4. Regulatory Authority (RA)/ Competent Authority (CA)

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant. 

The following documentation must be submitted to COFEPRIS as part of the approval process:

1. Authorizations, Certificates, and Visits form (original) (MEX-25).
2. Proof of payment of rights (Original and two copies).
3. Research protocol (original and one copy).
4. Acceptance letter from research institution head and responsible principal investigator (PI).
5. Sponsor letter of acceptance.
6. Follow-up letter from sponsor providing monitoring/auditing plan.
7. Model letter of informed consent in Spanish.
8. Informed consent document (original).
9. Study schedule (original and one copy).
10. A letter describing the approximate total quantity of investigational products (IPs) requiring importation at each stage of the study; the letter serves as an acknowledgment of information, not authorization (original and one copy).
11. Copy of the study’s current financial or insurance budget.
12. Copy of current REC and Research Committee registration and Biosafety Committee registration (where applicable).
13. Favorable opinion of REC, Research Committee, and where appropriate, Biosafety Committee (original and one copy).
14. REC member list.
15. REC member letters recusing themselves if they are on the research team.
16. REC letter describing the study follow-up process.
17. Letter of No Conflict of Interest and Confidentiality signed by REC members.
18. Copy of sanitary license or notice of operation.
19. Letter of authorization to carry out the research, signed by health institution owner (original and one copy).
20. Where applicable, a copy of the agreement between research centers that have agreements for emergency medical care with other institutions.
21. A letter describing resources available for emergency management (original and one copy).
22. Adverse event report confidentiality letter from the principal investigator (PI) (original and one copy).
23. Summary of PI’s professional record/official professional documentation issued and registered by competent educational authorities (original and one copy).
24. Summary of academic preparation and experience of medical personnel, paramedics, and other experts involved in the study (original and one copy).
25. A letter describing the research team’s delegation of responsibilities.
26. Investigator’s manual (original and one copy).
27. A letter describing the sponsoring institution’s resources for the study’s development (original and one copy).
28. Copy of document indicating that the drugs used in the study comply with Good Manufacturing Practices (GMPs) and have the expected quality characteristics for IPs to be used in the study, or letter documenting GMPs.
29. Status of stability studies, or letter documenting IP stability studies comply with applicable regulations.

4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process. 

COFEPRIS must approve a request for research protocol authorization within 30 working days from the day following an application’s filing. COFEPRIS’s Sanitary Authorization Commission (Comisión de Autorización Sanitaria (CAS)) is responsible for recording, evaluating, and issuing opinions on authorization requests for research protocols in human beings. CAS’s Clinical Trials technical area conducts its work via COFEPRIS’s Integral Services Center (Centro Integral de Servicios (CIS)), a public service system established to facilitate the processing of agency procedures and services.

The applicant must submit an application to the CIS to request protocol authorization or modification. Protocol modifications may be submitted to amend research procedures, to remove or add research center(s)/research institution(s), or to provide updated clinical and/or preclinical security/safety information. 

A pre-evaluation assessment also requires CAS’s Clinical Trials technical area to issue a response within a maximum of 30 business days as long as the applicant notifies the Clinical Trials technical area that his/her application was submitted with the pre-evaluation assessment. A UHAP pre-assessment may result in a favorable or unfavorable review. If the review is unfavorable, the applicant is required to respond within 30 calendar days to all the issues raised, or the submission will be designated “rejected,” and the review will be concluded and returned to the applicant.

Once the applicant obtains official authorization from COFEPRIS, he/she has a maximum of five working days to enter this information into the National Registry of Clinical Trials (Registro Nacional de Ensayos Clínicos (RNEC)) database. The RNEC is in charge of the CAS’s Clinical Trials technical area and serves as the interface through which applicants are required to submit their application documentation in order to maintain an updated national inventory of clinical studies involving humans and/or their biological samples.

4.3 Does the regulation support electronic submission?

Yes, applicants must submit one hard copy of the application and one electronic copy on CD-ROM or USB.

https://www.gob.mx/sre/prensa/new-cofepris-digital-platform-for-research-and-clinical-trials-digipris-sets-the-pace-in-regulation?idiom=en 

4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?

Yes, applications are required to be provided by the principal investigator with an acceptance letter from the research institution.

https://www.gob.mx/cms/uploads/attachment/file/551379/Ventiladores_Niveles_Madurez_Tecnol_gica_080520.pdf

4.5 Please describe the process of RA/CA submission for clinical trial approval. 

Mexico also offers a pre-assessment evaluation that helps to facilitate COFEPRIS’s review. Rather than submitting the application directly to the CIS, the applicant may first choose to obtain a pre-assessment evaluation of his/her application through an Enabled Pre-Assessment Support Unit (Unidad Habilitada de Apoyo al Predictamen (UHAP)) within the Coordinating Commission of National Institutes of Health and High Specialty Hospitals.

4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.

RA does not provide written acknowledgment but if the applicant chooses to send the application requesting protocol authorization directly to COFEPRIS, then the CIS will assign a reference number to the application and send it to the Clinical Trials technical area in CAS for technical evaluation. If the EC responds favorably to the initial request, then the authorization is approved and the clinical study may begin. However, if the request is rejected, an objection is issued and the applicant must resubmit a request for continued processing after addressing all the issues raised. In either case, the applicant must use the CIS reference number to track the official resolution of either an authorization or an objection to the request.

https://www.gob.mx/cms/uploads/attachment/file/149028/Gu_a_de_Sometimiento_COFEPRIS-09-012_MODIFICACI_N.pdf

4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)

The cost of submitting a clinical trial application to COFEPRIS is around 600 Mexican Pesos (equivalent to USD335).

4.8 Does RA/CA accept checks or can payment be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?

Applicants should make payments for these procedures and services through an authorized credit institution using E5cinco. 

E5cinco is an electronic scheme created to enable users to submit the Payment of Rights, Products, and Uses (DPAs) to a participating credit institution through its Internet portal or banking window. See also MEX-51 and MEX-6 for detailed DPA payment instructions via E5cinco.

4.9 Is there any guidance tool available for making an electronic application? If yes, provide the link and/or step-by-step instructions.

This link provides a document labeled INFORMATION FOR EVALUATION IN ELECTRONIC in Spanish.

https://www.gob.mx/cms/uploads/attachment/file/369736/Requisitos_para_presentar_la_informaci_n.pdf

4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?

No.