Drugmakers applaud accelerated approvals

China is approving foreign drugs at a record speed, which industry sources said shows the country’s commitment to further opening up its healthcare sector and supporting innovation.

Since 2016, the country has adopted a series of policy amendments to speed up new drug approvals, as part of its widespread reforms in healthcare, opening-up, and improving market access.

A statement issued after the annual Central Economic Work Conference in December said China will work to promote technological innovation and foster new industrial clusters, and build a unified and open market system with orderly competition.

It also said that micro market entities will be further motivated and energized, with the establishment of fair, open and transparent market rules and a law-based business environment.

“China is opening up its lucrative pharmaceutical market to the outside world with a determination never seen before,” said Liu Guoen, an economist and healthcare reform specialist with the National School of Development, Peking University.

“The accelerated approval and a more open market are good for everyone,” he added.

Widely acclaimed reforms in the drug regulation system in recent years include fast-track approval for treatments addressing severe or rare diseases, acceptance of global clinical trial data, and fast and easy access to clinical trial registration.

More than 100 foreign-developed drugs were approved for the Chinese market in 2018, according to a report released in December by global management consulting firm McKinsey and Co.

In another report released in May 2018, the consulting giant described the reforms as being “in full stride” and said there would be “a tsunami of new-product launches expected”.

It observed a record number of approvals and new product launches in 2017: a total of 37 new products versus a mere five or six between 2014 and 2016.