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.
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.