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Processing Authority: Drug Registration Department of Shanghai Drugs
Administration Bureau
Processing Procedures:
1. Clinical application of preparation of medial
care institutions
(1) The medical care institution should prepare a set of
applying documents according to the Document Requirement on Preparation
Application of Medical Care Institution (Appendix II), and fill in corresponding
contents of Preparation Application Form of Medical Care Institution, and submit
to the Drug Registration Department of Shanghai Drugs Administration Bureau
along with the application reports.
(2) Drug Registration Department of
Shanghai Drugs Administration bureau will carry through modal examination on the
application documents and accept those meet the requirements and issue Notice of
Payment.
(3) Shanghai Drugs Administration Bureau will take an appraising
method combining internal assessing and experts assessing on the preparation
documents of medical care institution, and issue Approval Certificate on
Clinical Research of Preparation of Medical Care Institution to the qualified
applicants.
(4) After acquiring approval on clinical research, the medical
care institution should submit related documents such as the clinical research
plan and approval document from Ethics Advisory Commission to Shanghai Drugs
Administration Bureau for records and get registration and record number before
starting the clinical researches.
2. Preparation confecting application of
medical care institutions:
After finishing the clinical research of the
preparation, the medical care institution shall summarize the safety and
validity of the clinical application, and continue to fill in corresponding
contents of the Preparation Application Form of Medical Care Institution. The
institution should also prepare a set of applying documents according to the
Document Requirement on Preparation Application of Medical Care Institution
(Appendix II), and submit to the Drug Registration Department of Shanghai Drugs
Administration Bureau along with the application reports.
If the institution
dose not finish the clinical research work and applies for the preparation
confecting in time within a prescribed time period (1 to 2 years) without
special reasons, nor applies for a time postpone, the original approval document
for the clinical research will invalidate automatically.
3. If need
supplement documents, the applicant should supplement related documents in
required time period according to the written notice. The overdue applicant will
be considered as giving up the application. The time for supplementing documents
will not be calculated in the approving work of the authorities.
4. For the
unqualified applicants, Shanghai Drugs Administration Bureau will issue to the
applicants written notice of not approving the application or returning the
application.
5. If the medical care institution need any modification on the
preparation recipe, confecting techniques, and preparation quality standards,
the institution need submit related documents to Shanghai Drugs Administration
Bureau for re-assessing according to the requirements of supplementary
application (refer to Appendix II) and make modifications only after being
approved.
6. The preparation of medical care institution needs registration
every 3 years. The authority will re-assess the preparations according to
performances of safety, validity, quality and stability, in order to wash out
the preparations that are no more needed in clinical using, no assured curative
effects, big adverse drug reactions, or unstable quality.
Processing Address: Processing Address: Room 1106, No. 189 Pu-An Road
Processing Basis:
Drug Administration Law of People's Republic of China
(Order No. 45 of the President of the People's Republic of China)
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)
Contact Tel: 63855666-142
Processing Time: Tuesday and Thursday 9：00a.m.-11：00a.m. and 2：00p.m.
-5：00p.m.
Time Limit for Processing:
The time limit for processing is calculated
from the notice of acceptance issuing date to the appraising fee receiving date.
The time limit for the new application will not over 60 working days (including
40 working days limit for the technical assessing of Shanghai Drugs Inspecting
Institution); the time limit for the supplementary application will not over 60
working days (including 30 working days limit for the technical assessing of
Shanghai Drugs Inspecting Institution).
Qualification of the applicants:
Fix recipe preparations confecting by
medical care institutions that are needed by clinical application, yet with no
supplying in the market. The preparations confecting by medical care institution
only include Chinese traditional medicine preparations and chemical medicine
preparations (western medicine preparations). The scopes do not include
bio-preparations made by blood or viscera tissues of people or animals, nor
preparations compound the Chinese traditional medicine and western medicine. The
institution should not confect preparations including anesthetic, detoxification
medicine, and first class spirit drugs on its own way. If the institution has
necessity to confect such drugs in special conditions, it has to report to
Shanghai Drugs Administration Bureau, and confect the preparation after being
approved.
Medical care institution that equipped with Medical Care
Institution Operation License and Preparation Permission of Medical Care
Institution which suits the confecting scope
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