Comparison of post approval changes & requirements of US, Brazil & Mexico

Abstract

Once the medicine’s regulatory authority (RA) in a given country has approved its commercialization, the manufacturer or market authorization holder (MAH) may recognize the need for adaption to a registered dossier and make similar suggestions. If the expected modifications are thought to affect the medicine’s quality, safety and efficacity, the responsible RA must provide their previous authorization. These modifications may take the form of administrative or chemical manufacturing and controls (CMC) tweaks. Through the submission of an operation known as a "post approval change submission," these variations are communicated to the relevant authority for review of the suggested changes. A change is described as "A modification in every aspect of a medicinal product. In that 3 countries classification of PAC based upon risk.  In USA, the Food and Drug Administration (FDA) provide four reporting categories for post-approval adjustments are provided under Section 506 A of the Federal Food, Drugs, and Cosmetic Act and 21 CFR 314.70. In Brazil, National Health Surveillance Agency ‐ ANVISA provide Resolution (RDC73/2016) for filing guidance of post approval change. In Mexico, Mexican health authority or COFEPRIS provide criteria to define the classification of modifications to the conditions of sanitary registry of medicines. In conclusion, USA well define and specific guideline for various type of change compare to Brazil and Mexico. While there are similarities in the post-approval filing categories between the USA, Brazil and Mexico, there are also differences in terminology, processes, timeline for approval and specific requirements. Understanding these similarities and differences is essential for companies seeking to market regulated products in 3 countries to ensure compliance with regulatory requirements and facilitate timely approvals. These timelines can vary based on the complexity of the submission and the type of product.