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.
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.
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 new guidelines clarify that some drugs need biomarker testing before prescriptions and listed specific biomarker requirements and recommendations for each drug.
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.