Pharmaceutical regulations in Uruguay and Paraguay: recent regulatory changes, trends and challenges

Viviana Cervieri
Cervieri Monsuárez, Montevideo
vivianacervieri@cmlawyers.com.uy

Jesús Urbina
Cervieri Monsuárez, Montevideo
jurbina@cmlawyers.com.uy

Lucía Arimón
Cervieri Monsuárez, Asunción
larimon@cmlawyers.com.py

Romina González
Cervieri Monsuárez, Asunción
regulatoriopy@cmawyers.com.py

Introduction

Pharmaceutical regulations in Southern Common Market (Mercado Común del Sur or MERCOSUR) member countries, such as Uruguay and Paraguay, have undergone key transformations in recent years. These changes have been driven by the need to improve access to medicines, strengthen regional and international trade and modernise regulatory systems. However, there are still challenges, such as the disparity in approval processes and the lack of harmonisation between the countries’ regulatory systems, which has limited the competitiveness and agility of pharmaceutical trade. To address these obstacles, the regulatory authorities have adopted measures aimed at aligning their regulatory frameworks with international standards and promoting cooperation between countries.

Regulatory framework and recent changes

In Uruguay, a significant step has been taken towards the modernisation of its regulatory system with the adoption of the common technical document (CTD) format for medicine registration applications, effective as of October 2024. This model, widely used internationally, enables the harmonisation of regulatory processes and enhances the efficiency of pharmaceutical product evaluations. The regulatory authority, the Ministry of Public Health (Ministerio de Salud Pública or MSP), has implemented specific guidelines for the structuring and submission of documentation pursuant to the CTD, through a communication issued in April 2024 to regulate Article 6 of Decree No. 018/020. This aligns with global best practices and promotes regional integration in the regulatory field. This measure not only optimises the file review process and reduces the paperwork burden for companies, but also strengthens transparency and predictability in regard to the approval process, helping to establish Uruguay as a regional leader in terms of regulatory modernisation.

As for Paraguay, the last few months have been marked by several regulatory updates, including regulatory decrees and resolutions issued by the National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria or DINAVISA), the current enforcement authority in regard to pharmaceutical matters. Since the enactment of Law No. 6788/2021, several amendments have been implemented to modernise the regulatory system, optimise the evaluation processes and reinforce the quality and safety standards for pharmaceutical products. One of the major steps forward has been the adoption and strengthening of the reliance model through the implementation of Resolution No. 148/2024, which establishes reference regulatory agencies.^[1] In addition, Resolution No. 147/2024 has approved a best practices manual for utilising the regulatory decisions made by other authorities in regard to the regulation of medicines, vaccines, blood and blood derivatives, medical devices and in vitro diagnostic products.^[2]

The main purpose of these regulations is to provide guidelines for the implementation of the reliance model, strengthening accessibility and responsiveness within the regulatory framework, particularly in regard to managing public health emergencies, handling new technologies and practices and promoting international regulatory cooperation.

A key development introduced in 2024 in Paraguay is the removal of the requirement for apostille or legalisation by the Ministry of Foreign Affairs for foreign official documents that can be verified through official links or quick response (QR) codes. This measure simplifies the paperwork requirements and reduces the costs for companies that decide to invest in Paraguay. In addition, a simplified renewal procedure has been established for products that do not require bioequivalence studies, in which no modifications are allowed during the renewal of the registration, guaranteeing the stability of the information previously approved and optimising the regulatory management process.

Additionally, as part of the efforts by the Paraguayan authorities to update the relevant regulatory frameworks, recent regulations on pharmaceutical specialties (Resolution No. 277/2024),^[3] biological medicines (Resolution No. 233/2024)^[4] and herbal medicines (Resolution No. 89/2025)^[5] are pertinent. These regulations update the requirements for registration applications and renewals, aiming to centralise the existing provisions in each area.

In addition to this, the DINAVISA is currently evaluating regulatory projects related to important issues such as the exceptional authorisation of unregistered or unavailable medicines in the country and the temporary authorisation of medicines that lack sanitary registration in emergency situations. These regulations would allow the importation of unregistered medicines pursuant to exceptional procedures, ensuring access to safe medicines as a result of the DINAVISA’s oversight. Official regulations are expected to be issued in regard to both scenarios later this year.

The impact on the industry and pending challenges

The impact of effective health surveillance management in countries such as Uruguay and Paraguay could be promising, as it would strengthen the control capabilities and the efficiency of their health systems. Effective regulation not only optimises the response to health emergencies, but also enhances the safety of pharmaceutical products in the market. This could foster greater cooperation and trust among MERCOSUR member countries, promoting a safer and better regulated pharmaceutical market. Regulatory harmonisation, by reducing trade barriers and enabling interoperability between regulatory systems, facilitates the flow of health products between countries, ensuring that companies can operate more efficiently. Moreover, by ensuring high-quality standards, citizens in these countries benefit from better access to medicines and treatments, contributing to their constitutional right to health.

It is worth noting that as early as 2013, the South American Institute of Government in Health (ISAGS) of the Union of South American Nations (UNASUR) emphasised the urgent need to improve the regulatory infrastructure in Paraguay and Uruguay. In the Health Surveillance Report,^[6] published in October 2013, the importance of strengthening health systems from an epidemiological, health and environmental perspective was emphasised in order to address the growing challenges in the context of disease control and pharmaceutical product safety. This report, issued more than a decade ago, identified deficiencies in the respective infrastructure and the need to strengthen health surveillance. Despite some progress, these issues remain relevant today and affect the effectiveness of the regulatory system, with a clear need for improvements and harmonisation.

Although efforts have been made by key actors in Paraguay, such as the DINAVISA, to modernise and strengthen the regulatory system, technical support was requested from the Pan American Health Organization (PAHO)^[7]/World Health Organization (WHO) in 2023 to improve certain strategic areas. This process included the delivery of workshops, during which over 300 technicians from the public, private, academic and laboratory sectors were trained. As the result of an assisted self-assessment by the country, the creation of an institutional development plan (PDI) is expected, aiming to achieve certification as a national regulatory authority (NRA) at maturity level 3, which would ensure a more stable regulatory system. Although this recognition has not yet been achieved, significant progress has been made, generating positive expectations. It is essential that Paraguay remains vigilant and continues to modernise its health surveillance system to consolidate these advances and effectively address future challenges.

In turn, the MSP in Uruguay has implemented significant initiatives to strengthen the regulatory framework for medicines, ensuring their efficiency, safety and accessibility.^[8] These actions, aligned with international best practices, underscore the country’s commitment to public health. In 2023 and 2024, key improvements were made in areas such as disease control and prevention, as well as access to high-cost medicines. These amendments aim to expedite the provision of new drugs in the country and optimise the use of available resources.

Additionally, the MSP has strengthened its Pharmacovigilance Unit through the implementation of innovative digital tools, such as the e-reporting industry platform.^[9] This system facilitates the reporting and monitoring of adverse drug reactions, ensuring the continuous evaluation of drug safety. Furthermore, the relevant regulations and protocols have been updated to ensure compliance with international pharmacovigilance standards.

Moreover, as part of a priority reform initiated in 2020, the MSP has promoted the creation of the Uruguay Health Technology Assessment Agency (La Agencia de Evaluación de Tecnologías Sanitarias de Uruguay or AETSU).^[10] This agency aims to analyse applicable technologies and guide the regulatory processes related to the authorisation and registration of medicines, thereby strengthening the control mechanisms for drugs and other health-related technologies. Although the inclusion of this agency in the country’s regulatory system is still subject to an implementation process, it currently only provides technical reports on issues related to the health sector.

Conclusion

Regulatory advancements in Uruguay and Paraguay demonstrate both countries’ commitment to improving the efficiency and transparency of their regulatory systems. However, key challenges remain, such as improving regulatory infrastructure and consolidating international cooperation, to ensure a more efficient and accessible regulatory system that aligns with global best practices and facilitates access to medicines.

Notes