When it comes to conducting clinical studies in EU and UK, one of the critical steps is obtaining Qualified Person (QP) certification. QPs play a crucial role in ensuring the quality and compliance of medicinal products, including their manufacturing, testing, and release. However, with the United Kingdom’s departure from the European Union, there has been an additional regulatory challenge for companies conducting clinical studies in both regions. Separate QP certifications are now required for the EU and the UK, which can be time-consuming and costly.
QP Certification in Europe
Qualified Person certification is a legal requirement in EU and UK for the release of medicinal products to the clinical site. QPs are responsible for ensuring that each batch of a medicinal product has been manufactured and tested in compliance with regulatory standards, including Good Manufacturing Practice (GMP) guidelines. They provide an independent assessment of the quality and safety of the product, ensuring that it meets the necessary specifications before it can be released for use by patients/study participants.
The Impact of Brexit
With the UK’s departure from the EU, there has been a divergence in regulatory frameworks between the two regions. As a result, companies conducting clinical studies in both the EU and the UK now face the challenge of obtaining separate QP certifications for each jurisdiction. This requirement can significantly increase the complexity and costs associated with the certification process, as different QPs may need to be involved in the review and approval of each batch.
The PNR Approach
At PNR, we recognized the need for a more efficient and cost-effective approach to QP certification for clinical studies conducted in both the EU and the UK. To address this challenge, our QPs are listed on both our EU and UK licenses. This approach allows us to leverage the expertise of a single QP for batch reviews and certifications in both regions, eliminating the need for additional resources and multiple QPs.
Benefits of the streamlined approach:
- Time-saving: By utilizing the same QP for both the EU and the UK, PNR significantly reduces the time required for batch reviews and certifications. This streamlined approach eliminates the coordination and potential delays associated with engaging separate QPs in each jurisdiction.
- Cost-efficiency: The use of a single QP across the EU and the UK licenses helps minimize costs associated with certification. Companies can avoid the expense of hiring additional QPs to perform the QP oversight process* , reducing the overall financial burden of conducting clinical studies in both regions.
- Consistency and expertise: PNR’s QPs possess extensive knowledge and experience in both EU and UK regulatory requirements. This ensures a consistent and high level of expertise throughout the certification process, mitigating the risk of misunderstandings or discrepancies between the two jurisdictions.
- Regulatory compliance: By employing QPs familiar with both EU and UK regulations, PNR ensures that all batches undergo thorough scrutiny and meet the necessary standards for release. This facilitates compliance with relevant regulations in both regions, maintaining the integrity of the clinical study process.
This approach underscores PNR’s commitment to providing efficient and compliant services, ultimately benefiting the advancement of clinical research in Europe.
*UK QP oversight process – verification by a QP named on a UK MIA(IMP) that imported IMPs have been QP certified in a country on the ‘approved country for import’ list (initially, all EU and EEA countries) before release to the trial.