The Center for Drug Evaluation ("CDE") in China
recently published the draft Guidelines for the Administration of
Post-Market Studies on Chemical Drugs and Therapeutic Biologics
("Draft Guidelines") for public comments through November
21, 2013. The Draft Guidelines mainly apply to post-market studies
required by the China Food and Drug Administration
("CFDA") as a pre-requisite for the new drug
authorization ("NDA") in China. Post-market studies of
OTC drugs or generic drugs are not subject to the Draft Guidelines.
The Draft Guidelines also recognize post-market studies initiated
at the discretion of the marketing authorization holder or any
third party and may apply mutatis mutandis to these discretionary
The format of post-market studies can include clinical studies,
surveys (e.g., observational/ epidemiological studies), animal
studies or lab tests, each of which is further elaborated in the
draft Technical Guidance for Post-market Studies on Chemical Drugs
and Therapeutic Biologics. The relevant department at the CFDA
(i.e., CDE or the Center for Drug Re-evaluation, CDR) will propose
a list of possible post-market studies expected from the marketing
authorization holder before issuing the NDA, as well as identify
the mandatory/discretionary studies. The marketing authorization
holder is encouraged to discuss the design and conduct of these
post-market studies with the relevant department at the CFDA and
propose an implementation schedule. A final proposal for the study
design and conduct shall be submitted to the relevant department at
the CFDA for review and confirmation by the marketing authorization
holder upon receipt of a formal notice on post-market studies.
Upon receipt of written confirmation by the relevant department
at the CFDA on the soundness of the study protocol and completion
of registration in the online clinical study registry, the
marketing authorization holder is allowed to initiate the
post-market studies. Any material change in the study protocol will
need to be reviewed and confirmed by the relevant department at the
CFDA. The marketing authorization holder will also need to submit
regular progress reports to the relevant department at the CFDA
during the course of the post-market studies. The results of
post-market studies will be evaluated concurrently by the marketing
authorization holder and the relevant department at the CFDA to
ascertain any impact on the marketing authorization.
R&D-based biopharmaceutical companies are advised to
carefully review the Draft Guidelines and modify their internal
policies and processes governing the initiation and implementation
of post-market studies accordingly.
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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