the chinese regulatory licensing regime for pharmaceutical products

438 Michigan Telecommunications and Technology Law Review [Vol. 15:417
Like the previously-discussed GMP, both GLP and GCP are quality
management systems. GLP provides the organizational process and the
conditions under which laboratory studies (including non-clinical health
and environmental safety studies) are “planned, performed, monitored,
recorded, archived and reported.” 121 “These studies are undertaken to
generate data [about] the hazards and risks to users, consumers and third
parties, including the environment.” 122 GLP helps the licensing authority
verify that the data submitted truly reflect the results obtained during the
studies and can therefore be relied upon when making risk and safety
assessments. 123
The GCP sets ethical and scientific quality standards for “designing,
conducting, recording, and reporting clinical trials that involve the participation
of human subjects.” 124 Compliance with these standards will
ensure that the rights, safety and well-being of trial subjects are secured
and that the clinical trial data are credible. 125 Obviously, these quality
management systems save the SFDA a great deal of informationgathering
and monitoring costs in assessing applicants’ laboratory and
clinical trials. Furthermore, they reduce the possibility of unsafe and ineffective
drugs being approved to enter the market, therefore reducing
larger social costs.
IV. Licensing (Entry) Procedures
This section focuses on licensing procedures for the NDC and RCID
for two reasons. First, the licensing procedures for a manufacturer’s license,
a trader’s license, a clinical test certificate, a production permit
number, or an advertising license are simpler than the procedures for an
NDC or RCID. Second, if the licensing procedures are divided into several
individual steps, almost every step of the licensing procedures used
for a manufacturer’s license, a trader’s license, a clinical test certificate,
a production permit number, or an advertising license has its counterpart
in those procedures for an NDC or RCID.
121. Org. for Econ. Co-operation & Dev. (OECD), OECD Principles of Good
Laboratory Practice 14 (1998), available at http://www.olis.oecd.org/olis/1998doc.nsf/
LinkTo/NT00000C5A/$FILE/01E88455.PDF.
122. Medicines & Healthcare Products Regulatory Agency (MHRA), UK Dep’t
of Health, Good Laboratory Practice (2009) http://www.mhra.gov.uk/Howweregulate/
Medicines/Inspectionandstandards/GoodLaboratoryPractice/CON009680.
123. Id.
124. International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH), Guidance for Industry:
E6 Good Clinical Practice: Consolidated Guidance 1 (1996), available at http://
www.fda.gov/cder/guidance/959fnl.pdf.
125. Id.