China’s drug administration for the first time is considering allowing foreign pharmaceutical companies to conduct clinical trials of new drugs yet to be approved in the country where they were developed, in a bid to reduce waiting times for Chinese patients.
In the future multinationals may no longer be required to have their drugs licensed or have completed the second or third phase of clinical trials on new drugs in their country of origin before they can begin tests in China, according to a draft document released by the China Food and Drug Administration (CFDA) on Friday.
Manufacturers of imported drugs would be allowed to directly apply for market authorization once they have completed international multi-center clinical trials including those in China, the document said.
Chinese patients have long complained about the high cost of drugs and a lack of access to the most recent treatments, and have often resorted to risky gray markets to obtain cheaper medicines. The draft rules are open for public comment until April 20.
Foreign medicines licensed in other countries are required to undergo six to ten months of clinic trials in China before they are allowed in hospitals under current regulations.
Foreign drug companies need to wait for up to five years for official approval before they can produce new drugs in China as opposed to 303 days in the United States, according to a government regulation on approving imported drugs in place since 2003.
The draft rules, if passed, will significantly shorten the time it takes for foreign drugs to enter the world’s fastest growing pharmaceuticals market and it is also likely to push up sales of patented drugs by foreign brands, one analyst said.
International drug makers account for a 23% share of the China market, but patented drugs make up for less than one-fifth of that. This is far below their market share from the sale of patented drugs in other developed countries, the analyst said.
Some inferior quality drugs that don’t perform well in the global marketplace have received a new lease of life in China given the lack of affordable alternatives. If the change goes through, it will also help weed out such drugs from the Chinese market.
In a controversial move, New York-based Bristol-Myers Squibb Co. licensed Brivanib, a liver cancer drug to a Chinese startup in 2013, even though it had stopped global trials after the drug proved to be ineffective compared to other rivals.
The drug has been popular among Chinese patients because fewer alternatives are available, partly due to tight restrictions on foreign drugs. Many critics had earlier raised concerns about whether China was becoming a dumping ground for inferior drugs from multinationals.
The new rules could also have a big impact on domestic drug companies, forcing them to shift towards developing original drugs, according to Shi Lichen, founder of MSKL pharmaceutical consultancy.
“Those that have few R&D resources will lose out amid rising competition,” he said.
By 2020, China will overtake the U.S. as the largest pharmaceutical market, accounting for 7.5% of global sales, according to the consulting company IMS Health.
In a recent interview head of the CFDA Bi Jingquan said the Chinese market had huge potential for multinational drug companies.
His administration increased the number of staff handling drug approval applications last year, cutting the backlog of applications from a peak of 22,000 to 8,000 by the end of 2016.
The CFDA ordered a review of clinical trials for some batches of new drugs including several from multinational companies in July 2015, after a one-year review showed that data from 80% of clinical trials for new drugs were fabricated.
By Wu Jing and Li Rongde