1Department of Pharma Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research (KBIPER), a constituent college of Kadi Sarva Vishwavidyalaya (KSV), Sector-23, Gandhinagar-382024, Gujarat, India
2Step up Pharmatech Regulatory Consultant NaranpuraAhmedabadGujaratIndia380013.
*Corresponding author. E-mail address: maitreyi.zaveri@kbiper.ac.in (M. Zaveri)
The regulatory registration and approval processes for semaglutide tablets 14 mg in Chile, Peru, and Bolivia—three developing South American markets—are compared in this paper. Regulatory bodies, dossier specifications, submission processes, review schedules, labelling requirements, and post-approval variances are all examined in the analysis. The results show that the three nations' technical documentation, GMP certification standards, language requirements, and approval procedures differ from one another. Bolivia retains a more administrative and mostly offline submission method, whereas Chile and Peru adhere to more structured regulatory frameworks with components that are in line with international norms. In order to facilitate effective market entrance planning and compliance in developing South American pharmaceutical markets, this comparison offers key regulatory insights.
The investigation reveals significant variation in Chile, Peru & Bolivia s Semaglutide market Regulatory Frameworks, particularly with regard to documentation, submission process & Compliance Bolivia has a more Manual Method Whereas Chile and Peru adhere to more Standarized, globally aligned systems. For an efficient registration Strategy and seamless market entry, these distinctions are essential.
Semaglutide Tablet 14 mg, Regulatory Approval Pathways, Pharmaceutical Registration, Emerging South American markets, Comparative Regulatory Analysis
