China plans to speed up the approval process for innovative medicines, a development that would aid multinational companies seeking to bring their newest drugs to world’s the most populous nation.
Companies can apply to expedite approvals for urgently needed new drugs as long as their prices aren’t higher than in the originating country or comparable markets, according to guidelines issued by China’s State Council on Tuesday. Clinical trial regulations for newly developed drugs will also be eased.
Foreign pharmaceutical companies often have to wait years to bring new treatments to China due to the country’s lengthy approval process. In the past, multinationals could apply to import a drug only after it had been approved and marketed in another country. They were then also required to conduct trials on Chinese patients.
Foreign companies will now be able to conduct clinical trials in China simultaneously with overseas trials. Drugmakers will also be able to use data from international clinical trials to apply to import their products into China.
“Our attitude is very clear, we welcome innovative drugs to China, to come early, the sooner the better,” Wu Zhen, vice minister of the China Food and Drug Administration, said at a press conference in Beijing.
Innovative drugs including those for AIDS, cancer, major infectious diseases and rare illnesses are eligible for expedited review and approval. China aims to eliminate its backlog of drug applications by the end of 2016, according to the guidelines. Currently, the administration has about 21,000 applications awaiting review and approval, and a staff of 120 to do the job, said Wu.
Last year, foreign pharmaceutical companies in China expressed concerns that regulatory delays would push back plans to introduce their latest drugs into the country by up to two years.
— With assistance by Hui Li, and Aipeng Soo