MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
• class II – devices that are recognised in medi- cal practice, can vary in the way or volume in which they are manufactured and are regular- ly introduced into the human body (remaining in situ for less than 30 days); and • class III – new products, or those recently accepted 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 instruments: • the GHL; • the CRSR; • Technical Standard NOM-012-2012-SSA3; • the Guidelines for Good Clinical Practice pub- lished by COFEPRIS; and • the Decree for the Operation of Ethics Com- mittees, co-ordinated by the National Bioeth- ics Commission. 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 participating 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 approv- als from a health institution, an ethics committee and COFEPRIS.
Historically, the operation of ethics committees was largely self-regulated and based on inter- national best practice. There was also a lack of co-ordination between COFEPRIS and the National Bioethics Commission (ConBioetica). However, the Decree for the Operation of Eth- ics Committees (2012) provides a clearer legal framework for ethics committees, establishing their structure and objectives, the role of their members and the requirement to be registered with ConBioetica and COFEPRIS. Unfortunately, ConBioetica has accumulated enormous regu- latory delays, forcing serious consideration of litigation of the lack of response. Notably, the Guidelines for Good Clinical Prac- tice (2012) make clear reference to international best practice, including standards developed by the International 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 organisa- tions (CROs) is not fully regulated, with refer- ences only found in the guidelines, but there are ongoing initiatives to address this, including the draft PROY-NOM-262-SSA1-2024 on good clini- cal practices. Other regulatory measures have been intro- duced to promote Mexico as a place for con- ducting clinical research, including the following. • An important amendment to the RIS – Article 170 of the RIS originally required a certifi- cate of free sale of the country of origin to be submitted as part of an application for obtaining marketing authorisation (MA) for a drug produced abroad, such that it was not possible to have Mexico as the first country
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