After successful clinical trials, new medicines or treatments need to be licensed and approved before they can be made available to patients. Our team works hard to ensure medicines gain and maintain the market or regional regulatory authorisations they need to ensure patients have access to the portfolio of Pfizer medicines and vaccines.
To ensure that medicine approvals are managed efficiently, our policy team monitors how the regulatory environment is changing and how this might impact the regulatory framework in different markets. We work with organisations such as The European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), as well as local trade associations, to identify potential barriers and help shape the system for innovative treatments, such as gene therapy.
In addition to licensing and registration, our wider team is also responsible for ensuring that information about each medicine or vaccine, for both patients and healthcare professionals, is kept up-to-date. To help manage this labour-intense and complex task, which includes updating ~26,0001 artwork components each year, Pfizer is investigating how machine learning, automation and artificial intelligence capabilities might be developed to streamline our processes, reduce cycle times and improve patient knowledge about their medicines.