China's reforms aim to speed drug approvals

HONG KONG – China is speeding up approval times and improving the review process for domestic and imported drugs. The ultimate aim of a series of reforms recently announced by the State Council, akin to the cabinet, is to develop a faster and better approvals system that rewards innovation.

The CFDA plans to release regulations in the near future and actual implementation could take some time, but the reform should ultimately substantially change the registration process for drugs and medical device in China and drive innovation.

In a series of policy reforms announced this week, China's State Council set out to speed up approvals for drugs and medical devices, in particular those that go through the international multicenter clinical trials.

"The reform means faster approval decision, higher drug quality and more professional staff," said Michelle Zhang, senior analyst at Moody's Investor Service. "This will have a very positive effect on strong companies focused on innovation, many of the backlog applications are for novel products."

"Whatever the size of a company, if it lacks innovation, the reform will pose a big challenge for it," said Zhang.

The State Council listed five major goals for this round of reform:

• • increase the quality of drug and medical device evaluations;
• • raise controls on products to world-class levels;
• • clear a backlog of registration applications;
• • speed up the conformance of generic and originator drugs;
• • and encourage the development of fast track approval novel drug development, open approval fast lanes for key innovations; make the approval process more transparent to the public.

At a press conference on Tuesday, CFDA Deputy Director Wu Zhen highlighted that China will start accepting cross-border multicenter clinical trials.

"This makes a huge difference. . . . We will be able to adopt data from these trials as well. . . . This will solve our slow import problem," Wu said.

The CFDA has traditionally asked for efficacy and safety data from clinical trials conducted on Chinese people. That requires additional time-consuming trials. Those trials combined with the backlog in processing applications can translate into long delays in approvals for innovative imported drugs, delays that are often between five and eight years. Companies are typically asked to apply for later-stage clinical trials in China after they've finished the previous trials in other countries to ensure safety.

CLEARING THE BACKLOG

By the end of last year, the Center for Drug Evaluation had 18,597 applications on its waiting list, according to a report that the CFDA released in March. (See BioWorld Today, April 1, 2015.)

Clearing up this backlog has emerged as a priority for regulators.

"The CFDA is dealing with 21,000 applications at the moment," said Wu. "Compared with our reviewing ability now, this is a very big work load."

The CFDA took over all the reviews that were once done by provincial agencies in the year 2000 and backlogs have surged several times. The number of applications in the pipeline has surged three times since then to 17,000 in 2005, 27,000 in 2008 and 21,000 last year.

The CFDA now has some 120 reviewers dealing with 8,000 to 10,000 applications. Every reviewer has to take on 40 to 50 cases to finish reviewing half of the applications sent every year. In addition, the salaries of reviewers are typically lower than those for similarly qualified staff at private enterprises or R&D institutes, so the loss of talent is a hurdle for the CFDA as well.

To deal with the problem, the CFDA is actively searching for staff. The agency is also starting to outsource some of its work: working with reviewing organizations, universities and R&D institutes to participate in the evaluation of generic drugs, clinical trials, drug safety and medical devices.

The CFDA aims to clear the backlog by the end of 2016 with the new mechanism after implementing all the measures from the reform. It also hopes to see a balance between applications and approvals by 2017 and have a relatively healthy system the year after that.

Speed is one concern for regulators. Another is quality.

Wu said there are some hiccups in the current approval system. One is that the CFDA, a national level agency, is responsible for evaluating drugs but it still needs help from provincial or local FDAs in areas like on-site inspection, product tests and first reading of application documents.

"The performance of each province's reviewing varies a lot," said Wu. "Some parts of the country have looser standards, which creates barriers."

"We also have some unreasonable regulations such as restricting approvals to companies," Wu added. "So innovators have no choice but to transfer their discovery to companies, which has led to less enthusiasm for innovation."

The CFDA also plans to work on improving the quality of generics in the market through stricter requirement for proof of bioequivalence between generic and originator drugs. The additional test will cost pharmaceutical companies more but Wu is confident that it won't largely affect the market because it ensures higher quality and costs remain relatively low.

"If we raise the bar for new drugs higher, the generics will have to catch up with the originators, and there will be fewer [repetitive and low-quality] applications," said Wu.

"To get good products approved more quickly and pick out the poor ones, we are drafting some specific measures on accelerating drug evaluation process now," he added. "We'll be soliciting public opinion on that very soon."

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