China's health authority, the National Health and Family
Planning Commission ("NHFPC"), recently released the
Administrative Measures for the Clinical Study Projects of
Medical Institutions ("the Measures") jointly with
China Food and Drug Administration ("CFDA") and the
Administration of Traditional Chinese Medicine, effective as of
October 16, 2014. According to the NHFPC, the Measures, as a
specific code of conduct for research behaviors of hospitals and
physicians, should be read in conjunction with the general
anti-corruption disciplinary rules in the "Nine
Prohibitions" issued in late 2013.
In the Measures, the authorities mandated several requirements
for hospitals conducting studies as clinical sites. By way of
background, China regulates clinical studies primarily by a
compulsory ethics committee ("EC") review regime, a
clinical trial authorization system for all drugs and certain high
risk devices, the Good Clinical Practices ("GCP")
governing drugs and devices respectively, and, last but not least,
a certification system to permit eligible hospitals to undertake
studies. The new Measures supplement the current regulatory regime
with the following key requirements for hospitals:
To establish internal rules
and organizations administering clinical studies
Hospitals must establish internal rules and SOPs for administering
clinical studies. In addition to an EC, hospitals must also form a
Clinical Study Administration Committee ("CSAC"). The
CSAC, composed of the hospital's relevant leaders, division
chiefs and clinical study experts, will make supervisory decisions
over study-related matters of the hospital. A subordinate
implementing body, Clinical Study Administration Division
("CSAD"), needs to be created to handle daily
administration of study projects.
To centralize financial
management of clinical study projects at the hospital
Funding of clinical studies must be channeled to a dedicated
hospital account and not to a particular clinical department or an
individual physician involved in the project. The use and
distribution of the clinical study funds must follow the
hospital's financial rules and the budget plan for the specific
study project. If a sponsor has already covered any of the
participating subject's expenses, such as the cost of study
drugs or a physical exam, the hospital cannot charge the patient
subject for such fees.
To maintain a project-based
approval system and supervision throughout the study
The hospital 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. The hospital EC
will carry out the first round review of the project. If the
application passes the first round, the CSAD will submit the
application for approval by the CSAC.
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
The CSAC and CSAD must continuously oversee the study throughout
its entire course. They must periodically evaluate the project with
regard to the research ethics, safety, effectiveness, and financial
compliance and commercial bribery risks. The hospital must report
any irregularities found during such evaluation to the local health
authority and should adjust, suspend or terminate the study where
necessary, subject to CSAC approval.
Life science companies are recommended to review their internal
policies governing clinical studies to reflect the latest
regulatory requirements. They also need to be mindful for potential
delay in the conduct of clinical studies due to the additional
layers of approvals within hospitals.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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