GMP Inspections and the Provision of Batch Records in Sub-Saharan Africa

Position paper 1 Mar 2023

Fee system for regional joint assessment procedures in Africa

This joint position paper covers the perspective from industry on the proposed fee system for regional joint assessment procedures in Africa.

Pharmacy-mediated substitution for biosimilars

This position paper from IFPMA addresses substitution relating to biosimilars and their reference products at the retail pharmacy level. While this practice has been in place in many countries for generics, for biosimilars, the practice is only emerging.

Convergence and reliance approaches for advanced therapy medicinal products

Cell, tissue and gene therapies offer significant potential to treat diseases with high unmet medical needs, and consist of human cell and tissue products for medical use and advanced therapy medicinal products (ATMPs). IFPMA shares points to consider when promoting regulatory convergence and reliance approaches for ATMPs.