Quality & Safety

FIFARMA is engaging with governments and regulatory bodies as well as with other actors involved in the development, manufacturing, registration, distribution and use of medicines to inform and educate about pharmacovigilance – formal drug safety surveillance, monitoring and reporting – as well as other relevant topics impacting quality, safety and efficacy of medicines in Latin America.

FIFARMA supports ongoing programs and initiatives to monitor the quality of medicines and patient safety in Latin America, among them:

Effective Regulatory Reliance

What is the importance of using regulatory decisions from other jurisdictions to support the strengthening of the Regulatory Agencies in our region? We invite you to learn about important considerations in the following documents that show how to obtain success using those decisions and continue to preserve and improve the lives of patients in Latin America.

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Considerations for effective regulatory reliance by Health Authorities in the Latin America Region Industry Perspective – Infographic

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Considerations for effective regulatory reliance by Health Authorities in the Latin America Region- Industry Perspective – Paper

COVID - 19

Learn about the pharmaceutical industry’s regulatory priorities to ensure the supply of medicines and vaccines during the pandemic throughout Latin America:

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COVID-19 – Infographic

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Regulatory Issues in the context of Health Emergencies – Paper

Advanced Therapies

These Advanced Therapies are continually breaking the limits of science and challenging the expectations of modern medicine. Learn about the 3 areas of opportunity in the following documents:

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Advanced Therapies – Infographic

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Advanced Therapies – Paper

Good Regulatory Practices

FIFARMA supports the adoption of Good Regulatory Practices as a tool to strengthen health systems in Latin America. Learn about the 4 key areas in the FIFARMA paper on Good Regulatory Practices:

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FIFARMA Position Paper – Good Regulatory Practices: enabling regulatory efficiencies to deliver medicines in a timely manner to Latin America and the Caribbean – Paper

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Good Regulatory Practices in the Pharmaceutical Industry – Infographic

Vigilantia

Vigilantia is a Latin American-focused educational initiative led by FIFARMA and its members with a mission to bring all health stakeholders together to improve the pharmacovigilance systems in the region. Learn more about the Vigilantia initiative in the video below. Also, click here to read an article about the initiative published in the Journal Pharmaceuticals, Policy and Law.

Fight The Fakes

In order to protect the life of the most vulnerable people in Latin America, the pharmaceutical industry is working on implementing a long-term plan to fight against the illicit market of medicines.
Fight the Fakes is an international campaign endorsed by FIFARMA that aims to raise awareness about the dangers of fake medicines. It seeks to build a global movement of organizations and individuals who will shine a light on the negative impact that fake medicines have on people around the globe and to reduce the negative consequences on individuals worldwide. For more information, please visit www.ﬁghtthefakes.org

You can learn more about FIFARMA’s efforts to promote quality and safety by reading the Vigilantia and Fight the Fakes reports and educational materials.