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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Any research on human beings must be approved by the Federal Commission for Protection Against Sanitary Risk (COFEPRIS). Research can include testing new medicinal products and new uses, as well as dosages and administration routes for already approved medicinal products. Essentially, the main requirements for an application for authorisation from COFEPRIS include:
- approval by an independent ethics committee registered with the Ministry of Health;
- approval by the medical institution or institutions where the clinical trials will be conducted;
- COFEPRIS approval for institutions to conduct clinical trials;
- clinical trial protocol (including a schedule and the approximate amount of medicinal products to be imported);
- written informed consent templates;
- pre-clinical and clinical data that justifies conducting the research;
- a description of available resources to conduct the research and to address emergencies (including a statement of sponsorship); and
- a written letter by the qualified investigator acknowledging his or her responsibilities, and data from the qualified investigator and his or her staff.
Medical assistance and financial indemnification for damage caused by the clinical trial must be provided to research participants.
How robust are the standard good clinical practices followed in your jurisdiction?
Good clinical practice in Mexico is well regulated. However, although the regulation is robust, there is scope for improvement. Currently, efforts are in place to reach international standards.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The Health Law Regulations for Health Research and the Official Mexican Standard (NOM) for health research in human beings provide the guidelines and standards for the clinical trial protocol, including rules concerning documentation, compilation, confidentiality and reports.
Essentially, according to the NOM for health research in human beings, any clinical trial must be conducted following ethical guidelines regarding the dignity, rights and welfare of human beings.
Clinical trials can specify certain steps or goals to be achieved. The principal researcher must compile a final technical report for the clinical trial. When clinical trials last longer than one year, annual technical reports for the health authorities must be compiled. Accordingly, NOMs apply to:
- medicinal products labelling (NOM-072- SSA1-2012);
- pharmacovigilance (NOM-220-SSA1-2012);
- interchangeability and bio-comparability tests (NOM-177-SSA1-2013);
- biological products (NOM-257-SSA1-2014);
- good manufacturing practices for medicinal products (NOM-059-SSA1-2015); and
- active ingredients (NOM-164-SSA1-2015).
What are the informed consent obligations with respect to clinical trial subjects?
Investigators must collect informed consent from research participants in a formal written document signed by two witnesses. A participant must grant consent on a voluntary basis, with sufficient access to information regarding potential risks and benefits. Participants maintain the right to give up the research at any time. Investigators must ensure post-care for patients until it is clear that no damage has occurred as a result of the research.
What are the insurance requirements for clinical trials?
According to NOM-012-SSA3-2012, regarding clinical trials in human beings, the clinical trial budget should include compensation to which the subject of investigation will be legally entitled in case of damages directly related to the clinical trial. Where appropriate, this financial fund may be covered under study insurance.
What data protection issues should be considered when conducting clinical trials?
The primary legislation is the Personal Data Protection Law. This legal framework requires the person or entity in charge of compliance to observe consent, quality, purpose, loyalty, proportionality, responsibility, security and confidentiality requirements. It relates to the pharmaceutical legal framework (eg, health research, clinical trials and pharmacovigilance).
The NOM for health research in human beings requires protection of access, rectification, cancellation and opposition rights of research participants by deferring to the Personal Data Protection Law. Investigators and committees of the institution where the research is conducted must protect participants’ personal data in the research and publishing stages. Investigators must collect informed, valid consent from research participants.
The NOM for pharmacovigilance also recognises the protection of personal data of research participants and healthcare professionals submitting reports by deferring to the Personal Data Protection Law.
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