I.Project name: Approval of commissioned drug production
II.Contents of licensing: Examination and approval of commissioned production of〔injections, biologics (excluding vaccines and blood products) and drug production commissioned across provinces, autonomous regions and municipalities]
"Drug Administration Law of the People's Republic of China", "Regulations for Implementation of the Drug Administration Law ", "Provisions for Supervision and Management of Drug Production"
IV.Fees: No charge
V.Quantity restrictions: No quantity limit for the licensing
VI.List of application documents:
Data number (1) Application form for commissioned drug production
Data number (2) Copies of principal’s and entrusted party’s "drug production license" and "business license";
Data number (3) Copy of the trustee’s "Good Manufacturing Practice" certificate;
Data number (4) Principal’s evaluation of the trustee’s production and quality assurance conditions:
Data number (5) Copies of the certifying documents approving the Principal’s proposal of entrusted production, and the attachment shall cover quality standards, production processes, and real samples of packages;
Data number (6) The proposed package, labels, package insert proofs and color codes.
Data number (7) Contract for commissioned production;
Data number (8) Testing report issued by the trustee’s provincial drug testing institutions for three consecutive batches of products. For commissioned production of biological products, its three batches of samples should be extracted and sealed by trustee’s provincial drug testing institutions, NIFDC is responsible for testing and providing test report;
Data number (9) Evaluation decisions made by the (food) drug administration departments of the provinces, autonomous regions and municipalities in jurisdiction of the trustee, for inspection of the enterprise’s technical personnel, plants, facilities, equipment and other production conditions and capabilities, as well as quality inspection agencies, inspection equipment and other quality assurance systems.
VII.Requirements for application dossier:
(I)General requirements for the dossier:
The first page of the dossier is list of application documents, which shall be arranged in order specified in chapter IV of the “Provisions for Supervision and Administration of Drug Production”. The dossier shall be distinguishable with clear markers, and the name and serial number of the dossier shall be indicated. The full set of dossier shall be punched and bound into a book.
The dossier shall be printed in A4 size paper, the left margin shall be not less than 3cm, the page number shall be marked on the bottom right corner; the cover shall mark the name of the applying enterprise (Chinese characters not less than font-size junior 4 in Song typeface, English not less than font-size 12), the contents should be complete, clear, and shall not be altered.
1 full set of the original "Application Form for Commissioned Drug Production", 1 full set of the original dossier for commissioned drug production. The application form should be accurate and complete with clear handwriting.
The pictures and drawings annexed to the dossier must be clear and legible, should not be copied or color inkjet printed pictures.
The applicants should send E-mail, along with the mail or submission of their application dossier, the electronic version of the application form to the following e-mail address: firstname.lastname@example.org, which is dedicated for drug registration.
(II)Specific requirements for application document:
1.Application form for commissioned drug production
The application form is the basic document for GMP certification, and the basis and essentials for Drug Administration department’s approval of the application, and format review of GMP certification application, therefore it must be filled out in an accurate and standardized manner in compliance with the explanatory notes.
Specify the name of the principal and the trustees, the legal representative, certified dosage forms, intended commissioned varieties and their drug approval numbers.
Evaluation decisions made by the (food) drug administration departments of the provinces, autonomous regions and municipalities in jurisdiction of the trustee, for inspection of the enterprise’s technical personnel, plants, facilities, equipment and other production conditions and capabilities, as well as quality inspection agencies, inspection equipment and other quality assurance systems.
The range of application for commissioned drug production refers to the applications for entrusted production of injection, biological products (excluding vaccines and blood products) and entrusted production across the provinces, autonomous regions and municipalities, CFDA is responsible for application acceptance and approval.
Entrusted production shall not apply to blood products, vaccines and other pharmaceutical products regulated by CFDA.
The commissioned the production of narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive drugs, pharmaceutical precursor chemicals shall be handled in accordance with relevant laws and regulations.
2.Application documents for commissioned drug production
Principal and entrusted party’s "drug production license" and "business license" copies: the production scope of the "Drug production license" shall cover the entrusted dosage forms, the addresses in the copies of business license shall be consistent with the enterprises registered address in "drug production license", and the legal representative shall be the same person.
Copies of the trustee’s "Good Manufacturing Practice" certificate: both parties must have GMP certified production facilities commensurate with the proposed varieties under entrustment. The production address of the "Application form for commissioned drug production "shall be consistent with the Address in GMP certificate of the corresponding Dosage forms.
Principal’s evaluation of the trustee’s production and quality assurance conditions: whether the trustee has appropriate conditions for entrusted drug production.
Copies of the certifying documents approving the Principal’s proposal of entrusted production, and the attachment shall cover quality standards, production processes, and real samples of packages, labels and package inserts in minimum packaging.
The proposed package, labels, package insert proofs and color codes. The quality standards for commissioned drug production should implement national drug quality standards. The formulation, manufacturing process, packaging specifications, labels, package inserts, approval numbers, etc. should be identical to those in the original approval documents. The packaging, labels and package inserts of the entrusted drugs shall be clearly marked with the name and registered address of the commissioning party, and the name and production address of the entrusted party.
Contract for commissioned production; The contract for commissioned drug production signed by the two sides should include the rights and obligations of both parties, and specify their rights and obligations in the commissioned drug production technology, quality control, and other aspects, and shall comply with the relevant drug administration laws and regulations of China.
Testing report issued by the trustee’s provincial drug testing institutions for three consecutive batches of products.For commissioned production of biological products, its three batches of samples should be extracted and sealed by trustee’s provincial drug testing institutions, NIFDC is responsible for testing and providing test report; The testing report for three successive batches of products should be original and stamped with the official seal of provincial drug control institutions. The testing report shall certify that the drugs produced by the trustees are in compliance with the statutory quality standards for drugs.
VIII.Application process diagram:
After the application is filed to the Administrative Acceptance Service Center, and the application dossier submitted is in accordance with the list in VI of this Notice, the format examination shall be conducted by the work staff of the Center in accordance with the "Provisions for supervision and administration of drug production". If the application items are not subject to administrative examination and approval according to law, the decision of non-acceptance shall be immediately made, and the applicant shall be informed to apply to related administrative institutions; If the application items are not within the purview of the executive authorities, the decision of non-acceptance shall be immediately made, and the applicant shall be informed to apply to related administrative institutions; If the application dossier have errors that can be corrected on the spot, the applicant shall be allowed to correct on the sport; in case that application dossier are incomplete or do not meet the statutory form, the applicant should be informed at once to enrich or rectify the relevant contents on the spot or within five days; If the applicant is not informed within the above-mentioned period, the application shall be deemed as accepted from date of receipt of application materials; If the application dossier are within the scope of the administrative institutions, the application materials are complete and comply with the statutory form, or the applicant has submitted all application materials in accordance with the requirements of the administrative authorities for enrichment or correction, the application shall be accepted for administrative examination and approval.
(II)Review and licensing decisions
CFDA should review the application and make decision, in accordance with the "Provisions for supervision and administration of drug production", within 20 working days as from the acceptance of application; if a decision cannot be made within 20 workdays, an extension of 10 workdays can be granted with the consent of CFDA leaders, and the Principal shall be informed of the grounds for extension.
After reviewing, qualified applications shall be approved, and the "Approval Document for Commissioned Drug Production" shall be issued to the principal within 10 days as from the date for written approval decision; for non-compliance, the principal shall get a Notice in writing explaining the reasons, while informing its legal right to apply for administrative reconsideration or bring an administrative lawsuit.
X.Commitment time frame:
the administrative approval decision shall be made within 20 days from the date of acceptance.
XI.License validity and renewal:
The validity period of the "Approval Document for Commissioned Drug Production" shall not exceed two years, and shall not exceed the expiration date set forth in the drug registration approvals. If commissioned production is still necessary after the expiry of "Approval Document for Commissioned Drug Production", the commissioning party shall apply for extension 30 days prior to expiry.
XII.Annual inspection or annual review of the license: None
XIII.Authority of Implementation:
Implemented by: CFDA
Accepted at: CFDA Administrative Service Center
XIV.Institutions for inquiries and complaints:
Complaints: CFDA Bureau of Investigation and Enforcement, Department of Legal Affairs
Note: The time frame of this Notice counts on working days, excluding legal holidays