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Global Regulatory Affairs

The UK is one of Pfizer’s Global Regulatory Affairs hubs, where regulatory submissions, product licensing, clinical trial applications, translations, labelling and artwork for over 170 markets across the globe are managed.

 

After successful clinical trials, new medicines or treatments need to be licensed and approved before they can be made available to patients. Our team based primarily in Sandwich, Kent and Walton Oaks, Surrey, works hard to ensure medicines gain and maintain the market or regional regulatory authorisations they need to ensure patients have access to both our new and older, medically important, Pfizer medicines.

To ensure that medicine approvals are managed efficiently, our policy team monitors how the regulatory environment is changing and how this might impact drug approvals in different markets. In Europe, we work with The European Federation of Pharmaceutical Industries and Associations (EFPIA) to identify potential barriers with current legislation and help shape the system for new treatments, such as gene therapy and personalised medicine, to ensure medicine approvals can be even more efficient in the future.

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 hugely labour-intensive and complex task, which includes updating 14,000 product labels and 26,000 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.

 

PP-PFE-GBR-1701 / May 2019