For decades in China, patient access to overseas developed innovative drugs has been partially hampered by the requirement that data be supplied from clinical trials conducted in China (this after the innovator had already completed multiple phases of clinical trials in their country of origin). Unfortunately, this requirement adds significantly to the time period for approval which can often take as long as eight years. As a result, China’s Food and Drug Administration (CFDA) has a tremendous backlog of drug approval applications which, in June, stood at 6,000 (compared to a high of 22,000 in 2015). As a result, between 2001 and 2016, regulators in developed markets approved 433 new drugs whereas China approved just over 100. Taken together, all of this helps explain why a new drug often appears on the market in China anywhere from five to seven years later than in Europe or the U.S.
Earlier this month, the General Office of the Communist Party of China Central Committee and the General Office of the State Council issued a guideline that allows data from overseas clinical trials to be used directly in the innovative drug and medical device application process. The guideline notes that companies looking to register innovative drugs or medical devices will need to provide clinical trial data related to any racial divergence relevant to the Chinese market. Regardless, this change is significant and should considerably shorten the time period for approval of future drugs by several years. However, one concern is that the guideline did not set a timetable for implementation.
The guideline also includes other measures to speed up approvals for clinically needed drugs and equipment, establish a compulsory licensing system and to make it easier for research institutions to conduct clinical trials. Additionally, the Chinese government has said that it is also exploring a new system linking drug approvals to patent status (a patent linkage system).
This announcement comes as China aims to boost its drug industry and shift from generic drugs towards more innovative medicines and medical equipment. China has the second largest drug market next to the U.S. The changes proposed by the guideline are intended to make China’s industry more competitive and help meet the clinical needs of its nearly 1.4 billion people, for whom high costs and access to health care are significant issues.
This post was written by Lisa Mueller.