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NMPA Releases Administrative Measures for the Certification of Good Management Practices for Non-Clinical Research of Drugs (Draft for Comments)

 Last Update: 2022-10-25
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In order to further standardize the certification and supervision and management of the Good Management Practice (GLP) for Non-clinical Research of Drugs, the State Food and Drug Administration organized and revised the Administrative Measures for the Certification of the Good Management Practice for Non-clinical Research of Drugs, which is now open for comments
.

Please fill in the feedback form and give feedback to the email before November 21, 2022: yjjyjc@126.
com, and the subject of the email should indicate "Feedback on GLP Certification Management Measures"
.

Attachments: 1.
Measures for the Administration of Certification of Good Management Practices for Non-Clinical Research of Drugs (Draft for Comments)

2.
Feedback form

Comprehensive Department of the State Food and Drug Administration

October 21, 2022

Annex 1

Measures for the Certification of Good Management Practices for Non-Clinical Research of Drugs

(Draft for Solicitation of Comments)

Chapter I General Provisions Article 1 In order to strengthen the supervision and management of non-clinical research of drugs and standardize the certification and management of good management practices (GLP) for non-clinical research of drugs, according to the These Measures
are formulated by laws, regulations and rules such as the Drug Administration Law of the People's Republic of China and the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China.
Article 2 GLP certification refers to the implementation of GLP by the State Medical Products Administration for non-clinical safety evaluation research institutions of drugs according to the application The process of
checking and assessing the situation.
Article 3 The State Medical Products Administration is in charge of the national GLP certification management work, and is responsible for the establishment of the GLP certification management work system and administrative examination and approval
.
The Food and Drug Inspection Center of the State Medical Products Administration (hereinafter referred to as the Verification Center) is responsible for the review of GLP certification related materials, on-site inspection, comprehensive assessment, and supervision and inspection
.
The Administrative Matters Acceptance Service and Complaint Reporting Center of the State Medical Products Administration (hereinafter referred to as the Acceptance and Reporting Center) undertakes the acceptance of GLP certification, the preparation and delivery of
certificates, etc.
The provincial-level drug regulatory department is responsible for the daily supervision and management of drug non-clinical safety evaluation research institutions within its administrative region, organizing supervision and inspection, and investigating and punishing illegal acts
.
Chapter II: Application and Acceptance Article 4 Where a drug non-clinical safety evaluation institution intends to carry out a drug non-clinical safety evaluation study for drug registration application, it shall apply for GLP Certification
.
Article 5: Drug non-clinical safety evaluation research institutions applying for GLP certification (hereinafter referred to as the application institutions) shall be legal persons
.
The applicant institution may apply for GLP for one or more trial projects according to the research conditions of the institution Certification
.
The applicant institution shall carry out non-clinical safety evaluation studies
of drugs in accordance with the requirements of GLP and the relevant technical guidelines published by the National Medical Products Administration.
Each pilot should have completed at least one study before
applying.
Article 6 The applicant institution shall, in accordance with regulations, submit the " Application Form for Drug Non-Clinical Research Good Practice Certification and application materials
.
Copies of the relevant supporting documents in the application materials should be affixed with the official seal
of the applicant organization.
Article 7 The Acceptance and Reporting Center shall make a decision on whether or not to accept the application within 5 days from the date of receipt of the application materials.
and inform the applicant institution and the provincial drug regulatory department
where the applicant is located in writing.
The Acceptance and Reporting Center shall transmit the application materials to the Verification Center
within 3 days of acceptance.
Chapter III: Data Review and On-site InspectionArticle 8: The verification center receives an application After the information, the review
of the information should be completed within 10 days.
Where supplementary information is required, the verification center shall notify the applicant body in writing at one time of all the contents
requested to be supplemented.
The applicant institution shall submit all supplementary materials
as required within 20 days.
If the verification center finds that there are substantive deficiencies in the application materials that cannot be corrected, it will no longer require the applicant institution to supplement the information, and will make a review conclusion of disapproval based on the existing application materials, explain the reasons, and report to the State Medical Products Administration for approval
.
Article 9: Where the review of materials meets requirements, the verification center shall formulate an inspection plan within 20 days and organize the implementation of on-site inspections
。 The verification center shall notify the applicant institution and the local provincial-level drug regulatory department of the on-site inspection arrangements
5 days in advance.
The on-site inspection time is generally 3 to 5 days, which can be adjusted
appropriately according to the needs of the inspection work.
Article 10 The provincial-level drug regulatory department where the applicant institution is located shall send observers to participate in the on-site inspection, and shall be responsible for coordinating and liaising with the work related to the
on-site inspection of GLP.
Article 11: The applicant institution shall actively cooperate with the work of the inspection team, and in accordance with the requirements of the inspection team, clarify the person in charge of the inspection site and open relevant venuesor area, cooperate with the inspection of relevant facilities and equipment, provide relevant materials required for inspection, and truthfully answer the inquiry
of the inspection team.
Article 12 On-site inspections shall implement the team leader responsibility system, and the inspection team shall have two or more GLPs The composition of the personnel with the qualifications of
the inspectors.
Inspectors should be familiar with and understand relevant professional knowledge, and may hire relevant experts to participate in on-site inspections
when necessary.
Inspectors and inspection experts shall sign a conflict of interest declaration and confidentiality agreement
.
When there is an interest relationship with the inspected institution or there are other circumstances that may affect the fairness of the on-site inspection results, it shall be actively declared and avoided
.
The commercial secrets, undisclosed information, or confidential commercial information of the inspected institution shall be kept confidential
.
Article 13: Before on-site inspections begin, the inspection team shall present the authorization documents to the applicant body and inform the composition of the inspection personnel Announce inspection discipline, put forward inspection requirements, and clarify the scope of inspection, inspection methods and inspection schedules
.
Article 14 The inspection team shall conduct inspections in accordance with the inspection plan and GLP inspection points, record the inspection situation in detail, and review the findings during the inspection The problem should be truthfully documented and evidence should be collected if necessary
.
GLP checkpoints are developed
by the verification center.
For each pilot project requested by the institution, the inspection team shall select at least one study for examination
.
Article 15: The inspection team shall review and summarize the problems found during the inspection, and write on-site inspection opinions
.
During the deliberation period of the inspection team, the personnel of the applicant institution shall recuse themselves
.
Article 16: Before the on-site inspection is completed, the inspection team shall give feedback on the on-site inspection to the applicant institution and report the problems found during the inspection
。 The applicant body shall confirm the feedback from the inspection team, and if there is an objection, it may raise different opinions, give explanations and explanations
.
The inspection team shall further verify and make necessary adjustments
to the on-site inspection opinions and the content related to problems found during the on-site inspection in light of the verification situation.
On-site inspection opinions shall be signed
by all members of the inspection team and observers.
Problems discovered during on-site inspections shall be signed by all members of the inspection team, observers, and the responsible person of the applicant institution, and affixed with the official seal
of the applicant body.
Each party has one copy
.
Where the applicant body refuses to sign and seal, the inspection team shall indicate
it in the on-site inspection opinion.
The applicant body shall separately explain in writing the refusal to sign and seal, which shall be signed by the responsible person of the application institution, and shall be affixed with the official seal of the application institution and submitted to the inspection team
.
After the on-site inspection, in addition to the supporting evidence materials submitted to the verification center, the inspection team shall return other materials to the applicant institution
.
Article 17: Within 5 days after the on-site inspection is completed, the inspection team shall review the opinions of the on-site inspection, the problems discovered during the on-site inspection, Inspector records and related information are submitted to the verification center
.
Article 18: The applicant institution shall submit a rectification report or rectification plan
to the verification center within 20 days after the on-site inspection.
If it is not submitted within the time limit, it will be deemed that it has not passed GLP certification and will be handled
in accordance with the non-approval.
After the applicant institution completes the rectification in accordance with the rectification plan, it shall promptly report the rectification situation to the verification center
.
Article 19: The verification center shall conduct on-site inspection opinions in conjunction with the rectification report or rectification plan of the applicant institution Conduct a comprehensive assessment
.
When necessary, on-site inspections
of the rectification of the applicant institution may be carried out.
The verification center shall complete the comprehensive assessment within 20 days of receiving the rectification report or rectification plan, make an audit conclusion, and submit it to the State Medical Products Administration for approval
。 If on-site inspection of rectification is required, the time limit for comprehensive assessment can be extended by 10 days
.
Article 20: The verification center establishes a working mechanism for communication and exchange of drug GLP certification, and communicates with the applicant institution on the supplementary materials to be requested, problems found in on-site inspections, and review conclusions that are not approved
。 Article 21: The verification center is to organize and carry out work
such as data review, on-site inspection, and comprehensive assessment in accordance with the time limits provided in these Measures.
The time for the applicant institution to supplement information, give feedback, and carry out rectification shall not be included in the time limit for the work of
the verification center.
Chapter IV Approval, Certificate Issuance and Certificate Management Article 22 The State Medical Products Administration shall:When the approval decision
is made within 20 days.
If it meets the GLP requirements, it will be approved and issued with a drug GLP certification certificate (hereinafter referred to as GLP certificate)
。 The GLP certificate is valid for 5 years
.
If it does not meet the requirements of the GLP, a written decision not to approve shall be made and the reasons
shall be explained.
Article 23 The matters and contents stated in the GLP certificate are changed GLP agencies should submit a change application
to the NMPA.
Applications for new test projects and addresses of new test facilities shall be submitted in accordance with the requirements of Article 6 of these Measures, and the procedures and time limits for data review, on-site inspection, and approval shall be implemented
in accordance with the relevant provisions of these Measures.
Changes may not be made
without approval.
If the name of the institution, the registered address and the name of the institution specifically carrying out non-clinical safety evaluation research of drugs are changed, an application
for change shall be submitted within 30 days after the approval of the change by the market regulatory department or the approval of the change by the competent department at the higher level of the GLP institution.
The State Medical Products Administration shall go through the formalities
for modification within 30 days of receiving the application.
The State Medical Products Administration will reissue the GLP certificate according to the changed content, and withdraw the original GLP certificate, and the validity period of the changed certificate will remain unchanged
.
Article 24 In any of the following circumstances, the State Medical Products Administration shall cancel the GLP certificate in accordance with regulations: (1) Where the institution voluntarily applies for deregistration; (2) Refusing to reissue the GLP certificate or failing to apply for re-issuance after the expiration of the validity period of the GLP certificate; (3) Where the institution is terminated in accordance with law; (4) The GLP certificate has been revoked or revoked in accordance with law; (5) Other circumstances
where GLP certificates shall be revoked as provided by laws and regulations.
Article 25 Where an institution voluntarily applies for cancellation of some test projects, the State Medical Products Administration shall, on the basis of the institution's application, reissue GLP certificates
for uncancelled test projects.
The validity period of the reissued certificate remains unchanged
.
Article 26 The GLP institution shall submit an application
for re-issuance to the State Medical Products Administration within 6 months to 2 months before the expiration of the certificate.
If an application for reissuance is not submitted within the prescribed time limit, the non-clinical safety evaluation study
of the drug used for the drug registration application shall not continue to be carried out after the expiration of the certificate.
If the State Medical Products Administration grants the re-issuance, the research
may be carried out only from the date of granting the license.
Chapter V Supervision and Administration Article 27 GLP organization related to the quality management system, main personnel, When the test facility is changed, or other changes affect the operation of the quality management system, a written report
shall be submitted to the provincial drug regulatory department within 20 days from the date of the change.
The provincial drug regulatory department shall review the report and organize on-site inspections
when necessary.
Where the requirements are not met after review, the institution shall be requested to make corrections
within a time limit.
When there is a situation that may seriously affect the implementation of GLP, the provincial drug regulatory department shall promptly report the inspection results to the State Medical Products Administration
.
Article 28 GLP institutions shall report to the local provincial-level drug regulatory department for implementation in December of each year GLP reports
.
The content of the report should include the basic situation of the organization, the operation of the quality management system, the implementation of the research work, the problems existing in the implementation of GLP and the measures taken
.
Article 29 The provincial-level drug regulatory departments shall formulate GLPs in light of the actual conditions of GLP institutions within their respective administrative regions The institution has an annual inspection plan and carries out daily supervision and inspection, and follows up and inspects the problems found in previous inspections and inspections, and investigates and punishes violations of
laws and regulations in accordance with law.
The provincial drug regulatory department shall carry out daily supervision and inspection of GLP institutions at least once a year, which may be carried out
in conjunction with other inspection work.
Article 30 The provincial-level drug regulatory department shall, in January of each year, report the routine supervision and inspection carried out in the previous year and the annual report of the GLP institution to the State Medical Products Administration and send a copy to the verification center
.
Article 31 The Verification Center shall formulate GLPs in accordance with risk management principles The institution plans annual inspections and conducts supervisory inspections
.
Carry out at least 1<b3 for <b33>GLP institutions during the validity period of the certificate6> supervision and inspection can be carried out in combination with cause inspections and registration verifications.
Article 32 The GLP organization's annual inspection plan shall include the name of the GLP institution to be inspected, Check the time, check the content, etc
.
The inspection may be carried out without informing the inspected institution in advance, and a specific part of the quality management system of the GLP organization may be inspected, or a specific test item or study may be verified, and a comprehensive inspection
may be carried out if necessary.
Article 33 GLP institutions shall rectify the problems found in the inspection, Promptly report the rectification situation to the inspection department and the local provincial drug regulatory department
.
The provincial-level drug regulatory departments shall review the rectification of the institution in combination with the daily supervision situation, and conduct on-site inspections
when necessary.
Article 34 GLP institutions shall: Strictly implement the "Quality Management Practices for Non-clinical Research of Drugs", accept and cooperate with the inspection conducted by the drug regulatory department in accordance with the law, and shall not refuse, evade, delay or obstruct the inspection
for any reason.
If you refuse or do not cooperate with the inspection, the relevant inspection will be handled
in accordance with the requirements of the GLP.
Article 35 GLP is found during inspection Where there are potential safety hazards in the operation of the institution's quality management system, measures such as warnings, interviews, rectification within a time limit, and suspension of new non-clinical drug safety evaluation studies
shall be taken in accordance with Article 99 of the Drug Administration Law.
Article 36 The inspection found that the GLP institution did not comply with the non-clinical nature of the drug Those who study quality management practices shall be handled
in accordance with Article 126 of the Drug Administration Law.
Article 37 Where relevant circumstances are concealed or false materials are provided to apply for GLP certification, approval shall not be granted and shall be handled
in accordance with law.
Article 38 The drug regulatory department shall disclose the GLP certification situation and the results of supervision and inspection of the GLP institution in accordance with relevant regulations.
Investigation and handling of
illegal acts, etc.
Chapter VI Supplementary Provisions XXXIX Article The Health Bureau of the Logistics Support Department of the Central Military Commission shall be responsible for the GLP institutions under it in these Measures The supervision and management responsibilities of
provincial drug regulatory departments.
Article 40: The time limit provided for in these Measures is calculated
as working days.
Article 41: These Measures shall come into force
six months after promulgation.
On April 16, 2007, the former State Food and Drug Administration promulgated the "Quality Management Standard for Non-clinical Research of Drugs" The Measures for the Administration of Certification (Guo Food and Drug Administration [2007] No.
214) were abolished
at the same time.
Attachment: 1-1 Drug Non-Clinical Research Good Practice Certification Application Form 1-2 Drug Non-Clinical Research Quality Management Practice Certification application materials require 1-3 National Medical Products Administration drug GLP certification certificate

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