The Chinese State Food and Drug Administration
("SFDA") announced a plan for regulatory reform
("Reform Plan") and is soliciting public comments through
January 15, 2013. The Reform Plan sets forth the following key
1. To accelerate technical reviews and regulatory approvals for
SFDA will reward drug R&D which delivers better therapeutic
effects on critical diseases and leads to indigenous intellectual
property by accelerated technical reviews and regulatory approvals
for the resulting innovative drugs.
Innovative drugs whose R&D is sponsored by Chinese
government will be given high priority in technical reviews.
Pre-clinical studies of innovative drugs should be risk-based
and their technical evaluation should aim for better control of
quality risks. SFDA may outsource the task of technical review for
pre-clinical studies to designated third parties.
SFDA will explore the feasibility of performing technical
reviews for innovative drugs along with the ethics review and
consider allowing transfer of clinical trial authorizations.
2. To accelerate technical reviews and regulatory approvals for
high priority generics
SFDA will establish an evaluation mechanism for marketed
generic drugs. Generic drugs which fail to demonstrate sufficient
clinical values will be discouraged from further development and
manufacturing. The agency plans to involve relevant authorities,
industry experts, and nongovernment organizations in the
development of the evaluation mechanism.
Generics which have a shortage in supply, insufficient
competition, limited patient access and affordability, an
indication for pediatric, rare or special diseases and have been
evaluated as urgently required for clinical use will be given high
priority in technical reviews and regulatory approvals.
The review process for high priority generics will be
streamlined. The high priority generics will be separated from
other generics for technical reviews, on-site inspections of
manufacturing facilities and product testing. A prior recordal
registration for BA/BE studies may be introduced in place of a
clinical study authorization from SFDA. Failure to complete the
registration record will prohibit the high priority generics from
The quality consistency evaluation for generics will be a major
policy initiative in the next couple of years and will lead to the
formation of a Chinese Orange Book.
3. To improve quality control for clinical studies
SFDA will impose more stringent requirements on the
organizational structure, personnel and operational procedure of
ethics committees to ensure effective and independent ethics
SFDA will establish an information disclosure mechanism to
enhance transparency of clinical studies and raise public awareness
of the notion of, and need for, clinical studies.
SFDA will enhance oversight on the implementation of clinical
studies and require sponsors, study sites and ethics committees to
strictly comply with statutory requirements. Noncompliance will
lead to suspension of the relevant studies. Falsification of study
data will disqualify the study sites and prohibit the study drug
from market authorization.
4. To encourage development and manufacturing of pediatric
SFDA will work with other relevant government agencies to
define incentives for pediatric drugs in relation to tendering,
pricing and reimbursement. Generic drugs with specification and
dosage form suitable for pediatric diseases will be given high
priority in technical reviews and regulatory approval. Pediatric
drugs may be subject to special monitoring periods and enjoy
To implement the above strategic priorities successfully, SFDA
plans to revise the Drug Registration Rules and align the Rules
with the international norm. To improve operational efficiency and
better manage workload at SFDA, the agency has piloted the
delegation of review and approval authorities in relation to
contract manufacturing and technology transfer to Guangdong FDA in
2012 and may expand the delegation of authority or further roll out
the pilot. Chinese drug manufacturers are encouraged to develop and
manufacture drugs to conform to international standards and their
data derived from overseas clinical studies will be admitted for
domestic technical reviews and regulatory approvals. SFDA will also
enhance transparency of the regulatory approval process by
establishing an online communication platform for applicants with
Center of Drug Evaluation ("CDE") and introducing formal
meeting minutes to document consensus between applicants and CDE
The requirement to provide home care packages on a consumer directed care basis (CDC) commenced on 1 July 2015.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).