Processing Authority: Safety Control Office under
Shanghai Food and Drug Administration
Processing Procedures:
(I)
Application
1 In case both entrusting and entrusted parties are the drug
production enterprises in Shanghai:
The very entrusting party shall present
any and all of following materials to Shanghai Food and Drug
Administration:
(1) the report of application;
(2) the Application Form of
Drug Production on Commission in triplicate;
(3) the xerox copies of the
Licenses of Drug Production and Business Licenses of Incorporated Enterprise of
both entrusting party and entrusted party;
(4) the xerox copy of the
Certificate of Drug GMP of the trusted party;
(5) the assessment of
conditions assuring production and quality of the entrusted party by the
entrusting party;
(6) the xerox copy of the supporting document of approval
of the drug production of the entrusting party attached with the quality
standard, production technique, packaging, label, and the single pattern of the
specification;
(7) the proposed packaging, label, pattern of specification,
and colour code of the drug produced on commission;
(8) the contract for
production on commission; and
(9) the report of inspection for the straight
three batches of products by Shanghai Institute for Drug Control.
2 In case
the entrusting party is the drug production enterprise in Shanghai, and the
entrusted party is the drug production enterprise in other province, autonomous
region or municipality of China:
The very entrusting party shall present any
and all of following materials to Shanghai Food and Drug Administration:
(1)
the report of application in writing;
(2) the Application Form of Drug
Production on Commission in triplicate;
(3) the xerox copies of the Licenses
of Drug Production and Business Licenses of Incorporated Enterprise of both
entrusting party and entrusted party;
(4) the xerox copy of the Certificate
of Drug GMP of the trusted party;
(5) the assessment of conditions assuring
production and quality of the entrusted party by the entrusting party;
(6)
the xerox copy of the supporting document of approval of the drug production of
the entrusting party attached with the quality standard, production technique,
packaging, label, and the single pattern of the specification;
(7) the
proposed packaging, label, pattern of specification, and colour code of the drug
produced on commission;
(8) the contract for production on commission;
and
(9) the report of inspection for the straight three batches of products
by the institute for drug control at the provincial level.
3 In case the
entrusting party is the drug production enterprise in other province, autonomous
region or municipality of China, and the entrusted party is the drug production
enterprise in Shanghai:
Any and all of following materials shall be presented
to Shanghai Food and Drug Administration by the food and drug administration of
the other province, autonomous region or municipality of China which governs the
entrusting party:
(1) the report of application in writing by the entrusting
party to the competent local food and drug administration which governs the
place where the entrusting party is located;
(2) the Application Form of Drug
Production on Commission in triplicate;
(3) the xerox copies of the Licenses
of Drug Production and Business Licenses of Incorporated Enterprise of both
entrusting party and entrusted party;
(4) the xerox copy of the Certificate
of Drug GMP of the trusted party;
(5) the assessment of conditions assuring
production and quality of the entrusted party by the entrusting party;
(6)
the xerox copy of the supporting document of approval of the drug production of
the entrusting party attached with the quality standard, production technique,
packaging, label, and the single pattern of the specification;
(7) the
proposed packaging, label, pattern of specification, and colour code of the drug
produced on commission;
(8) the contract for production on commission;
and
(9) the report of inspection for the straight three batches of products
by Shanghai Institute for Drug Control.
(II) Review
1 In case both
entrusting and entrusted parties are the drug production enterprises in
Shanghai:
Shanghai Food and Drug Administration shall, within 30 working days
upon receipt of materials necessary for application for drug production on
commission presented by the very enterprise, complete the due review and
assessment, bring out the opinion of the first review, and report to State Food
and Drug Administration for final review and approval.
2 In case the
entrusting party is the drug production enterprise in Shanghai, and the
entrusted party is the drug production enterprise in other province, autonomous
region or municipality of China:
Shanghai Food and Drug Administration shall,
within 10 working days upon receipt of materials necessary for application for
drug production on commission presented by the very enterprise, bring out the
opinion of the first review, and forward them to the competent food and drug
administration at the provincial/autonomous region's/municipal level which
governs the place where the entrusted party is located.
3 In case the
entrusting party is the drug production enterprise in other province, autonomous
region or municipality of China, and the entrusted party is the drug production
enterprise in Shanghai:
Shanghai Food and Drug Administration shall, within
20 working days upon receipt of materials necessary for application for drug
production on commission forwarded by the competent food and drug administration
at the provincial/autonomous region's/municipal level which governs the place
where the entrusting party is located, complete the due review and assessment,
bring out the opinion of the first review, and report to State Food and Drug
Administration for final review and approval.
Processing Address: Room 1102,
No. 189, Pu'an Road, Shanghai
Processing Basis: 1. Pharmaceutical
Administration Law of the People's Republic of China ;
2. Regulations of
Implementation of Pharmaceutical Administration Law of the People's Republic of
China; and
3. Measures for Supervision and Administration of Drug Production
(for trial implementation)
Contact Tel: 021-63879380
Processing Time:
Mondays through Fridays: 9:00~11:30
Time Limit for Processing: In case both
entrusting and entrusted parties are the drug production enterprises in
Shanghai: within 30 working days for the first review;
In case the entrusting
party is the drug production enterprise in Shanghai, and the entrusted party is
the drug production enterprise in other province, autonomous region or
municipality of China: within 10 working days for the first review; and
In
case the entrusting party is the drug production enterprise in other province,
autonomous region or municipality of China, and the entrusted party is the drug
production enterprise in Shanghai: within 20 working days for the first
review.
Qualified Application Subject:
Scope of
Application:
Application for first review of drug production on commission by
entrusting or entrusted drug production enterprises in
Shanghai.
Qualifications/Prerequisites for Application:
1 The entrusting
party of the drug production on commission shall hold the registered number of
approval for the very drug; and
2 The entrusted party of the drug production
on commission shall hold the License of Drug Production and Certificate of Drug
GMP complying with production of the very drug, and possess the conditions
ensuring the production and quality of production of the very
drug. |
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