The European Medicines Agency (EMA) has adopted a guideline on the quality information that manufacturers of combination products should submit in marketing authorization applications. This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy of a medicinal product and outlines where this information should be placed in the Common Technical Document. The guideline should be read in conjunction with the Q&A on the implementation of the MDR.
_{July 27, 2021}

Medical Device Coordination Group Document (MDCG) published a guidance note integration providing recommendations on how the UDI can be integrated within a medical device organisation’s quality management system in order to meet requirements of the Medical Device Regulation (MDR) and in Vitro Diagnostics Regulation (IVDR).
_{July 20, 2021}

IMPs imported into Great Britain from a country on the ‘approved country for import’ list that have been QP certified in a country on the list will not require recertification in Great Britain. From 1 January 2022 a UK Manufacturing and Import Authorisation (MIA(IMP)) will be required to verify that these IMPs have been certified by a QP in a listed country (the ‘oversight process’). The new guidance describes what existing authorisation holders and new applicants should do to put procedures in place for the oversight process and how to apply for the required authorisation.
_{July 13, 2021}

Interruptions to the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM) due to travel restrictions (necessary by the COVID-19 pandemic) led to the creation of a system of Real-Time Remote Inspections (RTEMIS). The pilot project combines a live video feed, linking inspectors and manufacturing sites of active pharmaceutical ingredients (APIs), and the review of documentary sources. The objective is to monitor compliance with both Good Manufacturing Practice (GMP) and applications for certificates of suitability for European Pharmacopoeia (CEP) monographs at production sites. _{July 8, 2021}

EMA released version 2.1 of the EU IDMP Implementation Guide (EU IG v2.1) in June 2021. It provides standardised definitions for the identification and description of medicinal products for human use. The new version supports the implementation of Product Management Service (PMS) Step 1 and data submission on medicinal products authorised under the centralised procedure.
_{July 5, 2021}

The PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) has entered into force on 1 July 2021. The guidance has been developed primarily for inspectors, but also serves as a valuable resource for industry to provide clarity on areas of greatest risk and regulatory expectations. It marks the completion of significant effort by PIC/S Participating Authorities over an extended period of collaboration to address an area of significant industry and regulatory interest. The feedback received by professional associations across the pharmaceutical industry was highly valuable in identifying opportunities to further clarify regulatory interpretations and also collate topics for future revisions.
_{July 5, 2021}