Preclinical & Clinical Trial Requirements
Conducting preclinical or clinical trials in Mexico? Get the legal lowdown here. Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for GBP 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
Clinical trials for innovator biological products must take place in Mexico when the product is to be manufactured in Mexico. For products manufactured abroad, the Ministry of Health can request that a clinical trial takes place in Mexico when the Sub-Committee on Evaluation of Biotechnological Products of COFEPRIS considers that this is necessary.
2. How are clinical trials funded?
The primary legislation for clinical trials is the Health Law Regulations for Health Research (Reglamento de la Ley General de Salud en Materia de Investigación para la Salud) (RLGSMIS) and the NOM for Health Research in Human Beings (NOM-012-SSA3-2012).The Guideline for Good Clinical Practice E6(R1) is taken into account.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
This legislation is enforced by the Ministry of Health through COFEPRIS.
Preclinical data must be collected to justify whether clinical trials can be conducted.
The RLGMIS requires measures to ensure that the investigator does not have conflict of interest, to:
- Protect the rights of research participants.
- Maintain accurate results.
- Allocate resources.
The RLGMIS and the 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 conducted following ethical guidelines and must always respect 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, the following NOMs apply for:
- Medicinal products labelling (NOM- 072- SSA1-2012).
- Pharmacovigilance (NOM-220-SSA1-2016).
- Interchangeability and biocomparability tests (NOM-177-SSA1-2013).
- Biological products (NOM-257-SSA1-2014).
- Good manufacturing practices for medicinal products (NOM-059-SSA1-2015).
- Active ingredients (NOM-164-SSA1-2015).
Clinical protocols must be approved by COFEPRIS.
4. What are the requirements for consent by participants in clinical trials?
Investigators have to collect informed consent from research participants in a formal written document, also signed by two witnesses. Basically, the validity requirements for consent are that a participant grants it on a voluntary basis, with capacity to do so and sufficient information (knowing the potential risks and benefits). Participants keep the right to give up the research anytime.
Investigators must ensure post-care for them, until it is clarified that there are no damages derived from the research.
5. May participants in clinical trials be compensated?
According to the Official Mexican Standards regarding the Clinical Trials in Human Beings (NOM-012-SSA3-2012), the clinical trials budget should include compensation to which the subject of investigation will be legally entitled.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
Medical assistance and financial indemnification for damage caused by the clinical trial must be provided to research participants, in case of damages directly related to the same; where appropriate, this financial fund may be covered under study insurance.