Regulatory landscape in Europe: Key advice for meeting post-Brexit Qualified Person requirements

10월 6, 2021 By Harry Berlanga (4 minute read)

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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 above and beyond COVID-related disruptions. 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. As has always been a requirement, QPs in the EEA must certify each batch of finished product before clinical trial or commercial release in the EEA. But, 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.

In a recent webinar discussing the implications of the changing regulatory landscape on QP services, Thermo Fisher’s Harry Berlanga, Senior Director of Quality, EMEA, and Alessandro Barbato, QP for drug substance, drug product, and steriles, offered the following key advice for fulfilling QP requirements and minimizing supply chain risk and clinical trial disruption under the new rules.

             

“It is imperative that pharmaceutical companies based outside of Europe really understand European GMP requirements and the role and responsibilities of the EU and UK QPs, by reviewing the supply chain quality agreements, and the QP-to-QP agreements and keeping them up to date,” Berlanga says. He also recommends partnering with a CDMO that has the technical and scientific knowledge to understand your molecule and project, deep regulatory experience to navigate the changing landscape, and in-house UK- and EU-based QPs to support drug product release and batch certification in both regions to mitigate Brexit-related risks for your clinical trial and commercialization.

More information on QP services can be found here.

Harry Berlanga

Senior Director, Quality, EMEA

A Chartered biologist, with a Masters in Pharmaceutical Sciences, Harry has over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Harry currently holds the position of Senior Director, Quality, EMEA, leading the EMEA Quality function across the Clinical Trials Division at Thermo Fisher Scientific. Based in Horsham, UK, Harry oversees 6 sites specializing in the Manufacture, Packaging and Distribution of Investigational Medicinal Products (IMPs). Harry previously led Quality at the Thermo Fisher Scientific Horsham site for several years. Harry is an experienced Qualified Person (QP) for clinical and commercial products.

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