China’s FDA aims to speed drug OKs with shift to U.S.-style clinical trial application process

To foster new trial sites, the Agency is backing away from it’s certification system, which requires any facility that wants to conduct clinical trials to go through a laborious certification process.  And to speed up trial approval — and probably improve the country’s position in international clinical studies — the agency is proposing a “no response means approval” mechanism.  Akin to the U.S. FDA’s trial approach, the new policy would cut the waiting time for researchers starting new studies.

Clinical trial approval vs. 60 working day response

As part of a series of changes posted online on May 11, the CFDA proposes (Chinese) to change it’s clinical trial approval system to one similar to the U.S. FDA’s Investigative New Drug (IND) process.  Under current rules, a drug company must wait for the CFDA’s official go-ahead before beginning a clinical trial.  The new proposal, however, would give the Agency 60 working days to either reject or question a trial application.  Otherwise, the application would automatically be considered a go.

Although the time frame is still longer than the U.S. FDA’s 30-day response window, it is a big step forward compared with the previously estimated average of 195 days, according to Helen Chen, managing director and head of life sciences with L.E.K. Consulting’s China branch.

This also marks a conversion toward common guidelines under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which are widely followed by developed markets.  The change is important given that the agency, just a few weeks ago, proposed a policy change that would allow foreign drugs to be tested in Phase 1 in China.  “The key here is that the system now assumes that the applications can go ahead unless rejected, which is different than the requirement for formal approval before,” Chen said in an interview with FierceBiotech.

However, the question is whether the CFDA fully prepared for such a huge speedup.  The CFDA pilot-tested a 60-day notification for oncology clinical trial applications, and “presumably the results are sufficiently good to give the agency the comfort to open it up to all,” Chen said.

The staff resources are growing as well.  CFDA’s Center for Drug Evaluation (CDE), which is responsible for processing INDs and new drug applications (NDAs), has been on something of a recruiting spree in recent years.  For 2016 and 2017 combined, the Center has planned more than 400 new hires, the majority of whom are drug evaluation specialists.  Compared with the Center for Drug Evaluation and Research (CDER within FDA) in the U.S. and its 5,000-plus reviewers, the Chinese center is quite understaffed with merely 600 drug evaluation specialists, CFDA Commissioner Bi Jingquan said in March during the country’s congressional sessions.  In 2016, the Chinese center completed processing of applications on 961 new clinical trials, 690 novel drugs and 3,655 new generics.

Clinical trial sites—from certification to registration

Once IND evaluations are accelerated, more drug candidates could enter clinical testing more quickly than before.  That means more demand for trial sites, which have been scarce for years.  “The number of clinical trial sites has been a bottleneck in China for both innovative and generic drugs,” Chen said.

In a move that seemingly aims to solve that problem, the CFDA also proposes to change its monitoring of clinical trial sites from a certification system to a registration mechanism.

Currently, if an institution in China wants to conduct clinical trials, it needs to be certified by health authorities.  Only 822 such organizations, mainly public hospitals, have that certificate.  To Chen, that approach has limited the number of trial sites available in China, because the certification process could deter many hospitals that are capable of handling trials — and would very much like to do so.  Under the new proposal, however, new sites would only need to register with the agency.  Regulators themselves would shift focus to inspections rather than up-front evaluations.  “[This] opens up the system to all qualified facilities and thus is a step in the right direction,” Chen said.

The Agency is also encouraging companies and hospitals — both public and private — to establish dedicated trial sites, rather than relying on healthcare treatment facilities at public hospitals.  At the same time, foreign companies and research institutes will also be allowed to conduct Phase 1 trials in China.  The new rules are likely to boost the supply of Phase 1 facilities, Chen said.

The CFDA is also requiring all generic drugs to undergo quality consistency evaluation by the end of 2018, and in another proposal (Chinese) also posted on May 11, it is requiring injectables to go through similar re-evaluations, slated to complete in five to 10 years.  Chen said the new facilities could also support those trials.  “While clinical and technical resources are tight, this new field will undoubtedly attract new investments, which will attract resources,” she said.

However, it also remains to be seen whether the Chinese Agency, on both the national and local levels, has the manpower to ensure the quality of trial sites and the data they yield.  Perhaps the market will help the government out by improving quality up front; after all, bad data or clinical practice, if uncovered by the Agency, would only lead to marketing delays and extra costs — not to mention the Chinese government’s recent crackdown on faking clinical trial data.

Admission of foreign study data

The CFDA also plans to admit foreign clinical data to support registration of drugs and medical devices in China.  “Allowing foreign patient data means that fewer patient samples are needed in China,” said Chen.

Unless otherwise negotiated, CFDA now requires Phase 3 trials of at least 200 patients for chemical drugs and 300 patients for biologics.  Chen’s interpretation is that the new policy would allow data from other countries, generated in international multicenter trials, to be counted toward those CFDA requirements.

For medical devices already approved abroad — unless they’re life-supporting products categorized as Type 3, the Agency’s highest safety level — the CFDA would also allow data supporting foreign approval to be used for the device’s Chinese application.  “The in-China clinical trial requirement has been contentious for the international med techs, who will clearly benefit from this change,” Chen said.

REFERENCE:  Fierce BioTech; 15 MAY 2017; Angus Liu

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