Support to Regulatory Systems

Our Industry

The quality, safety and efficacy of medicines is of paramount importance to the pharmaceutical industry and is a priority area of work for FIFARMA and its members in Latin America and the Caribbean. 

To protect the health of patients, regulatory oversight by National Regulatory Authorities (NRAs) must enforce the highest quality standards and exercise effective surveillance of drugs and pharmaceuticals throughout their life cycle: from research and development, production, the sanitary approval process, to distribution, use and market surveillance. 

As a Federation, one of our tasks is to contribute to promote these high standards and good regulatory practices with a regional vision and an integral perspective to make decisive progress in health innovation, while protecting the life and health of patients. This is a joint vision that we build from the local level, in close collaboration with governments, NRAs and industry. 

Weak regulatory systems can be a barrier to access to safe, efficient, and quality medical products. (World Health Assembly Resolution 67.20 of 2014). Our proposal for all stakeholders in the healthcare ecosystem is the permanent search for new ways of thinking about healthcare from a regional perspective, where quality and safety standards for patients, regulatory agility and effectiveness, and the protection of intellectual property are our pillars. 

Good Regulatory Practices

FIFARMA supports the adoption of good regulatory practices as a tool to strengthen health systems in Latin America in order to achieve better health outcomes.

Area 1: Increasing transparency

Transparency is an essential principle for NRAs, patients, payers, the medical community, and industry. We promote transparency initiatives such as, for example, the publication of evaluation reports accompanying drug approvals. This increases stakeholder confidence in medicines and other regulated products. 

Area 2: Ensuring consistency in the application of regulatory guidelines

The principle of consistency in the development, implementation and enforcement of regulations is fundamental and is therefore also considered a good regulatory practice. FIFARMA supports the WHO recommendation that "New regulations should support and complement, and not conflict with, existing regulations". 

This harmonization between local and international regulation is possible if we strengthen international regulatory cooperation and facilitate exchange programs in this area. As a Federation, we are constantly seeking to build consensus and tools for compliance with the obligations deriving from international treaties and regional agreements. 

Area 3: Adopting technology to support good regulatory practices

Technology and digitalization provide new opportunities to implement mechanisms to facilitate and improve the activity of regulatory agencies. We promote and encourage the use of information and communications technologies to increase agility, transparency, and efficiency, as well as to improve reporting and public accountability by regulators and the pharmaceutical industry. 

Area 4: Supporting innovation driven by scientific progress

Good regulatory practice supports a degree of flexibility within the regulatory environment to ensure that the dynamics of emerging medical and scientific innovation are recognized, without ever compromising the efficacy, safety, and quality of medicines.

In addition, WHO guidelines state that regulatory oversight should not be prescriptive (or rigid), but should be flexible to respond to a constantly evolving environment and unforeseen circumstances, being prepared to provide timely responses to emergency situations, as in the case of the Covid-19 pandemic.

Related documents

FIFARMA Position Paper - Good Regulatory Practices: Enabling regulatory efficiencies for timely drug disposition in Latin America and the Caribbean