Life Sciences – Multi-jurisdictional Guide 2012: Mexico

by Alejando Luna


1. What is the regulatory framework for the authorisation,  pricing and reimbursement of drugs, biologicals and devices (as they are termed in your jurisdiction)?


The main regulatory framework in relation to medical products is set out in the following federal laws:

– General Health Law (Ley General de Salud) (LGS).

– Health Law Regulations (Reglamento de Insumos para la

Salud) (RIS).

– Official Mexican Standards (Norma Oficial Mexicana) (NOMs).


Regulatory authorities

The authority responsible for enforcing the regulatory framework in relation to medicines is the Federal Commission for Protection against Sanitary Risk (Sitio Oficial de la Comisión Federal para  la Protección contra Riesgos Sanitarios) (COFEPRIS) (see box, The regulatory authority), which is part of the Ministry of Health (Secretaria de Salud)…

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