Drugs developed in other countries are expected to be available for use on the Chinese mainland more quickly under a new guideline released by the central government.
Authorities in China will now accept data collected from clinical trials conducted outside the mainland for applications to register drugs and medical equipment, according to the guideline on reforming approval procedures, which was released by the State Council on Oct 8.
The data must be collected from clinical trials conducted at more than one center and must meet Chinese regulations for registration of drugs and medical equipment, the guideline said.
“The purpose of the measure is to reduce the time needed for approval of drugs from overseas,” Wu Zhen, vice-minister of the China Food and Drug Administration, said on Oct 9.
China’s current drug evaluation and approval system needs improving to expedite the use of new drugs in China, Wu said.
Under current regulations, food and drug authorities cannot accept clinical trial data collected from overseas, and new drugs being developed overseas should finish their first phase of clinical trials overseas before developers can apply to start clinical trials on the mainland, he said.
This has delayed the availability of some major drugs on the Chinese market, he said.
Of 433 drugs approved for sale in developed countries between 2001 and last year, only 30 percent are available on the Chinese mainland.
Over the past 10 years, patients on the mainland have had to wait five to seven years longer for some major new drugs than patients in Europe and the United States, he said.
“This has caused an increasing number of people to buy drugs through the internet and from overseas, which has many potential risks,” he said.
“Recognizing data collected from overseas can reduce unnecessary trials, which reduces the cost of drug research and development and improves Chinese patients’ access to drugs,” said Wang Lifeng, chief of product registration for drugs and cosmetics at the CFDA.
The CFDA will make more detailed regulations to better carry out the guideline, he said.
Meanwhile, the administration will intensify its supervision and inspection of clinical trials conducted overseas, and send inspectors to clinical trial centers overseas for site inspection to ensure that the data collected are accurate, Wang said.
The guideline also bans medical representatives from selling drugs and will hold them accountable if they have done so.