Regulatory Frameworks for Obtaining and Renewing Marketing Authorisations of Generic Paracetamol 500 mg Tablets Imported from the United States: A Comparative Analysis of HPRA (Ireland) and AGEMED (Bolivia) in 2024, Using Paracetamol as an Illustrative Example.

Abstract

This study compared how two national agencies, HPRA in Ireland and AGEMED in Bolivia, approve and renew the marketing authorisations of generic paracetamol 500 mg tablets imported from the United States. The research aimed to identify the main differences in legal requirements, timelines, safety measures, and documentation, in order to recommend ways to improve regulatory efficiency and public access to quality medicines in Bolivia. A mixed-methods approach was used. First, legal and regulatory documents were reviewed. Then, an online survey was conducted with pharmaceutical professionals in Bolivia to collect both quantitative data (such as timelines) and qualitative insights (such as personal experiences and challenges). The focus was on real-life practices, especially for the approval and renewal processes. The results showed that Ireland’s regulatory process is more structured, digital, and aligned with international standards. HPRA requires bioequivalence studies, digital submissions, and ongoing safety monitoring. In contrast, AGEMED in Bolivia uses paper-based systems, does not require bioequivalence for generics, and often has slower timelines due to manual procedures. Survey participants highlighted delays, lack of clarity, and the need for system updates. In conclusion, the study found that Bolivia could improve its regulatory framework by adopting digital tools, requiring bioequivalence studies for generic medicines, and updating outdated legal guidelines. These changes could help make the approval process faster, safer, and more transparent. By learning from Ireland’s experience, Bolivia has the opportunity to modernise its system and improve public health outcomes.