On October 31, 2013, The China Food and Drug Administration
("CFDA") promulgated a regulation titled Guiding
Principles for the Quality Management of Clinical Studies on
Vaccines ("Vaccine GCP"), with immediate effect. The
Vaccine GCP applies to registration studies and stipulates the
requirements for study initiation, implementation, and quality
management in detail. It also sets forth the responsibilities of
sponsors, clinical research organizations, site/investigators, and
While vaccine studies normally involve healthy subjects and are
conducted at vaccination stations rather than hospitals, the
Vaccine GCP introduces a more stringent risk control mechanism
compared to the existing Drug GCP.
qualification: In addition to accreditation by the CFDA,
prior to formal engagement, the study sponsor shall conduct an
on-site assessment of potential study sites on their study
administration and quality management systems including, personnel,
capabilities of handling adverse events, storage and transportation
facilities for study vaccines, and implementation of various
policies and SOPs governing clinical studies.
reporting: The sponsor shall define an SOP for safety
reporting jointly with the investigator(s), train all study
personnel on the SOP, and assign dedicated persons to manage the
reporting process. The sponsor shall also form a data and safety
monitoring board as well as an end-point evaluation board to
monitor and evaluate any risk signal in a timely manner. The
sponsor shall report suspected and unexpected serious adverse
events to the Center for Drug Evaluation within seven calendar days
upon its first awareness and report any follow-up information
within the subsequent eight calendar days. Sites/investigators
shall promptly inform ethics committees of the latest safety
information provided by the sponsor.
The ethics committee shall consist of representatives from the
medical fields, non-medical fields, legal profession and
independent third parties. The ethics committee members shall
include representatives not affiliated with the site and these
outside representatives shall account for at least 40% of the
ethics committee members. The composition of the ethics committee
and contact information of each ethics committee member shall be
publically disclosed and registered with the CFDA.
transportation of vaccines: The sponsor shall clearly define
requirements for cold-chain management throughout the course of the
study and disposal process for study vaccines in the event of
cold-chain disruption. The lead site shall assist study sites in
developing systems for vaccine administration and ensure that the
receipt, retention, dispensing, recycling, and return/disposal of
study vaccines comply with applicable laws.
Vaccines manufacturers shall incorporate the requirements under
the Vaccine GCP in its study agreements and study-related SOPs in a
timely manner to avoid the CFDA's order for study suspension or
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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