China further simplifies procedures to approve imported drugs

The China Food and Drug Administration (CFDA) said it has further simplified the examination and approval procedures for imported drugs. Under the reform measures, new drugs for rare and fatal diseases are able to directly submit their research filings overseas to the Chinese drug authorities for a quick pass.

Such a green light to imported new drugs will meet the patients’ demand and help address the treatment of rare and fatal diseases, Jiao Hong, deputy chief of CFDA, pointed out at the State Council Information Office (SCIO)’s news briefing.

“Based on our scientific reviews and simplified procedures, we have sped up the examination of new drugs for rare diseases as well as those most needed in clinics including anti-AIDs and anti-tumor drugs. In this way, these new drugs can enter the Chinese market one or two years earlier than expected," said Jiao.

Since mid-April, China has given passes to seven imported drugs, including the much-anticipated nine-valent HPV vaccine. But at the same time, the supervision and review measures will be strengthened to guarantee drugs' safety after they enter the Chinese market. The move follows China's recent removal of imported drug tariffs on all cancer drugs on May 1.

By 2018, more than 3,800 imported drugs have received approval for sales in China, including 3,400 imported chemicals, 300 biotech drugs and over 70 Chinese herbs. It has covered the main medical treatment, such as cancer and high blood pressure. Over the past five years, the average annual number of imported drugs approved for clinical trials has reached 336, with the annual growth rate of seven percent.