Costa Rica Moves Forward In Consolidating An Efficient Regulatory System To Ensure The Quality Of Medicines And Health Technologies

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With the recent entry into force of a reform to the organic regulations of the Ministry of Health (MS), the Directorate for the Regulation of Products of Health Interest and Risk (DRPIRS) now has a revamped organizational structure, more specialized staff, and clarity in the functions of each of its units.

This is a firm step toward consolidating a national regulatory system that ensures that products of health interest are safe for the entire population. This category includes drugs, medical devices and equipment, hygiene products, food, cosmetics, pesticides, and chemicals.

According to the amended Article 29, the DRPIR must guarantee the quality, safety, efficacy, and harmlessness of health-related products that directly affect people's health. In addition, it is responsible for controlling related establishments by enacting rigorous regulations and promoting a favorable environment for the industry.

It also indicates that the DRPIRS, created in 2017, will henceforth be made up of the following organizational units:

Registration and Marketing Authorization Unit: empowered to manage and supervise registration and marketing authorization processes.

. Standardization Unit: responsible for establishing and updating regulations related to manufacturing, importation, storage, labeling, promotion, transportation, sale, and use.

. Surveillance and Control Unit: responsible for ensuring compliance with the regulations issued.

This great achievement is the result of the country's commitment and strategic actions to strengthen the DRPIRS as the national regulatory authority.

Joint effort

For many years, the Pan American Health Organization (PAHO/WHO) has provided technical assistance to the DRPIS in addressing issues related to governance, human resources, budgeting, competencies, and procedures, among others. It has also participated in assisted self-assessments using the World Health Organization's Global Benchmarking Tool (GBT) to measure its performance, identify gaps and opportunities for improvement, and define its level of maturity.

“PAHO has been our guide, showing us the way to strengthen our functions and become a level 2-3 regulatory authority, that is, stable, functional, and reliable. Most immediately, PAHO helped us shape the new structure that the Directorate has today and is supporting us throughout the transition process. In addition, we are conducting a risk analysis for the implementation of the 2026 Institutional Development Plan,” said Dr. Ignacio Calderón, Director of DRPIRS.

“We recognize Costa Rica for all its actions to strengthen the Directorate for the Regulation of Products of Interest and Health Risk, since national regulatory systems play a key role in public health, the right to universal health, and the economic development of countries. As an organization, we are fully prepared to continue supporting the authorities in accordance with their priorities and decisions,” emphasized Dr. Alfonso Tenorio, PAHO/WHO Representative in Costa Rica.

Since the Pan American Network for the Harmonization of Pharmaceutical Regulation (PARF Network) was established in 1998, PAHO/WHO Member States have been working together to support the convergence and harmonization of regulatory practices.

National regulatory authorities are responsible for ensuring that all people have access to safe, effective, and quality-assured medicines, vaccines, medical devices, and blood products.

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Its responsibilities:

. Authorize the marketing of products.

. Provide accurate information to those who will use medicines, vaccines, or any other health product so that their use is informed.

. Monitor drugs once they are on the market to determine whether they have adverse or harmful effects and recommend appropriate actions.

. Inspecting manufacturing practices and laboratory tests.

. Regulating clinical trials.

. Combating the counterfeiting of medicines.

The post Costa Rica Moves Forward In Consolidating An Efficient Regulatory System To Ensure The Quality Of Medicines And Health Technologies appeared first on The Costa Rica News.

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