Report 30 November 2018

Case Studies to Illustrate IFPMA Position Paper on the Handling of Post-Approval Changes to Marketing Authorizations


In the past few decades, the biopharmaceutical industry has contributed significantly to global health progress. Millions of people are benefiting from medical innovation and no one can contest today that people are living longer and healthier worldwide.

It is the intense innovation by biopharmaceutical companies from the discovery of vaccines, to the development of novel medicines to combat deadly infectious diseases, cancer, and other life-threatening diseases that have brought us where we are today and will take us where we need to go tomorrow in achieving better health for all. Yet, in some therapeutic areas and geographic settings, progress is slow and remains incomplete. This is why we propose to collectively join efforts and work towards achieving the Sustainable Development Goal 3, so that all can benefit from innovation in health.

This brochure describes the complexity with handling such regulatory activities, and the impact it has on access to such medicinal products. It is supported by six illustrative case studies aimed at raising awareness about the current challenges of PACs regulations and demonstrating how the consistent and predictable management of PACs can enhance public health overall. This represents an opportunity for all relevant stakeholders to partner and ensure patients’ timely access to innovative medicines.