MEXICO Law and Practice Contributed by: Adriana Ibarra, Carla Calderón, Marina Hurtado Cruz and José Hoyos-Robles, Baker McKenzie
and patients to monitor adverse events or inci- dents, and to investigate and report them. It is also necessary to have a pharmacovigilance or technovigilance unit, someone responsible for pharmacovigilance and someone responsible for technovigilance, and a pharmacovigilance or technovigilance manual. However, Phase IV data is only required for more complex products (eg, complex biologics or bio- tech drugs), as decided by the New Molecules Committee. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices COFEPRIS has periodically published lists of applications and lists of granted or rejected MAs. However, these lists are not updated regularly, and frequently contain limited information that excludes confidential information. Full access to individual files is only granted to the applicant. Although third parties have long been able to file public information requests in relation to any file held by COFEPRIS under the mechanisms overseen by the National Institute for Access to Public Information and Data Protection ( Insti- tuto Nacional de Transparencia, Acceso a la Información y Protección de Datos Personales INAI), COFEPRIS historically resisted provid- ing access to most of the files of MAs, which it regarded as being confidential in their entirety. Nevertheless, through several INAI decisions, an increasing number of data elements can now be accessed. Fortunately, COFEPRIS has now begun to populate a public database on its web- site that displays key data contained in the MAs for pharmaceuticals. Confidential information is protected by several special laws, including those related to privacy,
IP and administrative procedures, and labour and criminal law.
4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes Mexico’s regulatory framework for medicines and medical devices includes fast-track registra- tion through agreements with 42 global regula- tory agencies via the equivalencies registration route. Mexico signed its first equivalency agreements with Australia, Canada, Switzerland, the Euro- pean Union and the United States on 10 March 2012. On 29 March 2019, the agreements were expanded to include medicines and vaccines prequalified by the World Health Organiza- tion, covering Argentina, Brazil, Canada, Chile, Colombia, Cuba and the United States. During the COVID-19 pandemic in 2020 and 2021, the equivalencies registration route was expanded to ensure a stable local supply of medical products. This third expansion acknowl- edged members of the Pharmaceutical Inspec- tion Cooperation Scheme (PIC/S) and countries with products prequalified by the World Health Organization. Thus, the equivalencies registration route estab- lished a 60-business day (three-month) fast-track period, as opposed to the traditional registration route applicable to local medical products and subject to a 240-calendar day (eight months) period for COFEPRIS to issue a resolution on MA applications. The three waves of equivalency decrees are mostly similar, with minor differences. The
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