China will expedite approval procedures by one to two years for drugs developed overseas that are in urgent demand domestically, an official with the country’s top drug regulator said on June 22.
The National Drug Administration of China will speed up approvals for drugs proved effective in fighting rare diseases as well as anticancer and anti-AIDS drugs, said Jiao Hong, head of the administration.
Jiao told a news briefing hosted by the State Council Information Office that of the 415 new drugs approved for sale in developed countries over the past 10 years, 76 have been approved for sale in China. Another 201 drugs are undergoing clinical trials in China.
In order to fast-track approval procedures, the drug regulator will accept clinical data collected overseas for drugs approved for sale overseas for some life-threatening diseases that are without effective cure, or for rare diseases, she said. There must also be research that proves there is no racial or ethnic difference in response to such drugs.
For drugs that require clinical trials in China, the authority will refine testing procedures to cut the time required before approval, she said.
The authority has also canceled the requirement for inspection of imported drugs at customs, which would enable the drugs to be shipped directly to pharmacies after customs clearance. The authority would instead step up spot checks.
Wang Lifeng, head of the department for product registration for drugs and cosmetics at the administration, said the authority would also enforce a period of data protection for drugs that are developed overseas.
No new drugs of the same category would be approved during the protection period, he said, adding that other measures will also be adopted to protect intellectual property rights.
Jiao said the administration will develop a professional group of inspectors to conduct spot checks during the research, development and production procedures of drugs.
It will also closely monitor cases of adverse reactions for drugs, and suspend their sales or trials, she added.
China is the second-largest market for pharmaceutical products, with a total value of $55.9 billion in 2017, up by 16.3 percent year-on-year, according to the China Chamber of Commerce for Import and Export of Medicines and Health Products.