Table of Contents
- Understanding the EMA GMP Revisions
- Key Changes in Chapter 4 and Annex 11
- The Introduction of Annex 22 for AI
- Impact on Healthcare Delivery
- Telehealth Perspective: Bridging Technology and Patient Care
- Dr Telx’s Approach to Technology Governance
- Conclusion
The European Medicines Agency (EMA) has launched a significant consultation on revisions to Good Manufacturing Practice (GMP) guidelines. This includes updates to Chapter 4 (Documentation), Annex 11 (Computerized Systems), and a new Annex 22 specifically addressing artificial intelligence in pharmaceutical manufacturing. These changes represent a major shift in how pharmaceutical companies will handle documentation, computerized systems, and emerging AI technologies in the production of medicines.
Understanding the EMA GMP Revisions
The EMA’s three-year work plan (2025-2027) focuses on supply chain integrity, product quality, and adapting to new manufacturing technologies. These revisions come at a critical time when healthcare delivery is increasingly technology-dependent.
As healthcare providers who rely on pharmaceutical products to treat our patients, Dr Telx recognizes the importance of these regulatory updates. Quality medications are the foundation of effective treatment plans, and these regulations help ensure that digital systems supporting pharmaceutical manufacturing maintain the highest standards.
Key Changes in Chapter 4 and Annex 11
The revised Chapter 4 elevates documentation requirements, placing risk management at the center of data governance. This ensures documentation in all formats—text, image, video, or audio—remains complete and legible throughout its lifecycle.
Meanwhile, the updated Annex 11 strengthens requirements for computerized systems, applying quality risk management principles to all stages. This includes enhanced oversight of suppliers and external service providers, improved controls for data integrity, audit trails, electronic signatures, and system security.
From our telehealth perspective at Dr Telx, these changes mirror our own evolution. As we’ve expanded our digital healthcare platform, we’ve similarly had to strengthen our documentation practices and system validation processes to ensure patient data remains secure and accurate.
The Introduction of Annex 22 for AI
Perhaps most forward-thinking is the addition of Annex 22, setting clear requirements for using artificial intelligence and machine learning in pharmaceutical manufacturing. The guidance details model selection, training, validation, and ongoing oversight—including change control and performance monitoring.
Notably, the annex specifically excludes generative AI and large language models from critical GMP applications, recognizing the current limitations of these technologies in high-risk manufacturing contexts.
Impact on Healthcare Delivery
These regulatory changes will ultimately benefit patients by ensuring medications are manufactured with consistent quality and safety standards. As medications become increasingly complex, robust digital systems are essential for maintaining quality.
However, pharmaceutical companies face significant implementation challenges. They’ll need to review documentation processes, validate legacy systems, and develop governance frameworks for AI technologies—all while maintaining continuous operations.
Telehealth Perspective: Bridging Technology and Patient Care
At Dr Telx, we see clear parallels between these pharmaceutical regulations and our telehealth operations. Both fields are navigating the integration of advanced technologies while maintaining unwavering commitment to safety and quality.
Our telehealth platform similarly requires robust documentation systems, computerized system validation, and careful implementation of AI tools. We understand the challenge of balancing innovation with safety, as we continuously enhance our virtual care capabilities while ensuring patient data remains protected.
For example, our symptom assessment tools use algorithms that must be validated, monitored, and updated—similar to how pharmaceutical manufacturers will need to validate AI models under the new Annex 22. The difference is in application, not principle.
Dr Telx’s Approach to Technology Governance
We believe that technology governance in healthcare should be guided by three principles: transparency, validation, and continuous oversight. These principles align closely with the EMA’s approach in the revised GMP guidelines.
In our telehealth practice, we implement these principles by documenting our clinical decision support systems, validating our digital tools against established medical standards, and continuously monitoring system performance.
When we implement new technologies—whether for patient scheduling, medication management, or clinical decision support—we follow a structured validation process that ensures the technology serves its intended purpose without introducing new risks.
This approach has helped us maintain quality care while expanding access through technology. Similarly, pharmaceutical manufacturers can use these GMP revisions as an opportunity to strengthen their quality systems while embracing innovation.
Conclusion
The EMA’s revisions to GMP guidelines represent an important step forward in adapting pharmaceutical regulations to the digital age. By strengthening documentation requirements, enhancing computerized system validation, and establishing clear boundaries for AI implementation, these revisions will help ensure that medicines continue to meet the highest standards of quality and safety.
As healthcare providers at Dr Telx, we welcome these changes and recognize their importance in our interconnected healthcare ecosystem. While we operate in telehealth rather than pharmaceutical manufacturing, we share the commitment to quality, safety, and appropriate technology implementation that underlies these regulatory updates.
The pharmaceutical industry has until October 7, 2025, to provide feedback on these important changes. We encourage all stakeholders to engage constructively in this consultation process to ensure that the final guidelines strike the right balance between innovation and patient safety.