Delivering clinical supplies into the European Union and United Kingdom requires rigorous
oversight from a QP to ensure every batch meets regulatory, GMP, and trial-specific requirements. Yet, many
sponsors face preventable delays, often due to incomplete documentation, limited supply chain visibility, or
late communication of changes. This paper breaks down the core responsibilities of the QP, explains how
European Union and United Kingdom expectations differ, and share practical steps sponsors can take to
streamline the certification process. Readers will learn how to prepare audit-ready documentation, avoid
common pitfalls that extend release timelines, and build efficient collaborations with QPs to keep studies
moving without interruption.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.
The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
