Processing Procedures:
1. Any and all of
applicants shall, subject to the category of the newly developed drug and the
applicable technical requirements, complete pre-production, fill in the
Application Form for Drug Registration which can be downloaded from www.sda.gov.cn, and present the required
materials for such application and the drug sample to Shanghai Food and Drug
Administration.
2. Shanghai Food and Drug Administration will, upon passing
the initial form review of the materials necessary for application, issue the
Acknowledgement Form of Receipt of Materials for Registration of New Drug;
3.
Shanghai Food and Drug Administration shall, within the required time frame upon
receipt of the materials for application, organize and complete form review,
inspection of source materials, filed survey and sampling, notify the Shanghai
Institute of Drug Control to conduct sample inspection and review of quality
standard, if necessary, and issue the corresponding opinion of review and report
of survey.
4. Shanghai Institute of Drug Control shall, upon receipt of the
notice of registration inspection, conduct the sample inspection and review of
quality standard, present the report of inspection and opinion of review of
quality standard to State Food and Drug Administration within the required time
fame, and copy them to both Shanghai Food and Drug Administration and the very
applicant.
5. Shanghai Food and Drug Administration shall, in case of passing
review, report the materials necessary for application with the opinion of
review to State Food and Drug Administration for final review and approval, and
inform the very applicant of such reporting.
Charging Standard & Basis:
Subject to the Notice on Adjustment of Charging Scale for Drug Review and
Inspection under Ji Jia Ge (1995) No. 340 jointly issued by State Plan
Commission and Ministry of Finance, the review charges for application for
clinic research of new drugs or for certificate/production of new drugs shall be
imposed. Follows are the detailed charging scale:
Category of New Drugs
Clinic Research (in RMB) Certificate/Production of New Drug
Class I 2,500
4,300
Class II 2,500 4,300
Class III 2,500 3,500
Class IV 2,000
3,500
Class V 2,000 3,500
Charges for review of new drugs shall be imposed
under the standard of taking one bulk drug or preparation as one type. In case
of adding one specification, another 20% of the review charge shall be collected
as per the corresponding category.
Processing Address: Room 1106, No. 189,
Pu'an Road, Shanghai
Processing Basis: 1. Pharmaceutical Administration Law
of the People's Republic of China under No. 45 Presidential Order of the
People's Republic of China;
2. Regulations of Implementation of
Pharmaceutical Administration Law of the People's Republic of China under No.
360 Order of State Council;
3. Measures for Administration of Drug
Registration (for trial implementation) under No. 35 Order of State Food and
Drug Administration; and
4. Notice on Adjustment of Charging Scale for drug
Review and Inspection under Ji Jia Ge (1995) No. 340 jointly issued by State
Plan Commission and Ministry of Finance.
Contact Tel:
63855666-142
Processing Time: Tuesdays or Thursdays: 9:00~11:30 and
13:30~17:30
Time Limit for Processing:
1. Shanghai Food and Drug
Administration shall, within 5 working days upon receipt of the materials
required for application in general case, arrange and carry out the field survey
of development and/or production site and inspection of source materials;
2.
Shanghai Food and Drug Administration shall, within 30 working days upon issue
of the Acknowledgement Form of Receipt of Materials for Registration of New Drug
in general case, complete the form review, review of source materials, field
survey and sampling, notify the Shanghai Institute of Drug Control to conduct
sample inspection and review of quality standard, if necessary, and issue the
corresponding opinion of review and report of survey;
3. Shanghai Institute
of Drug Control shall complete the sample inspection within 30 working days upon
receipt of the notice of registration inspection and the sample drug, or 60
working days in case of the special drugs and vaccine category products, and
complete the review of the quality standard within 60 working days, or 90
working days in case of the special drugs and vaccine category produces, if
necessary; and
4. Procedures and time frame for review by State Food and Drug
Administration shall be subject to the Measures for Administration of Drug
Registration (for trial implementation).
Qualified Application Subject:
Application by the production/research entity within the territory of Shanghai
Municipality for registration of any traditional Chinese medicine that is never
sold in the domestic market, new natural drug, new chemical drug, and new
biological product, including application for clinic study of the new drug or
certificate/production and sales in market of the new drug.
1. Any and all of
corporate organizations legitimately registered in the Chinese territory can act
as the drug registration applicants (hereinafter referred to as the applicants)
to apply for clinic study or certificate of the very new drug.
2. Any and all
of drug production enterprises holding the License of Drug Production and the
certificate of the Drug Good Manufacture Practice (GMP) certification are
entitled to apply for production of the new drug within the scope of the checked
category of preparation;
3. Any newly incorporated drug production
enterprise, the newly established workshop of the drug production enterprise, or
newly added production preparation category without the certificate of Drug GMP
certification, shall obtain such certification within the due course of time
provided in Article VI under the Regulations of Implementation of Pharmaceutical
Administration Law of the People's Republic of China, otherwise the registered
number of approval for the very drug shall be annulled automatically and
cancelled by State Food and Drug Administration. |
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