EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information

Yesterday (14 July 2023) the European Medicines Agency released an updated regulatory and procedural guideline "Compilation of Union procedures on Inspections and Exchange of Information" to maintain uniformity and streamline procedures that EMA A has published.

The Compilation of Union Procedures on Inspections and Exchange of Information facilitates aims to facilitate cooperation among national competent authorities (NCAs) and the EMA, ensuring consistent enforcement and harmonized practices across member states.

A national GMP inspectorate's quality system is based on the procedures found within the compilation, and there are two parts to it: procedures in Part I and other documents (such as interpretation documents and regulatory forms) in Part II.

There are several topics covered in the guidance, including the planning and conduct of inspections, reporting, and follow-up measures, which describe the inspection procedures followed by NCAs and the EMA. A risk-based approach to inspections and a harmonized practice are both stressed in the guidance in order to ensure consistency.

In addition to addressing information exchange among regulatory authorities, the guidance describes procedures for sharing inspection results, recommendations, and corrective and preventive actions (CAPAs), facilitating transparency, enhancing coordination, and improving decision-making regarding marketing authorizations and post-authorizations.

In order to maintain the integrity and reliability of medicinal products available on the European market, it promotes harmonisation efficient resource utilization, timely decision-making, and improved patient safety measures.

Click this LINK to know exclusive details on the various Part-I & Part-II procedures.