Streamlining Clinical Trial Phases in the EU & Export Release

MIA Holder Assistance:

The Manufacturer’s /Importation Authorisation (MIA) holder provides essential support to Sponsors/Clients conducting clinical trials across all phases (1, 2, 3, and 4) in the EU and internationally. Here’s how they assist at each phase:

MIAS Sponsor/Clients Support

• Regulatory Submissions: MIAS assists with Investigational Medicinal Product Dossier (IMPD) submissions by providing Qualified Person (QP) declarations as needed for regulatory authorities, including variation submissions to list sites on the IMP Manufacturing and Importation (MIA) licence.
• Site Management: MIAS supports the qualification of clinical trial sites by conducting audits of drug substance, drug product and testing sites as requested by the Sponsor/Client.
• QP Declarations: MIAS issues QP declarations for drug substance, drug product manufacturing and testing sites located outside the EU/EEA.
• QTAs and QP Agreements: MIAS aids in establishing and reviewing Quality Technical Agreements (QTAs) and QP agreements when another QP in the supply chain provides partial manufacturing confirmation.
• Batch Record Review and QP Certification: MIAS conducts comprehensive reviews of trial batch records to ensure consistency with trial authorisations. We assist Sponsors/ Clients in maintaining document consistency and meeting batch release timelines to ensure timely patient dosages.
• Risk Assessments: MIAS performs risk assessments across the supply chain, product, and study trial to identify and communicate any risks associated with trial releases, implementing mitigation strategies as necessary.
• Quality Oversight and PQS Data Review: MIAS provides quality oversight of drug substances, products, and testing sites to ensure compliance. This includes reviewing audit reports, QTAs, deviation investigations, Out of Specification (OOS) results, and complaints. Any issues identified are communicated to the Sponsor/Client for corrective and preventive action (CAPA).
• Routine Engagement and Collaboration: MIAS regularly engages with Clients/Sponsors to address trial releases, changes in manufacturing or testing sites, and significant issues in advance to meet trial release timelines.
• Comprehensive Regulatory Document Review: MIAS reviews clinical trial authorisation documents for each EU territory as part of the IMP batch certification. We document any changes throughout the study, including the study protocol, trial authorisation, and country-specific regulatory documents etc.
• Stakeholder Engagement: MIAS facilitates communication with healthcare professionals and regulatory bodies to enhance trial visibility and support.

Global Assistance

• International Regulatory Compliance: MIAS supports sponsors in understanding and complying with regulatory requirements in different countries, ensuring smooth trial operations.
• Documentation for Exports: MIAS prepares the necessary release documentation for products intended for export, ensuring compliance with EU guidelines and local regulatory requirements.
• Site of importation: MIAS ensures that all requirements are met for clinical trial products regarding importation activities in compliance with EU guidelines.
• Market Authorisation Preparation: MIAS assists in compiling the necessary documentation for the Marketing Authorisation Application (MAA) based on trial findings.

Summary

The MIA holder serves as a vital partner for Sponsors /Clients throughout the clinical trial process, offering regulatory expertise, data management support, and strategic guidance to ensure successful trial execution and market authorisation in the EU and beyond. MIAS provides a comprehensive solution for all trial phases, including providing support for the Marketing Authorisation Application (MAA) for commercial product approval.