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Processing Authority: Drug Registration Office under
Shanghai Food and Drug Administration
Processing Procedures:
1. Any and
all of applicants shall fill in the Application Form for Supplementation for
Drug and present the required materials and specifications to Shanghai Food and
Drug Administration, and, in case of involving alteration of title of the drug,
provide the valid supporting documents wherefor (note: the Application Form for
Supplementation for Drug can be downloaded directly from
www.sda.gov.cn
);
2. The very applicant shall
present the required materials to Shanghai Food and Drug Administration which
will, upon meeting requirements for form review, issue the notice of acceptance
of application for supplementation for drug;
3. Shanghai Food and Drug
Administration will organize and conduct field survey of production
circumstances and conditions subject to the applicable provisions, sample from
the straight 3 batches, inform the Shanghai Institute of Drug Control to conduct
due inspection, and bring out the opinion of review in due course of time.
4.
Shanghai Institute of Drug Control will, upon receipt of the notice of
inspection of registration, inspect the samples and present the report of
inspection to Review Center Shanghai Food and Drug Administration in due course
of time.
5. Shanghai Food and Drug Administration will, in case of adding
indications or effective functions, modification of drug standard, alteration of
auxiliary materials, or other supplementary application, bring out the opinion
of review, report to State Food and Drug Administration for final review and
approval, and inform the very applicant.
Shanghai Food and Drug
Administration will, in case of alteration of drug packaging specification or
business name the very enterprise, modification of drug standard and instruction
subject to requirements by State Food and Drug Administration, or other
supplementary application, conduct final review, report to State Food and Drug
Administration for record filing, and inform the very applicant.
Processing Address: No. 18399, Huashan 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; and
3. Measures for Administration of Materials/Containers for
Drug Packaging (for interim implementation) under No. 21 Order of State Food and
Drug Administration.
Contact Tel: 62949719
Processing Time: Tuesdays or
Thursdays: 9:00~11:30 and 13:30~17:30
Time Limit for Processing:
1.
Review Center shall, within 2 days upon receipt of the materials required for
application, make the decision of acceptance or not;
2. Review Center shall,
upon issue of the notice of acceptance, arrange within 5 days and organize
within 15 days inspection, sampling, and inform the test institution of quality
of drug packaging material to conduct test;
3. The competent test institution
of quality of drug packaging material shall, within 30 working days upon receipt
of the notice of inspection of registration, complete inspection of the samples,
or within 60 working days in case of the review of quality standard, if
necessary;
4. Review Center shall, within 7 days upon receipt of result from
the test institution of quality of drug packaging material, summarize the
opinions of review and report of inspection, and report them with materials for
application presented by the very applicant to Shanghai Food and Drug
Administration which shall, upon review and approval by the leader whereof,
report to State Food and Drug Administration for final review and issue of the
certificate of registration of drug packaging material, or directly issue the
certificate of registration of drug packaging material
Qualified Application
Subject: Products of drug packaging materials can be classified into Class I and
Class II (see attached Annex 1 for classified catalogue of drug packaging
materials).
Class I drug packaging materials refer to those
materials/containers that make direct contact with drugs and are used
directly.
Class II drug packaging materials refer to those
materials/containers that make direct contact with drugs, but can be washed
easily, and can be sterilized after washing up in the practical use.
1. Any
and all of applicants shall hold the business licenses of incorporated
enterprises.
2. Any and all of applicants shall possess the reasonable
technique, equipments, requirements for cleanness, instruments for test and
inspection, personnel, management system, and other necessary conditions
assuring quality to produce the very product.
Charging Standard & Basis:
Subject to the Notice on Adjustment of Charging Scale for Drug Review and
Inspection (Ji Jia Ge [1995] No. 340) jointly issued by State Plan Commission
and Ministry of Finance, the review charges for application for alteration of
drug specification shall be RMB 1,500 (Note: One source material or one
preparation shall be taken as one type in collection. In case of adding one more
specification, another 20% of the review charge shall be imposed); and the
clinic and production review charges for application for adding indications or
effective functions shall be RMB 2,000 and 3,500 respectively.
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 Registration of Drugs under No. 35 Order of State Food and Drug
Administration; and
4. Notice on Adjustment of Charging Scale for Drug Review
and Inspection (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. Drug Registration Office shall, within 2 days upon receipt of
the materials required for application, make the decision of acceptance or
not;
2. Drug Registration Office shall, upon issue of the notice of
acceptance, arrange field inspection and sampling within 5 days, and inform
Shanghai Institute of Drug Control to conduct test and inspection;
3. Drug
Registration Office shall, within 30 days, bring out the opinion of review and
report of inspection (completion within 10 days in case of standard
registration), and, upon review and approval by the leader whereof, present the
report of drug inspection with materials for application by the very applicant
to State Food and Drug Administration, and inform the very applicant;
4.
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.
5. 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) issued
whereby.
Qualified Application Subject:
Scope of Application:
In case
of any alteration of the supporting document of approval of the very drug as
well as the attached drug standard, drug instruction, contents specified in the
label, and change of production technique that may affect the drug quality, the
very applicant shall make the application for supplementation.
Qualifications/Prerequisites for Applicants
Any and
all of applicants applying for supplementation shall be the holders of the
supporting documents of approval of the very drugs or the applicants of
registration of the very drugs.
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