Effective October 16, China’s National Health and Family Planning Commission recently released Administrative Measures for the Clinical Study Projects of Medical Institutions with the China Food and Drug Administration and the Administration of Traditional Chinese Medicine. The measures are meant to supplement the current research regulations, and should be read in conjunction with the general anti-corruption disciplinary rules in the “Nine Prohibitions” issued in late 2013, according to the law firm Ropes & Gray.
China currently regulates clinical trials via a compulsory ethics committee review, as well as through Good Clinical Practices governing drugs and devices, and a certification system to permit eligible hospitals to undertake studies.
John Moller, COO of Novotech, an Australian CRO with operations in China, told this publication that China is “clearly attractive” to run clinical trials in because of the size of the market and the “scale of hospitals is also really impressive with the ability to draw a huge number of patients from 4,000 bed facilities.
“If pharma companies have the potential to market in China, they should consider running trials there to reduce the eventual time to market,” Moller said.
On the negative side, however, are the costs, which “are not that low in China anymore,” Moller added, noting that of the nine countries in Asia where Novotech has an office, China would rank as “fourth most-costly.”
The regulatory timeframe “is the largest issue that we face with registration taking 10-12 months if there are no major deficiencies and over 2 years for biologics,” he added. “Dossier preparation will take 2-3 months on top of this driven by translation requirements. The main issue from the SFDA’s perspective seems to be resourcing, and I’m sure they face the challenge that their expert regulatory staff will also have plenty of opportunities in the private sector.
In terms of reducing timeframes, Moller suggests the country should increase the adoption of electronic submission, standardise forms, processes and training to ensure a consistent approach to guideline interpretation.
“Setting up in China was certainly not easy, and the hurdles in terms of business capitalisation, the need to have a lease in place before registering, and business plan requirements were higher than in our other markets,” he added.
The new requirements for hospitals include the need to establish internal rules and standards of procedures for administering clinical studies, to centralize the financing of clinical studies at the hospital level, and to maintain constant supervision of trials.
In addition to an ethics committee, hospitals are being required to form a Clinical Study Administration Committee to make supervisory decisions over study-related matters.
Funding of clinical studies also must be channeled to a dedicated hospital account and not to a particular clinical department or an individual physician, according to the new rules. The officials make clear that sponsors can’t cover a participating subject’s expenses, such as the cost of study drugs or a physical exam, and then charge a hospital for those fees.
The hospital also must approve all clinical study projects before implementation. The applying physician must submit relevant information to the hospital for approval, such as the CV and qualifications of the investigators, summary of the scientific basis of the research (e.g., pre-clinical laboratory data and animal trial data), study protocol, quality management protocol, risk evaluation and risk management proposal, form of informed consent letter for patients, any covenant on intellectual rights, and the financial sources sponsoring the study.
After the hospital approves the project, it must within 30 days file the clinical study project for record with the local counterpart of NHFPC that has granted its medical practice license, in addition to a filing with the local FDA as per current rules.
“There is also a lot of scrutiny on corrupt practices in China, with a recent focus on the health sector,” Moller continued. “This gives us increasing confidence in the increasing quality in the clinical trial sector. For example, there is now much greater local acceptance of the need for clearly documented service contracts, invoicing, and payment tracking for things such as site and investigator payments.”