the chinese regulatory licensing regime for pharmaceutical products

442 Michigan Telecommunications and Technology Law Review [Vol. 15:417
NDC. 142 This similarity demonstrates that China has adopted an approach
similar to many other developed countries, such as the United States,
where the importation of drugs is generally subject to the same controls
as the marketing of domestic drugs. 143 For convenience, I refer to this
approach as the “reassessment procedure.”
In contrast, other countries adopt an alternative approach to the reassessment
procedure: developing countries in particular “tend to be
guided by registration decisions made in the country where the drug is
manufactured or in countries where the drug is used.” 144 Under this approach,
the importing countries base their licensing decisions on the
information supplied by the licensing authority in the exporting countries
concerning the safety, efficacy and quality of the drugs, rather than
on clinical trials or other tests carried out in the importing countries. I
refer to this approach as the “recognition procedure.” A typical example
of the recognition procedure is the World Health Organization (WHO)
Certification Scheme on the Quality of Pharmaceutical Products Moving
in International Commerce. 145 Another example is the harmonization and
mutual recognition of drug licensing decision-making among EU member
states. 146
Because China has adopted the reassessment procedure, the analyses
regarding licensing procedures to obtain an NDC can also be generally
regarded as applying to the procedures to obtain an RCID. My analysis
142. RCIDs and NDCs have two main distinctions. First, for imported drugs, the SFDA
is responsible for the initial inspection of the application, supporting documents, data, and
samples; and the China Pharmaceutical Biological Products Testing Institute or an appointed
testing institute initially examines the samples and issues a report. In contrast, for new domestic
drugs, a provincial branch of the SFDA is responsible for the initial inspection of the
application, and its appointed testing institution initially examines the samples and issues a
report. Second, unlike imported drugs, new domestic drugs are subject to a second on-site
inspection and sample test organized by the DCC of the SFDA.
143. See 2001 Drug Administration Law, supra note 5, art. 39; SFDA Commentary,
supra note 5, art. 39.
144. D. C. Jayasuriya, Regulation of Pharmaceuticals in Developing Countries:
Legal Issues and Approaches 55 (WTO 1985).
145. “The WHO certification scheme is an international voluntary agreement, devised to
enable countries with limited drug regulatory capacity to obtain partial assurance from the
exporting countries concerning the safety, quality and efficacy of the products they plan to
import. The voluntary agreement requires that the regulatory authorities of exporting countries
issue Certificates when requested by the importing countries . . . . [The Certificate at least can
attest] whether a specific product is approved for use in the exporting country, or if not, why
not.” World Health Organization, WHO Certification Scheme on the Quality of
Pharmaceutical Products Moving in International Commerce (2000), available at
http://whqlibdoc.who.int/hq/2000/WHO_EDM_QSM_2000.2.pdf. At present, China has not
participated in the WHO certification scheme.
146. See generally John Abraham & Graham Lewis, Europeanization of Medicines
Regulation, in Regulation of the Pharmaceutical Industry 42, 42 (John Abraham &
Helen Lawton Smith eds., 2003).