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Processing Authority: Drug Registration Department of
Shanghai Drugs Administration Bureau
Processing Procedures:
1. The applicant shall finish
the trial producing work, fill in the Application Form for Drug Registration,
and hand in related technical documents and samples to Shanghai Drugs
Administration Bureau. (the Application Form for Drug Registration can be
downloaded from the website of State Drugs Administration Bureau
www.sda.gov.cn
)
2. Shanghai Drugs
Administration Bureau will carry through a modal examination on relevant
documents submitted by the applicant, and issue notice of acceptance to the
qualified.
3. The authority should organize spot inspections on the producing
condition, choose 3 samples with continuous approval number randomly, and ask
the drug inspecting institution to make tests.
4. The authority should submit
auditing opinion and relevant application documents to State Drugs
Administration Bureau within the prescribed time limit and notify the
applicant.
5. The drug inspecting institution should test on the samples, and
submit the testing reports to State Drugs Administration Bureau within the
prescribed time limit, and pass to Shanghai Drugs Administration Bureau and the
applicant as well.
Charging Standard & Basis:
The appraising fee
will be RMB 1500 for each species according to Notice on Adjusting the Charging
Standards of Drug Assessing and Appraising (Ji Jia GE (1995) no. 340),
promulgated by State Planning Commission and Ministry of Finance. (Note: one
material medicine or one preparation is considered as one specie; 20% more of
appraising fee for one more specification.)
Processing Address: Processing Address: Room 1106, No.
189 Pu-An Road
Processing Basis:
1. Drug Administration Law of
People's Republic of China (Order No. 45 of the President of the People's
Republic of China)
2. Rules of the Implementation of Drug Administration Law
of People's Republic of China (Order No. 360 of the State Council of the
People's Republic of China)
3. Administration Regulation on Drugs
Registration (Interim) (Order No. 35 of State Drugs Administration Bureau)
4.
Notice on Adjusting the Charging Standards of Drug Assessing and Appraising (Ji
Jia GE (1995) no. 340 of State Planning Commission and Ministry of
Finance)
Contact Tel: 63855666-142
Processing Time: Tuesday and Thursday 9：00a.m.-11：30a.m.
and 1：30p.m.-5：30p.m.
Time Limit for Processing:
1. Drug Registration
Department make decisions on whether accepting the application or not within 2
days after receiving the application documents;
2. The authority organize
spot inspecting, sample taking, and ask drug inspecting institutions to test
within 5 days after issuing the acceptance notice;
3. Drug Registration
Department report the auditing opinion, inspecting report, and documents
submitted by the applicant to State Drugs Administration Bureau, and notify the
auditing opinion to the applicant;
4. The drug inspecting institution should
finish the sample testing within 30 working days after receiving the testing
notice and samples. For special drugs and bacterin products, the testing work
could be finished within 60 working days. The counterchecking of quality
standards should be finished within 60 working days, and for special drugs and
bacterin products, the work could be finished within 90 working days;
5. The
auditing procedure and time limit of State Drugs Administration Bureau should
follow the regulation of Administration Regulation on Drugs Registration
(Interim) promulgated by State Drugs Administration Bureau.
Qualified Application Subject:
The application of
existing national standard drugs means the registration application of drugs
that have formal standards promulgated by State Drugs Administration
Bureau.
Qualification of the applicants:
1. The applicant
should be drug manufacturers with Drug Producing License and cognizance
certificate of Drug Production Quality Administration Criterion. The product it
applies should be consistent with the business scope regulated by the Drug
Producing License and Drug Production Quality Administration Criterion;
2.
The new-established drug manufacture, extended workshop (or product line) of
drug manufacturers, or new-increased production scope, which have not acquired
the cognizance certificate of Drug Production Quality Administration Criterion,
should acquire the cognizance certificate of Drug Production Quality
Administration Criterion within the time limit regulated by the 6th Article of
Rules of the Implementation of Drug Administration Law. For the overdue
applicant, his drug approval number will be abolished automatically, and
cancelled by State Drugs Administration Bureau.
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