The Central Committee of the Communist Party of China and the State Council have new plans to reform the review and approval system for drugs and medical devices.
A slate of suggested amendments to relevant regulatory rules seeks to fulfill the urgent need of advanced medicines and to enhance the innovation ability of the country’s pharmaceutical industry.
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.
“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. “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 the use of overseas clinical data would be dependent on demonstrating the results were applicable to “eastern” people.
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.
Faster approvals could deliver a revenue boost in coming years to Pfizer Inc., AstraZeneca Plc, GlaxoSmithKline Plc and other multinationals that are expanding there. China spent $116.7 billion on medicine in 2016 and the market is second only to the U.S. in size, according to researcher QuintilesIMS. China is revamping its drug regulatory system as demand for new therapies surges due to an aging population and rising incidence of diseases such as cancer and diabetes.
