In Mexico, the authority in charge of protection against health risks is COFEPRIS (Federal Commission for the Protection against Health Risks), created by decree on July 5, 2001, which is a public body decentralized from the Ministry of Health, whose mission is to protect the population against health risks caused by the use and consumption of goods and services, health supplies, as well as their exposure to environmental and work factors, COFEPRIS also attends the occurrence of health emergencies as well as the provision of health services through the regulation, control and prevention of health risks.
In this context, COFEPRIS must establish and implement policies, programs and projects at the level of international best practice, in effective coordination with the different actors in the public, private and social spheres, to prevent and address health risks, thus contributing to the health of the population. It should be noted that the Mexican regulatory agency is a world reference in terms of health regulation, since it always tries to go hand in hand with global policies dictated by international regulatory bodies. During this year, COFEPRIS has provided users of the regulatory system with different tools that allow them to carry out procedures efficiently and therefore quickly obtain their registrations, notices, licenses, etc. Among the new tools, the following stand out:
DIGIPRIS: Registration of New Medicines: Although the DIGIPRIS digital platform was launched in 2022 with the aim of meeting the need for people-centered, agile, fair and transparent regulation, at first only self-managed procedures such as operating notices, notices from health officials and advertising notices were included. Over the years, it has been improved to incorporate a greater number of procedures. Thus, in September of this year, the registration of new medicines was launched through DIGIPRIS, which will allow the pharmaceutical industry to enter applications to obtain authorizations for these health supplies, providing security in data protection and information management. In turn, DIGIPRIS Registration of new medicines allows applicants to review the progress of the evaluation of their procedure in real time without any acts of corruption involved. Another advantage is that digitalization allows reliance between regulatory agencies, thus optimizing regulatory processes.
Modifications to the conditions of sanitary registration of digital medicines: As of September 23, 2024, changes to health registration conditions can be entered 100% digitally. These modifications include minor and major changes to the health registration. In the case of minor or moderate changes, proof of changes to the health registration conditions is received immediately, while for major changes, an evaluation will be carried out and the updated health registration letter will be obtained. This space allows the process of registering changes to the health registration conditions to be more efficient for applicants.
VigiRam App: In an attempt to encourage consumers and healthcare professionals to report adverse reactions, COFEPRIS launched a new app called VigiRam in July of this year. This app features a user-friendly interface for reporting adverse reactions, since most of the time reporters gave up on this process because in the past it was complex and cumbersome. VigiRam is an app that is installed on a cell phone and comes preloaded electronically with the complete standardized format for reporting suspected adverse drug reactions. Notifications sent via this medium are transmitted in an encrypted manner directly to the National Pharmacovigilance Center. VigiRam allows for the capture of data/information without the need for an internet connection and does not require prior registration by the user to send the notification information. Other advantages of VigiRam are that it allows a notification to be sent with the minimum necessary information and that once the notification is sent, the application notifies that the information has been sent successfully and acknowledges receipt. This new mechanism for sending adverse reactions is a more user-friendly tool in relation to the tools that COFEPRIS previously had, such as telephone calls or emails, which result in excessive time consumption and little reliability for the people who are reporting the adverse reaction. The objective of VigiRam is to encourage drug consumers to report adverse drug reactions in order to have a safe health system.
Guide to obtaining the health control card for tattoo artists, micropigmenters and piercers: In April, COFEPRIS presented the Guide for obtaining the health control card for tattoo artists, micropigmenters and piercers. This guide aims to properly guide people interested in obtaining the health control card, which is a mandatory requirement to perform tattoos, micropigmentation and piercings in national territory. With a focus on risk prevention and compliance with health regulations, this guide establishes a series of requirements that those interested in obtaining the health control card must meet. Tattoo artists, piercers and micropigmenters must prove their training and knowledge of techniques and procedures in order to comply with current health regulations and prevent risks to the health of the population. The guide also includes the procedure manuals and certificates that must be presented, the way in which fees must be paid, prevention points, additional legal and technical documentation, the health conditions to be met and the infrastructure that establishments where this type of work is performed must have. With the implementation of this guide, COFEPRIS seeks to raise the quality and safety standards in the tattoo, micropigmentation and body piercing industry in Mexico, since these aesthetic procedures are increasingly common among the young population, in addition to the fact that non-compliance with health regulations not only leads to the closure of the establishment, but also fines and damages to third parties must be covered.
Roles and Responsibilities Guide for Influencer Advertising (Grrupi): This guide was published by COFEPRIS as a tool to regulate advertising involving influencers in Mexico and its main objective is to clarify the responsibilities of all the actors involved in the advertising chain: advertising brands, advertising agencies, influencers and the media. Grrupi arrives in a context where advertising has grown exponentially, but until now the regulation of influencers in Mexico has been limited to what is established in Article 32 of the Federal Consumer Protection Law and a guide previously published by the Federal Consumer Protection Agency (PROFECO). The guide clearly describes each of the roles and responsibilities of the actors in the advertising chain, as well as what influencers must do when generating advertising for food supplements, health products and services, food and alcoholic beverages and tobacco. It also includes tips to consider before accepting an advertising collaboration that allow determining whether the advertising they create represents a risk to the health of the population. Another point included in this guide is a brief glossary of terms related to this type of advertising. COFEPRIS considers Grrupi to be a fundamental tool for protecting public health and guaranteeing ethical and responsible advertising practices, thus contributing to generating quality products and services, with safe and reliable information on the well-being of the community.
Complete and detailed information on each of these tools is available on the COFEPRIS portal, where you can consult, for example for DIGIPRIS registration of new medicines: manuals, characteristics that the dossier must meet in digital format, tutorials, frequently asked questions, among others. It should be noted that to carry out procedures on the COFEPRIS digital platforms, it is necessary to have a valid e-signature. With the use of these important tools, bureaucracy in procedures is reduced, making the processes faster and more accessible and minimizing errors and costs associated with paper procedures.
To ensure the safety, quality and efficacy of health supplies, it is necessary to have solid health regulations and in this sense Mexico has a regulatory agency that has complete regulatory capacities such as the evaluation and authorization of medicines, vaccines, medical devices and other health products, the implementation of effective health surveillance systems and compliance with international standards in its regulatory processes and decisions, which is why these new tools contribute to achieving these objectives but, above all, to guaranteeing the health of the population.
Sources:
Comisión Federal para la Protección contra Riesgos Sanitarios (2024)
https://www.google.com/search?client=firefox-b-d&q=cofepris
RAF Consulting Vigiram (2024) https://rafconsulting.net/blog/tag/vigiram/
Plataforma de trámites y servicios de la COFEPRIS (2024)
https://www.gob.mx/cofepris/acciones-y-programas/digipris?state=published
