The European Medicines Agency (EMA) has published the outcomes of its 21st Industry Stakeholder Platform on the Operation of EU Pharmacovigilance Legislation, held on 20 October 2026. The discussions covered artificial intelligence (AI) in safety monitoring, the expansion of the DARWIN EU real-world evidence network, EudraVigilance reporting performance and upcoming revisions to Good Pharmacovigilance Practices (GVP). Several developments have direct implications for marketing authorisation holders, particularly regarding signal monitoring, periodic safety reporting and risk management plans.

AI applications move into pharmacovigilance pilot deployment

EMA presented two AI-enabled initiatives currently in pilot deployment: EurEKA and ERATO. The EMA presentation on AI in pharmacovigilance provides further details.

EurEKA (European Union Product Information Entity Extraction and Knowledge Acquisition) extracts adverse drug reaction (ADR) information from Summaries of Product Characteristics (SmPCs), making the data searchable and comparable across medicinal products. Its architecture combines regular expressions, a pre-trained machine-learning model and large language model (LLM)-enabled functionality. The pilot has mapped approximately 155,000 ADRs across around 1,500 centrally authorised products.

ERATO (Enhanced Review of Abstracts with Transformer Models) uses generative AI to screen scientific literature for emerging safety signals. According to EMA, the system has reduced the number of abstracts requiring manual review by approximately 70%.

The Agency also outlined potential applications across the pharmacovigilance workflow, including duplicate detection, literature screening for individual case safety reports (ICSRs), case adjudication and analysis of historical signal assessments.

Industry representatives presented experimental results illustrating both the potential and limitations of generative AI. These included 78% accuracy in mapping signs and symptoms to MedDRA Preferred Terms and 73% consistency when using a retrieval-augmented generation interface for pharmacovigilance procedures. The results relate to specific industry experiments rather than validated performance benchmarks established by EMA.

Participants highlighted the risks associated with non-deterministic outputs, hallucinations, model drift and incomplete information. Human oversight, validation against curated datasets, auditability, data protection and continuous performance monitoring were identified as essential safeguards.

EMA is also developing a Questions and Answers document on AI in pharmacovigilance. Its scope was informed by a stakeholder survey involving 176 respondents. A draft for public consultation is anticipated in the second quarter of 2027.

In addition, EMA will participate in a five-year Innovative Health Initiative (IHI) public-private partnership on AI-powered signal detection, scheduled to start in January 2027. The project will address signal detection and risk prediction models, data sources, implementation approaches and human oversight.

EudraVigilance: 25 years of safety reporting

EMA marked the 25th anniversary of the EudraVigilance Gateway, established in November 2001.

As of August 2026, the system contained 18.5 million individual cases, representing more than 32 million case transactions. It received approximately 7,400 ICSR transactions per day in 2025.

Since 2012, more than 900 safety signals have been prioritised and assessed by the Pharmacovigilance Risk Assessment Committee (PRAC). These assessments resulted in 54 product information changes and 50 Direct Healthcare Professional Communications (DHPCs).

EMA also reviewed the first year of automated monthly ICSR compliance monitoring through the EudraVigilance Data Analysis System (EVDAS).

For the period from 1 October 2025 to 30 September 2026, average industry compliance remained high across all four reporting streams:

• 98.17% for 90-day post-marketing reporting (EVPM)
• 97.31% for fatal or life-threatening clinical trial cases (EVCTM)
• 98.30% for non-fatal and non-life-threatening clinical trial cases (EVCTM)
• 96.57% for 15-day post-marketing reporting (EVPM)

EMA identified operational issues involving QPPV registration, sender identifiers, discrepancies between internal submission records and EudraVigilance data, and communication between pharmacovigilance and case-processing teams.

The Agency plans to provide a more detailed analysis of industry compliance at the second HMA/EMA multi-stakeholder forum on EudraVigilance and signal detection, scheduled for 1 December 2026.

DARWIN EU expands its role in regulatory decision-making

The Data Analysis and Real World Interrogation Network (DARWIN EU) now includes 40 data partners across 18 European countries, providing access to healthcare data covering more than 250 million people.

More than 100 studies have been completed, with the total number of completed and ongoing studies approaching 150.

EMA reported that standardised analytics based on a common data model can deliver routine drug-utilisation studies in approximately three months. More complex safety and effectiveness studies typically require five to six months.

Examples of recent work include a study that found no association between doxycycline use and suicidality, research on clozapine-associated agranulocytosis that contributed to revised blood-monitoring recommendations, and investigations into GLP-1 receptor agonist utilisation and adverse reactions.

Other studies have examined the real-world effectiveness of first-line immunotherapy in non-small-cell lung cancer.

EMA emphasised that real-world evidence (RWE) complements rather than replaces pivotal randomised studies or marketing authorisation holders’ existing post-authorisation study obligations. Potential applications include external comparator arms and investigations involving specialised patient populations.

Changes to GVP and periodic safety reporting

The meeting covered several developments affecting EU Good Pharmacovigilance Practices and periodic safety reporting.

GVP Module IX, Revision 2: changes to signal monitoring

Following the termination of the EudraVigilance signal-monitoring pilot and amendments to Commission Implementing Regulation (EU) No 520/2012, marketing authorisation holders are no longer required to carry out continuous signal monitoring of EudraVigilance or submit standalone notifications of validated signals to EMA and national competent authorities. However, they remain required to monitor the data available in EudraVigilance and use it alongside information from other available sources.

Companies may continue using EudraVigilance as a primary source for signal detection or as a source of information during the validation and assessment of signals identified elsewhere.

Monitoring frequency must be proportionate to risk and documented. PSURs and variations remain the principal regulatory instruments for addressing signals. Where a signal assessment leads to the conclusion that product information should be updated, the relevant variation should be notified no later than three months after signal validation.

GVP Module V, Revision 3: revised approach to risk management plans

The draft revision of GVP Module V and its associated Risk Management Plan (RMP) template has returned to the drafting group.

The revision aims to simplify safety specifications, reduce duplication with clinical safety assessments and focus RMP content on additional pharmacovigilance activities and additional risk-minimisation measures.

The additional drafting work is expected to delay public consultation by approximately six months. ATMP-specific guidance is also planned for inclusion in the consultation.

PSUSA assessment reports: proposed industry pre-filling pilot

EMA outlined a proposed voluntary pilot for 2027 under which selected marketing authorisation holders would pre-fill specified factual sections of Periodic Safety Update Report Single Assessment (PSUSA) report templates.

The initiative is intended to reduce administrative work for assessors and allow greater focus on scientific evaluation.

The proposed scope covers centrally authorised product-only procedures and nationally authorised product-only procedures involving a single marketing authorisation holder.

Subject to PRAC endorsement, EMA intends to publish the templates and information about the pilot by December 2026, with a provisional one-year launch in February 2027.

Separately, EMA intends to request summary tabulations and relevant case tables in Excel format for all PSUSA procedures from early 2027.

Revised guidance on medicines during pregnancy and breastfeeding

Separately from the recently revised GVP guidance on pregnant and breastfeeding women, the joint CHMP-PRAC guideline on risk assessment of medicinal products in relation to human reproduction and lactation is undergoing revision.

The updated document will address fertility, pregnancy and breastfeeding, including standardised wording for Summaries of Product Characteristics and package leaflets.

It will also expand the assessment of exposure through breast milk, estimated infant exposure, adverse pregnancy outcomes and neurodevelopmental effects. New approach methodologies and weight-of-evidence assessments are among the methodological aspects addressed.

Adoption by PRAC and CHMP was anticipated in November or December 2026, followed provisionally by a three-month public consultation.

CMDh plans greater transparency in national pharmacovigilance procedures

The CMDh Work Plan 2026–2028 includes measures to improve access to safety-related regulatory outcomes for nationally authorised medicinal products.

Planned initiatives include structured publication of PRAC advice to Member States, information on important safety variations, lists of safety concerns and guidance on additional risk-minimisation measures in mutual recognition and decentralised procedures.

For important safety variations, the CMDh intends to publish national competent authority safety summaries alongside updated product information prepared by marketing authorisation holders.

The group is also developing guidance on additional risk-minimisation measures, initially focusing on patient cards and greater consistency across European procedures.

These initiatives are intended to make safety-related regulatory decisions easier to identify and follow across the EU regulatory network.