Strengthening regulatory systems in the Americas region: lessons learned from National Regulatory Authorities
Last October, FIFARMA and ALAFARPE held an internal workshop called “Strengthening of Regulatory Systems: Learnings and experience of the regulatory authorities in Latin America” with the purpose of understanding the regulatory landscape in the region.
The activity was framed within the guidelines of the Organization for Economic Cooperation and Development (OECD) which, through its publication “Recommendation of the Council on regulatory policy and governance” (2012), address the regulatory policy, management and governance as an activity that every Government can and should work on through sectoral ministries, regulatory and relevant agencies. In this sense, the Pan American Health Organization (PAHO) took the recommendations as a model to apply them to the National Regulatory Authorities (ARN) of the health sector.
One of the government’s objectives for the next few years should be the institutional strengthening of our health authority. And thus, allow timely access to medicines that patients need, making visible the role, impact and importance that authorities have on patient’s waiting time. We make ourselves available to the government to establish public-private work groups to work together to strengthen the ARN.
PAHO / WHO have published in 2020 and 2021 the recommendations to strengthen regulatory systems based on Good Regulatory Practices (GRP), Good Reliance Practices (GRelP) and in the regulatory authorities assessment manual (GBT) to obtain their respective rating. Peru does not yet have a classification by the World Health Organization (WHO). For the United Nations (UN), having health systems that are not strengthened puts patients at risk.
Strengthening RNAs will allow patients to access effective, safe and high quality innovative medicines at the right time.
Written by ALAFARPE
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