The Regulatory Standardisation Challenge │ Mexico

The regulation of healthcare and life sciences is complex and constantly evolving as new technologies and treatments are constantly emerging, and it is the government's duty to guarantee that these advances are safe and that the general public is not exposed to any potential risks. Sanitary regulations are guidelines set by governments, health organisations and other regulatory bodies to ensure that public health is protected from health hazards and risks. These regulations cover a wide range of topics, from the pharmaceutical industry to food safety, as well as all products that can pose a risk to human health if they are not properly handled or processed.

The pharmaceutical industry is one of the most strictly regulated industries worldwide. Governments set laws, regulations and guidelines that govern the development, production, testing and distribution of pharmaceutical drugs and medical devices, and the main aim of these regulations is to ensure that the drugs used by the public are of high quality, safe and effective.

Medical devices are also subject to regulation. Regulatory agencies are entitled to oversee the registration and control of medical devices and pharmaceutical products (pharmacovigilance and technovigilance), to ensure that they meet established safety and performance standards.

In addition to pharmaceutical products and medical devices, clinical trials are also subject to regulation aimed at making sure that these trials are conducted in a safe and ethical manner, with appropriate controls in place to protect the rights and well-being of human research participants.

In the United States, the Food and Drug Administration (FDA) is the main health authority, whereas the European Medicines Agency (EMA) plays a similar role in the European Union.

In Mexico, the regulatory agency is the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) under the Mexican Ministry of Health, and it is responsible for ensuring the safety, efficacy and quality of pharmaceuticals, medical devices, food and other health products.

By evaluating and approving applications for marketing authorisations of health products, this decentralised body plays a crucial role in protecting the health and safety of the Mexican population. Pharmaceutical products intended for sale within the country must obtain a Sanitary Registration Certificate, confirming that a product has been evaluated and approved for sale and use in the country. Since regulatory requirements are constantly being updated, Sanitary Registrations are subject to periodical reviews every five years to keep them in full force and effect.

It is worth highlighting the relevance of government actions to develop harmonisation strategies, which provide applicants with an accurate understanding of the regulatory requirements of each country, their application by corresponding local bodies and the expected timelines for approval.

COFEPRIS is already a member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) looking to focus its efforts on harmonising criteria with other regulatory agencies abroad and establishing more efficient grounds to register products in different industries, mainly for companies engaged in pharmaceuticals.

Regulations are intended to protect homogenous rights and there are efforts to unify criteria and guidelines; however, sanitary and pharmaceutical regulations vary from country to country. Each jurisdiction has its own criteria for overseeing, regulating and enforcing sanitary regulation procedures. Thus, regulatory systems in certain countries may be more stringent than in others, leading to variation in the amount of time and resources needed to obtain regulatory approval.

These differences pose a challenge to companies seeking to register their products in multiple Latin American countries as they must go through various regulatory procedures and comply with different requirements, even though they are looking to protect the very same family of products.

It is therefore important to be aware of advances in the harmonisation of regulatory processes, such as the creation of the Ibero-American Network of Pharmaceutical Authorities (Red EAMI), which promotes collaboration and exchange of information among the regulatory agencies working through this network.

By managing portfolios for global brands, Vila Abogados has experienced challenges as products with identical formulas may be classified as either a medicine or a food supplement, depending on the country’s regulation. This variation can lead to differences in regulatory and approval processes. Moreover, each authority has sui generis capacities, staff and experience, with different standards and timeframes for classification, importation, circulation and sale of products.

Therefore, it is always advisable to align regulatory strategies with international guidelines, to help companies to find it less challenging to navigate through the regulatory terrain in Latin America, being better equipped to obtain necessary authorisations to introduce their products into the market.

Regulatory agencies are different from IP offices; therefore, it is not uncommon that the actions of one may contradict those of the other.

In addition, in many jurisdictions there is no legal framework to establish an official communication channel between such authorities to avoid potential legal hurdles and secure their interests, although these exist in some jurisdictions, such as the linkage system.

Therefore, it is important to bear in mind that the assistance of local legal experts is highly advisable to ensure the proper protection of intellectual property in each country where companies plan to introduce their products, from planning a course of action for registration of patents and trade marks and freedom to operate surveillance, to execution of monitoring policy to take timely legal action against potential infringements.

To develop an effective strategy of product standardisation in Latin America, companies must first conduct a complete analysis of the regulatory requirements in each country they wish to enter. This analysis should consider the differences in regulatory frameworks and timelines, as well as any potential barriers.

Companies must prioritise protecting their intellectual property and considering third party IP to avoid contingencies.

By taking proactive measures, global companies can comply with regulatory requirements and safeguard their competitive advantage to ensure long-term success in the Latin American market.