Coming soon to Chinese pharmacies – more foreign drugs. Staff at a drug store in Shenyang, Liaoning province of China © EPA
China will allow the use of data from overseas clinical trials for approvals of new drugs, in a move likely to enable multinationals to bring products to the world’s second-largest pharmaceutical market more quickly.
Pharmaceutical approvals in China, can take up to seven years longer than in Europe and the US due to a requirement that overseas trials be at an advanced stage before Chinese trials can begin. The China drugs market generated $117bn in sales last year, according to the QuintilesIMS consultancy.
But companies will, in some cases, now be allowed to avoid Chinese trials altogether by using data gathered overseas, the ruling Communist party’s Central Committee said on Sunday.
The move is seen as a boon to multinational pharmaceutical companies, which have seen slowing revenue growth because of Chinese government pressure on drug pricing. They are hoping to sell more innovative drugs to an increasingly affluent population that is struggling with a fast-growing burden of chronic diseases such as cancer.
“This will be a positive factor for the approval of overseas companies’ innovative drugs in China,” said Li Yin of Clarivate Analytics, a research group owned by Thomson Reuters. “The long backlog of products awaiting approval has a chance to be cleared more quickly.”
Wang Lifeng of the Chinese Food and Drug Administration said on Sunday the use of overseas clinical data would be dependent on demonstrating the results were applicable to “eastern” people.
Analysts said specifics of how to meet that requirement have yet to be released, but that it would probably mean including a certain number of people of Asian or Chinese origins in a trial.
Wu Zhen, a drug administration official, said on Monday the previous approval regime meant that about 100 new drugs had been approved in China in the past 15 years, one-third the number in developed countries.
Overseas companies can still experience lengthy delays from approval of their drugs in China to the time they hit the market.
For instance, GlaxoSmithKline became the first company to win approval for a HPV vaccine in China in July 2016, but it was not until 13 months later that it hit the market — by which time a similar product by US rival Merck & Co had also been approved.
Shares of Chinese drugmakers jumped in mainland trade on Monday on hopes that they will also benefit from the regulations, which were bundled as part of a wider drive to boost pharmaceutical innovation. Jiangsu Hengrui Medicine surged as much as 6.5 per cent and Shanghai Fosun Pharmaceutical Group more than 6 per cent.
The move to embrace overseas trial data was foreshadowed in June when China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, an industry body that standardises approval practices.