Key Regulatory Developments
- EU Pharmaceutical Legislation Reform
- EMA has launched a dedicated webpage to support implementation of the revised EU pharmaceutical legislation, serving as a central hub for updates on preparatory and implementation activities. [EMA Indust...- Issue 1 | PDF]
- Strong emphasis on timely and effective rollout across the EU regulatory network. [EMA Indust...- Issue 1 | PDF]
- Health Technology Assessment (HTA) Regulation
- The EU HTA Regulation, in force since January 2025, establishes coordinated EU-level assessments of clinical effectiveness and safety.
- EMA supports Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs), with initial implementation insights shared after the first year. [EMA Indust...- Issue 1 | PDF]
- Biosimilars – “Biosimilars 2.0”
- EMA reaffirmed its commitment to maintaining a robust scientific and regulatory framework to support biosimilar development in the EU, with a focus on patient and healthcare system benefit. [EMA Indust...- Issue 1 | PDF]
Efficiency and International Alignment
- Artificial Intelligence in Medicines Development
- EMA and the U.S. Food and Drug Administration (FDA) jointly agreed on ten principles for good AI practice across the medicines lifecycle, reinforcing regulatory convergence in AI-enabled development. [EMA Indust...- Issue 1 | PDF]
- OPEN Framework Expansion
- The OPEN framework has been broadened to include:
- Advanced Therapy Medicinal Products (ATMPs)
- Other medicines addressing unmet medical needs
- Certain post-authorisation procedures
- Updates include process improvements and a revised Q&A following industry consultation. [EMA Indust...- Issue 1 | PDF]
- The OPEN framework has been broadened to include:
Guidance, Tools, and Publications
- ICH Q9(R1) Quality Risk Management
- EMA and the European Commission continue to support implementation through new training resources following the 2023 revision of ICH Q9(R1). [EMA Indust...- Issue 1 | PDF]
- Real-World Data (RWD)
- Publication of the Data Quality Framework for EU Medicines Regulation, providing recommendations for assessing RWD used to generate real-world evidence (RWE) in regulatory decision-making. [EMA Indust...- Issue 1 | PDF]
- Name Review Group (NRG)
- Updated Q&A guidance released for completing the electronic NRG Form. [EMA Indust...- Issue 1 | PDF]
Upcoming EMA Events
- Industry Standing Group (ISG) Meeting
- 31 March 2026 | EMA / Online (by invitation)
- Topics include pharmaceutical legislation reform, HTA interface, shortages, and extended mandate activities. [EMA Indust...- Issue 1 | PDF]
- Product Management Service (PMS) Information Day
- 9 June 2026 | EMA and online (live broadcast)
- Focus on PMS strategic direction and network objectives. [EMA Indust...- Issue 1 | PDF]
Open Consultations – Action Required
- GMP Annex 15 (Qualification and Validation) – by 9 April 2026
- ICH E22 Patient Preference Studies (Step 2b) – by 16 April 2026
- Radiopharmaceuticals Quality Guideline (Rev. 2) – by 30 April 2026
- Microbiome-Based Medicinal Products (Concept Paper) – by 30 April 2026
- Clinical Trials During Public Health Emergencies – by 30 April 2026
- ARDS Clinical Investigation Guideline (Rev. 2) – by 1 June 2026[EMA Indust...- Issue 1 | PDF
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