HONG KONG – Lack of proper staffing is the main reason for the huge drug approval backlog at the CFDA, which topped 18,000 applications last year. Though the regulator has plans to reduce the backlog in three years, it is facing other issues beyond the staffing problem. And the shortage of staff compounds other problems such as repetitive applications from generic drug manufacturers and the occasional bout of corruption.

Companies said feedback is rare and applications are often delayed, which slows down the process of getting drugs to the market.

"China's drug regulators lack regular meetings with companies to give feedback," said Fiona Cheng, director of preclinical, clinical and registration at Genor Biopharma Co., the monoclonal antibody and biosimilars arm of biopharmaceutical major Walvax Biotechnology Co. Ltd. "At the same time, their workload is also huge, and on top of that they have other assignments like drafting the biosimilar guideline; so the reviewers have been working overtime a lot."

In one example, a regulatory approval process that took Genor about two years in China only took roughly six months in South Korea. The difference between the CFDA and South Korea's Ministry of Food and Drug Safety had to do with the agencies' communication, staff numbers and the length of the review cycle.

The problem in China is not new, but it is quite a sensitive one for drug companies that have to walk a careful line with the regulator. Almost none was willing to speak on the record, worried that applications could be delayed even further.

Various pharmaceutical company executives told BioWorld Today at the recent Biopharma Asia Convention in Singapore that the problem is a longstanding one. Some drugs that were supposed to be approved last year never got the nod from the CFDA.

As of the end of 2014, the Center for Drug Evaluation (CDE) of the CFDA had 18,597 applications on its waiting list, 4,362 more than at the end of 2013.

BIOLOGICS APPLICATIONS SLOW IN 2014

Biologics made up a small fraction of all applications. The number of applications for biologics declined from 526 in 2013 to 454 in 2014, the first decline in three years. Supplementary biologics applications made up 49 percent of that total and 33 percent were therapeutic investigational new drug (IND) applications.

Almost all types of applications for biological drugs decreased in 2014 with the exception of therapeutic new drugs for which there were 28 applications in 2014, four more than a year earlier. Among the approvals are 12 new biological drugs, including two imported products. The CDE also gave the green light for clinical trials of 110 biological drugs.

All told, through 2014, the CDE completed 5,261 registration approvals, a 13 percent increase from 2013 based on 17 percent more reviews than a year earlier, but that still led to 8,868 more applications being added to the waiting list through the year.

Pharmaceutical companies need to get both clinical trial application (CTA) and IND application approval before marketing a drug. The CDE reviews both and is concerned about the backlog.

TACKLING THE PROBLEM

"Centered on the highlighted backlog problem, the CDE has drafted eight reform schemes including the reform of the technical review management mechanism and the enhancement of reviewing ability," said the CDE in a report published on its website. "The CDE has made a three-year plan to eliminate the backlog."

The CDE's plans include comparing applications and already approved drugs to better distribute resources, building a catalog of repeat applications and training 29 regional reviewers. The CDE also intends to develop new regulations, such as the biosimilar guidelines released last month, as well as hire more staff and develop a network of outside experts that can help speed up the process. (See BioWorld Today, March 5, 2015.)

But the challenges the regulator faces may be more involved than just boosting staff numbers. Executives say there are other considerations for the government. A big one is that slowing down approval helps prevent a spike in demand for expensive new drugs.

"China is not the only country that is doing this; a lot of the European countries are doing it, too," said one pharmaceutical company executive speaking on condition of anonymity.

Still, China's regulator has prioritized areas for faster approvals. Nine therapeutic areas were given priority last year: oncology, vaccines, endocrinology, ophthalmology, digestive system, cardiovascular, reproductive system diseases, anesthesia and analgesia, and antirheumatism.

Oncology was one of the top breakthrough therapeutic areas for Chinese drug developers last year. For example, in January, the CFDA approved China's first-ever orally administrated and subtype-selective histone deacetylase inhibitor, which allowed patients in China with relapsed or refractory peripheral T-cell lymphoma to have an alternative treatment to chemotherapy. Shenzhen-based Chipscreen Biosciences Ltd. is the developer of the cancer drug chidamide, branded Epidaza. (See BioWorld Today, Jan. 14, 2015.)