Regulatory Landscape In Europe: Key Advice For Meeting Post-Brexit Qualified Person Requirements

By Harry Berlanga, Senior Director, Quality, EMEA, Thermo Fisher Scientific

Above and beyond COVID-related disruptions, the United Kingdom’s (UK) departure from the European Union (EU) has added a layer of complexity to the clinical trial supply chain in Europe. As of January 2021, the EU and UK function as separate legal and regulatory jurisdictions, and drug products must meet the relevant requirements for the market in which they will be sold.

While the UK’s Trade and Cooperation Agreement with the EU does provide for the mutual recognition of good manufacturing practice (GMP) inspections of drug product manufacturing facilities, the agreement does not stipulate mutual recognition for Qualified Person (QP) release or for product batch testing. However, in the UK, batch testing and QP certification is accepted as long as it is conducted in an approved country, currently the European Economic Area (EEA).

Beginning in January 2022, a full UK QP oversight process will be required for any investigational medicinal product crossing from an approved country into Great Britain clinical sites. Because UK-based QPs can no longer certify clinical trial batches for the EEA, companies using UK-based QPs must make substantive changes to established processes to continue to market their products in the EEA.

Thermo Fisher’s Harry Berlanga, Senior Director of Quality, EMEA, offers key advice for fulfilling QP requirements and minimizing supply chain risk and clinical trial disruption under the new rules.