The GMDP IWG Meeting
The GMDP IWG includes senior Good Manufacturing Practice (GMP) inspectors from the European Economic Area member states (European Union countries, plus Norway, Iceland, and Liechtenstein), representatives from the European Commission (DG Enterprise and Industry), and observers from the European Directorate for the Quality of Medicines (EDQM), FDA, WHO, EU accession countries, and nations with Mutual Recognition Agreements or trade agreements.
ISPE, a recognized EMA stakeholder and part of the 16-association group coordinated by the European Federation of Pharmaceutical Industries and Associations (EFPIA), has contributed to the EMA IWG since 2013.
The interested parties are invited to meet with the GMDP IWG annually. In the months leading up to each meeting, the associations propose topics for discussion with the EMA, often accompanied by an industry position brief. These briefs are drafted by the association designated as the lead on the topic, with input from supporting associations.
Since October 2023, over 250 people—including 60 EMA inspectors—have completed PIC/S quality risk management training.
ISPE Served as the Lead for the Following Topics
- EU-GMP Chapter 1: Quality Risk Management
- Annex 11/Chapter 4: Computerized System Validation and Documentation
- Annex 15: Process Qualification and Validation
- Drug Shortages Prevention
ISPE also acted as a supporting association for:
- Annex 1: Sterile Manufacturing
- Annex 21: GMP for Importers
Updates and Collaboration
The 13 March meeting included updates on several GMP/GDP guidelines in the IWG Working plan:
- The Annex 15 revision, with a focus on facilities, equipment, and process validation draft, will be available later this year. Advanced manufacturing technologies and advanced therapy medicinal products (ATMPs) are not included in Annex 15.
- The Annex 11 revision will be split into two separate Annexes: the existing Annex 11 (20 pages) and a new Annex 22 (8 pages) on artificial intelligence.
- Proposed changes to EudraLex Part 1/Chapter 4 documentation are extensive and will be aligned with the proposed changes to Annex 11, e.g., electronic signatures.
- Since October 2023, PIC/S quality risk management training has reached over 250 participants, including 60 EMA inspectors.
In 2025, the EMA Quality Innovation Group will focus on personalized medicines, decentralized (point of care) manufacturing, and 3D printing.
A standout feature of the meeting was the constructive, structured dialogue and an atmosphere of mutual confidence. The EMA demonstrated genuine openness to feedback and a strong commitment to enhance regulatory processes and collaboration with industry. The EMA’s engagement with industry representatives demonstrated a strong willingness to strengthen its relationship with interested parties.
Preparation
Preparation played a crucial role in the meeting’s success. The pre-meeting discussions with the EMA proved highly beneficial, ensuring that all topics were adequately addressed and the dialogue remained focused and productive. One of the key discussion points during the meeting was the need for EU-wide metrics on inspection findings. Although this was not considered a current priority, it was suggested that the parties consider identifying the top 10 inspection findings to enhance regulatory oversight and improve compliance standards.
Another critical topic was Annex 1, with key issues associated with Annex 1 implementation being discussed. The responses provided were perceived as highly dependent on individual opinions from local health authorities and inspectors. It is clear that industry and regulators need to continue to work together to understand the challenges manufacturers and regulators face collectively and how this can be addressed.
The meeting also shed light on the growing workload of the EMA IWG in 2025. The agency’s increasing responsibilities highlight the importance of harmonization efforts, particularly through organizations like the PIC/S. This aligns with industry expectations for greater regulatory consistency and streamlined compliance frameworks across different jurisdictions. The EMA’s continued willingness to accept comments on drafted guidelines and targeted Q&A sessions was also acknowledged as a positive step toward achieving this goal.
Outcomes
The meeting was regarded as the most successful IWG-IPM, characterized by a high level of collaboration, mutual respect, and a strong commitment to process improvement. A key takeaway: the voice of the industry was heard. The level of preparation by industry stakeholders and the preparation calls with the EMA contributed to the meeting’s success.
The ability to align diverse associations and maintain a well-organized approach to engagement proved instrumental in achieving meaningful outcomes. The meeting set a high benchmark for future engagements, demonstrating that structured, transparent, and well-prepared discussions can lead to tangible improvements in regulatory processes. Continuing collaboration and proactive engagement will be essential in addressing the remaining uncertainties and in ensuring that industry concerns are effectively integrated into the EMA’s regulatory framework.
Looking Ahead
It was suggested that an in-person meeting be scheduled for June 2026, with discussion topics due in February 2026. A face-to-face meeting could consolidate the importance and effectiveness of this collaboration even further. The 2025 interested parties include:
- Active Pharmaceutical Ingredients Committee
- Affordable Medicines Europe
- AnimalhealthEurope
- Association of the European Self-Care Industry (AESGP)
- European Association for Logistics and Transportation in Healthcare
- European Compliance Academy
- European QP Association
- European Federation of Pharmaceutical Industries and Associations
- European Healthcare Distribution Association
- European Industrial Pharmacists Group
- International Pharmaceutical Excipients Certification
- International Pharmaceutical Excipient Council
- International Plasma and Fractionation Association
- ISPE
- Medicines for Europe
- Parenteral Drug Association
- Plasma Protein Therapeutics Association
- Vaccines Europe
