MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
1.3 Categories of Pharmaceuticals and Medical Devices The GHL contains many classifications for medicines, including reference and generic/biocomparable drugs, prescribed and non-prescribed drugs, standard and controlled drugs, and so on. Medical devices are divided into three classes accord- ing to the risk they pose to human health: • class I – devices that are recognised in medical practice, have proven safety and efficacy, and are generally not introduced into the human body; • class II – devices that are recognised in medical practice, can vary in the way or volume in which they are manufactured and are regularly introduced into the human body (remaining in situ for less than 30 days); and • class III – new products, or those recently accept- ed by medical practice or that are introduced into the human body and remain in situ for more than 30 days. 2. Clinical Trials 2.1 Regulation of Clinical Trials Clinical trials are regulated by the following key instru- ments: • the GHL; • the CRSR; • Technical Standard NOM-012-2012-SSA3; • the Guidelines for Good Clinical Practice published by COFEPRIS; and • the Decree for the Operation of Ethics Committees, co-ordinated by the National Bioethics Commis- sion (ConBioetica). In general, clinical trials (Phases I–IV) must be: • preceded and supported by preclinical data; • conducted in accordance with scientific and ethical principles; • performed with the informed consent of the partici- pating human subjects; • executed under a research protocol; • overseen by a principal investigator; and
• performed in licensed health institutions. In addition, they must obtain the relevant approvals from a health institution, an ethics committee and COFEPRIS. Historically, the operation of ethics committees was largely self-regulated and based on international best practice. There was also a lack of co-ordination between COFEPRIS and ConBioetica. However, the Decree for the Operation of Ethics Committees (2012) provides a clearer legal framework for ethics commit- tees, establishing their structure and objectives, the role of their members and the requirement to be regis- tered with ConBioetica and COFEPRIS. Unfortunately, ConBioetica has accrued enormous regulatory delays, forcing serious consideration of litigation of the lack of response. Notably, the Guidelines for Good Clinical Practice (2012) make clear reference to international best practice, including standards developed by the Inter- national Conference on Harmonisation. These good clinical practices will be the basis of a move towards a certification system, for which COFEPRIS has already started to conduct inspections of research sites. The operation of contract research organisations (CROs) is not fully regulated, with references only found in the guidelines, but there are ongoing initiatives to address this, including a draft technical regulation on good clinical practices (NOM-262-SSA1-2024). Other regulatory measures have been introduced to promote Mexico as a place for conducting clinical research, including the following. • An important amendment to the RIS: Article 170 of the RIS originally required a certificate of free sale for the country of origin to be submitted as part of an application for obtaining marketing authorisa- tion (MA) for a drug produced abroad, such that it was not possible for Mexico to be the first coun- try of registration. In 2012, however, this rule was changed to make it possible to submit a clinical trial report instead, provided that the Mexican population was included in the trial.
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