5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?

Mexico’s clinical trials comply with ICH’s GCP. 

Therefore, the investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

Not applicable. 

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

No, only wet signatures are allowed.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

No. 

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

The trial participant and/or his/her legal representative(s) or guardian(s), as well as two witnesses, must sign the ICF. The ICF should be dated, any updates must also be signed, and a copy of the amendments provided to the participant and/or his/her legal representative or guardian. If the participant does not know how to sign, he/she will provide a fingerprint and will need to designate someone to sign his/her name on his/her behalf. A copy of the signed ICF will be provided to the participant and/or his/her legal representative or guardian. The ICF must contain the document version and date.

Personal data is regulated under the Regulations to the Federal Law on the Protection of Personal Data held by Private Parties (Reglamento de la Ley Federal de Protección de Datos Personales en Posesión de los Particulares) (the Regulations), which entered into force on December 22, 2011. 

The Law regulates the collection and processing of any personal information by any private entity acting as a Controller or Processor, which impacts any sector that is involved in any sort of personal data collection or processing.

The appointment of a Data Protection Officer (person or department) by the Controller is mandatory.

http://biblioteca.udgvirtual.udg.mx/jspui/bitstream/123456789/1210/1/Reglamento%20de%20la%20ley%20federal%20de%20protecci%c3%b3n%20de%20datos%20personales%20en%20posesi%c3%b3n%20de%20los%20particulares.pdf

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

There is no specific guidance on this matter.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)?

There should be no out-of-pocket expenses for the patient.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range?

Participant stipends are permitted but there is no guidance on the allowable amounts.

5.9 Specific labeling requirements for clinical study product

Investigational product (IP) labeling in Mexico must comply with the requirements set forth in NOM-164-SSA1-2015, NOM-059-SSA1-2015, and the Guideline for Good Clinical Practice E6(R1) (MEX-32).

As delineated in NOM-059-SSA1-2015, the IP label must contain, at a minimum, the following information:

1. Name, address, and telephone number of the sponsor or main contact
2. Pharmaceutical form and route of administration
3. Lot number
4. Statement: “For clinical studies only”
5. Expiration date

NOM-164-SSA1-2015 also states that the IP label must indicate it is material under investigation. In addition, MEX-32 indicates the sponsor should verify the IPs are coded and labeled in a manner that protects the blinding, if appropriate.

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics?

Foreign manufacturers wishing to import IMP into Mexico must submit an application to COFEPRIS following approval of the clinical protocol. This submission must be made by a legal representative in Mexico.

The submission must include:

1. A GMP for the site of manufacture
2. A statement that the IMP is suitable for clinical use
3. Documents outlining the quality standards of the IMP

Three types of import permits may be issued:

1. A definitive import permit – which is for an unlimited time period.
2. A temporary import permit – for a specified time, not exceeding one year.
3. An import in transit – which covers the transportation period of the IMP, and which does not exceed 30 days.

5.11 What is the turn-around time to get an import permit?

A decision on an import permit will be issued within a maximum of 60 days.

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required?

There is no specific guidance on the location of destruction of materials.