Backlog in drug approvals reduced

The backlog of drug registration cases in China has been substantially reduced, with 9,000 applications awaiting approval, compared with a peak of 22,000 last year, a senior official said.

“Reforms are underway to speed up the drug evaluation and registration process to improve public access to advanced treatments,” said Li Jinju, deputy director of the China FoodandDrugAdministration’s drug and cosmetics registration department.

“But safety and quality will never be compromised,” Li said.

A shortage of staff in drug evaluation and registration is mainly to blame, she said. “That was addressed by the reforms.”

There are about 10,000 applications for drug registration per year.

Safety and quality will never be compromised.”

Li Jinju,

deputy director of the China Food and Drug Administration’s drug and cosmetics registration department

Before 2015, the administration’s drug evaluation center had only 130 staff, including 80 specializing in drug evaluation, Li said. In comparison, a similar department in the United States has 5,000, and in Japan there are 700.

Under the reforms, “we hired more, but it takes time to build capacity and train staff as the evaluation work is highly demanding technically”, she said.

The strain is expected to be substantially relieved in two to three years, she estimated.

Also, new drugs in urgent and high demand clinically will be fasttracked for approval, she added.

So far, 146 candidates have been fast-tracked for registration and approval, including the HPV vaccine, which protects women from cervical cancer caused by HPV infection and was submitted for approval about 10 years ago.

To enhance efficiency, other reform measures like strengthened communication with drug developers and streamlined interior working procedures were introduced as well after March, she said.

In March, Bi Jingquan, head of the administration, first pledged reforms of drug registration to beef up efficiency.

He recognized that the process took longer in China and that “there was a backlog of cases”.

In China, a drug candidate needs to go through applications, three phases of clinical trials, and registration and approval to become available for patients, a process that can take years.