The Chinese government on Sunday announced measures to speed up and simplify approval procedures for overseas drugs and medical devices entering China, as part of the country’s drive to support innovation in the domestic industry.
The move could be a boon for foreign companies that have long hoped for greater access to the vast Chinese market, as it could help them cut costs and improve efficiency, industry experts said.
The State Council, China’s cabinet, announced late on Sunday that foreign drug trial data would be accepted in the country, a move aimed at speeding up approvals and helping China shorten an innovation gap with developed markets across the globe, the Xinhua News Agency reported, citing a policy statement.
Clinical trial data obtained from overseas centers that comply with Chinese drug and medical device registration requirements can be used in registration applications with the Chinese government, the statement said.
Pharmaceutical firms that are pursuing registration for drugs or medical devices for the first time should provide clinical trial data on different races, according to the statement.
“The changes aim to reduce repetitive trials, lower research and development costs and improve efficiency [for firms entering] the Chinese market,” Wang Lifeng, an official with the China Food and Drug Administration, told a press conference held in Beijing on Monday.
The move will benefit both foreign companies and domestic innovative enterprises that seek growth in the global market, Wang said, noting that accepting clinical trial data carried out in foreign markets is an international convention, but is restricted by certain conditions.
“The authorities are expected to strengthen supervision of foreign clinical tests through efforts like setting up an overseas clinical trial examination system to guarantee data accuracy,” Wang noted.
The reform will likely reduce delays for new medicines in entering the domestic market and will potentially benefit Chinese patients as well, experts said.
“Previously, clinical trial data carried out overseas was not accepted in China. Thus, international drug makers had to repeat the trials if they wanted to bring new drugs and medical devices into the Chinese market, which could take several years,” Wang Yingtao, head of the Beijing representative office for Germany-based dental material manufacturer DMG, told the Global Times on Monday.
“The changes will help foreign drug makers save time and costs, as well as improving the efficiency of bringing the latest products and devices into China,” Wang of DMG said.
A sales director for Schiller China who only gave his name as Frank said that the reform would accelerate the registration process for foreign medical devices in the Chinese market.
“Therefore, the prices of drugs and medical devices from overseas will fall,” he said.
“It is also a potential benefit for Chinese patients, because delays in approvals for new treatment will be cut by several years,” said Wang of DMG.
China’s support for scientific innovation in medicine has been insufficient and the quality of pharmaceutical products in the Chinese market still lags behind advanced global levels, the State Council statement said.
The changes will help boost the domestic drug sector by adjusting the industrial structure, encouraging innovation and making Chinese drug makers more competitive, experts said, noting that the Chinese drug industry has huge growth potential.
In 2016, China overtook Japan to become the world’s second-biggest pharmaceuticals market, in terms of spending by patients and the government on drugs, second only to the US, media reports said.
China’s pharmaceutical industry sales reached 1,704 billion yuan ($257 billion) in 2016, an increase of 8.9 percent on a yearly basis, according to data released by DBS Group Research in May.
Although domestic drug makers will face intensified competition from their foreign counterparts in the short term, they can take this chance to strengthen their competitive competence by learning from foreign advanced technology, said Frank.
Source: Global Times