Medicinal Product Regulation And Product Liability In Mexico: Overview May 2017

REGULATORY OVERVIEW

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

   Legislation

   The primary legislation for medical products is:

   The General Health Law (Ley General de Salud) (General Health Law). The Health Law Regulations (Reglamento de Insumos para la Salud). The Official Mexican Norms (Normas Oficiales Mexicanas) (NOMs). Mexican Pharmacopoeia. Regulatory authorities

   The regulatory authority in this field is the Federal Commission for Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS) (www.cofepris.gob.mx) which is an administrative agency of the Ministry of Health (Secretaria de Salud).

2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

   Both biologics and combination products must have marketing authorisation from COFEPRIS. Roughly, biologics are classified into:

   Biologics of reference (usually innovators). Biocomparables, a term used instead of biosimilars, in view of social context issues with the term in Spanish (similares). Requirements and application timeframes differ in each case.

   Given their particular features, combination products can be classified as either drugs (drug/biologic) and/or medical devices (drug/device). Requirements and application timeframes differ in each case. A combination product may require separate drug or biologic and medical device approvals (see Questions 3. and 9).

3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

   The primary legislation for medical devices and diagnostics is the General Health Law, its regulations and the NOM for good manufacturing practices regarding medical devices (NOM-241-SSA1-2012).

   According to their use, Article 262 of the General Health Law classifies medical devices into:

   Medical equipment. Prosthetics, orthotics and functional supports. Diagnostic agents. Dental supplies. Surgical and healing materials. Hygiene products. Marketing authorisation requirements for these devices depend on the level of risk involved in their use, according to a threefold classification:

   Class I. Products well-known in medical practice for which safety and efficacy have been proven. They are not usually introduced into a patient's body. Class II. Products well-known in medical practice, but may have material or strength modifications. If introduced, they remain in a patient's body for less than 30 days. Class III. Products either recently accepted in medical practice or remain in a patient's body more than 30 days. COFEPRIS analyses both medical devices and, if applicable, software that enables them to work. Conversely, mobile medical applications are a new area that COFEPRIS may address in future by particular regulations, especially if they represent health risks.

   As an incentive, applicants can benefit from a special procedure for certain devices to be approved in Mexico, which have been previously approved by the:

   US Drug and Food Administration. Health Canada. This procedure is essentially based on the dossier filed with the foreign regulatory agency, to reduce approval timeframes by up to 30 working days. Industry participants have welcomed these new rules, but they are still being tested.

   PRICING...