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To view these presentation slides, please click on DMF Registration in China. Read More

As China’s drug market grows exponentially, more foreign API, excipient and drug packaging material companies look to sell their products in China. In August 2016, to simplify the drug review procedure, the former CFDA announced that the review and approval of APIs,... Read More

Systematic evaluations of the effects of health technologies in Japan, China, and South Korea conducted over the past three years are showing success in determining the clinical benefits and cost-effectiveness of widely used drugs, adjusting pricing of drugs and medical devices and... Read More

Seeking to more effectively manage, distribute and ensure the efficacy of publicly funded vaccines, Chinese health authorities plan to institute a web-based national vaccine tracking system in the next three months. The system, piloted in seven major provinces last year, is designed... Read More

New drug therapies to treat serious and life-threatening diseases would be reviewed more quickly under draft regulations under consideration by China’s Center for Drug Evaluation (CDE). The proposed guidelines would allow for priority review and conditional approval of pharmaceuticals deemed to have... Read More

One month after the Philippines health authorities recommended capping retail prices of 120 needed drugs that are more costly in the archipelago nation than on average elsewhere, major pharmaceutical companies are in talks to reduce prices on some drugs voluntarily. In a... Read More

With the goal of raising the quality and accessibility of its healthcare system to a level commensurate with its position as the world’s second-largest economy, the Chinese government has in the past five years doubled the money it pours into public hospitals... Read More

Less than two years after China first began to prioritize the diagnosis and treatment of rare diseases, the government is ordering hospitals to gather copious data on cases in a bid to promote their diagnosis and treatment. The notification in November 2019... Read More

Moving to improve the safety of clinical trials, China’s Center for Drug Evaluation (CDE) has drafted new regulations on the timing, duration, and manner in which such trials are conducted. Under the new regulations, clinical trials would need to be initiated within... Read More

China’s National Medical Products Administration (NMPA) is seeking public comments on new regulations it is drafting on drug registration, drug distribution, and manufacturing. The new regulations, updated in October by the Ministry of Justice, reflect changes made to the Drug Administration Law... Read More