and listed specific biomarker requirements and recommendations for each drug.
In collaboration with the CDE and Tigermed, PharmaDJ provides an English report offering a glimpse of the new drug registration landscape of 2020.
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.