China's top food and drug authority is soliciting public opinion for a draft plan to hasten the process of approving foreign drugs to be sold in the Chinese mainland, a move hailed by experts as both beneficial and challenging to the country's drug industry.
The draft plan states that pharmaceuticals can directly apply to register new drugs if the drugs have passed the International Multicenter Clinical Trial (IMCT) in China.
Previously, new drugs had to wait until they were introduced to other markets before being imported to China, which took five or six years, Song Ruilin, executive president of the China Pharmaceutical Industry Research and Development Association, told the Global Times.
A drug will also no longer require registration outside of Chinese mainland or enter into a second or third phase of clinical trials in other countries before undergoing IMCT in China, said the draft plan released on the China Food and Drug Administration (CFDA)'s website on Friday.
Obtaining a drug approval in the country where the manufacturer is located has likewise been cancelled for new drugs and therapeutic products, said the draft.
The changes were made in response to public demand for new drugs, said the draft plan on adjusting the registration and management of imported drugs. The public can submit their opinions before April 20.
The policy will likely shorten the review period to as short as 10 months, said Song, adding that it will also help China research on and develop more new drugs itself that are competitive in the international market, instead of merely being a follower.
More new drugs from the US, Japan and European Union would be brought into China more quickly, and India, which is famous for its generic medicine, would also benefit from the policy, said experts.
A Chinese leukemia patient suspected of helping fellow patients gain access to cheaper foreign drugs was arrested in Beijing before prosecutors withdrew charges in 2015 that he allegedly peddled counterfeit drugs and engaged in credit card fraud.
Drugs urgently needed in China, such as metabolic and antibiotic drugs, as well as those used to treat cancers, will be given priority if the draft is adopted, Wang Shuguang, executive partner of the GTJA investment group, a Shenzhen-based private equity company involved the healthcare industry, told the Global Times.
The plan will also weed out some domestic drug producers, if more advanced foreign drugs enter China, said Wang.
Apart from a streamlined review process, China has also been training more reviewers of imported drugs, with the number rising to 600 by the end of 2016, CFDA head Bi Jinquan was quoted as saying by news site cnr.cn on Saturday.