I.Project name: Approval of commissioned drug production
II.Contents of licensing: Examination and approval of extension 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) Copy of Commissioned drug production approval letter issued last time
Data number (5) Production and quality summary of the last commissioned production
Data number (6) Documents certifying the changes in the "Approval Document for Commissioned Drug Production" as compared with the previous one.
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.
3.A copy of the previously approved "Approval Document for Commissioned Drug Production": 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. Verify if the date for application is 30 days prior to expiry of the "Approval Document for Commissioned Drug Production", if the drug varieties and specifications are identical with those in the previous entrustment.
4.Summary report of the production and quality status during the previous entrustment: the number of batches produced, quality management situation and quality inspection results.
5.Documents certifying the changes in the "Approval Document for Commissioned Drug Production" as compared with the previous one: During the last entrusted manufacturing, if changes occurred to the name and address of drug manufacturers, to the package, approval documents, quality standards of the commissioned products etc., the certifying documents after the changes shall be provided.
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". Where the application item is not subject to administrative approval according to law, a decision of non-acceptance shall be notified to the applicant immediately. Where the application item is not within the functions of the administrative authority, a decision of non-acceptance shall be made immediately, and the applicant shall be informed to launch the application to relevant administrative authority. Where in the application dossier, there are errors that can be corrected on the spot, the applicant shall be allowed to make the corrections on the spot. Where the application dossier is incomplete or does not meet the statutory format, the applicant shall be informed of all the supplements and amendments to be made once and for all 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. Where the application dossier is within the functions of the administrative authority, the application materials are complete and comply with the statutory format, or where the applicant has submitted all supplements and amendments in accordance with the requirements of the administrative authority, the application for administrative approval shall be accepted.
(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