the chinese regulatory licensing regime for pharmaceutical products

440 Michigan Telecommunications and Technology Law Review [Vol. 15:417
Fifth, the applicant must, within six months after receiving the invitation,
apply to the Drug Certification Center (DCC) of the SFDA for an
on-site inspection. 135 The DCC shall, within 30 days after receiving the
application, conduct the on-site inspection, verify the applicability of the
manufacturing processes and take samples, all at the same time. 136 It shall
provide a report to the CDE within ten days after the inspection. An appointed
testing institute will test the new samples and report its
conclusion to the CDE. 137
Sixth, the CDE shall make suggestions based upon the technical assessment,
on-site inspection report, and sample testing. Acting on these
suggestions, the SFDA will decide whether to grant the NDC to the applicant
either within 20 days or, alternatively, within 30 days if the chief
of the SFDA agrees to this extension. 138
Seventh, once the SFDA decides to grant the NDC, the agency shall
issue and deliver it to the applicant within 10 days. If the SFDA refuses
to grant the NDC, the applicant can apply for a review within 60 days of
receipt of the SFDA’s decision. 139 The SFDA shall complete the review
and make a decision within 50 days of receipt of the application. 140
Chart 2 describes the licensing procedures in detail: 141
135. Id. art. 61.
136. Id. art. 62.
137. Id.
138. Id. art. 152.
139. Id. art. 156.
140. Id. art. 157.
141. Id. arts. 45, 56–59, 148–151, 153.