EMA: Annual Report of the GMDP IWG 2024

The EMA's GMDP Inspectors Working Group (GMPD IWG) has published its 2024 annual report.

Among other things, the report covers:

GMP and GDP Inspections
Despite the end of the COVID-19 public health emergency in May 2023, some pandemic-related restrictions continued to impact inspections. EU inspectorates made significant progress in 2024 to resolve the existing inspection backlog, particularly for sites in third countries. The automatic extension of EU GMP Certificates was not continued beyond the end of 2024.

Mutual Recognition Agreements (MRAs)

• USA: Continued work on including veterinary medicines in the MRA, with an agreed extension of assessment timelines in July 2024
• No changes were reported for MRAs with Japan, Canada, Switzerland, Australia, and New Zealand
• Support continued for EU Accession Countries, with observers from Albania, Bosnia and Herzegovina, and other countries attending meetings

Harmonisation Topics
Key harmonization efforts included:

• Joint Audit Programme: 15 on-site audits conducted
• Restructuring of the Compilation of Union Procedures in August 2024
• Ongoing work on updating annexes for veterinary medicinal products
• Development of various Questions & Answers (Q&As) on GMP topics
• Formation of a new Good Distribution Practice working group

Inspections and Quality
The group continued work on:

• Nitrosamine contamination and Sartans Lessons Learned
• Updates to the EudraGMDP database
• Monitoring legislative developments in pharmaceutical regulation

Liaison with Other Groups
The GMDP IWG maintained dialogues with:

• Pharmaceutical Inspection Co-operation Scheme (PIC/s)
• International Conference on Harmonisation (ICH) for human and veterinary products
• Various interested parties in the pharmaceutical industry
• Innovation Task Force
• Quality Innovation Group

Source:

EMA: Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2024