Impact Assessment of Divergence on Post-approval Changes Classifications of Latin America Region With Europe and the United States, and Propositions to Harmonize Classification Based on Risk as a Path to Build the Trust Between National Regulatory Agencies

ABSTRACT

The lack of harmonization in the post-approval changes (PACs) classifications for pharmaceutical products may have an impact on the efficient implementation of PACs and in the supply of medicine, jeopardizing the continuity of therapies, especially in the case of chronic diseases. The percentage of similarity between the PACs classifications existing between countries of Latin America (Mexico, Brazil, Colombia, Venezuela, Argentina, Chile, Ecuador, Peru, and Central America) versus Europe and the United States (US) has been calculated, focused on the PACs for chemical products and on the minor and moderate variations as defined in the European Union (EU)^1,2 and US³ regulations. Even though Mexico, Colombia, Brazil, and Argentina implemented a risk-based PACs classification, a wide diversity is observed, with a high percentage of variations classified as major or high risk for these countries and the rest of the Latin American countries, except for Venezuela (which previously adopted and recognized the EU classification). In addition, we identified a group/subset of PACs that are not categorized in the regulations of Mexico, Brazil, Chile, and Central America countries. Considering that Mexico, Brazil, and Argentina are members or observers of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use⁴ and the Pharmaceutical Inspection Co-operation Scheme,⁵ these countries could further align their PACs classification with the EU and US regulations. This could also be an opportunity for other countries of the Latin America region to recognize and adopt PACs classifications aligned to the EU or United States, which would also support the inclusion of reliance processes in their regulation for already considered/recognized reference countries. This would guarantee more health authority efficiency and optimization as well as more uniform implementation of PACs globally.