The European Medicines Agency (EMA) has published its third annual report on its Real-World Evidence (RWE) framework, covering February 2024 to February 2025. The report details a 47.5% increase in RWE studies to 59 total, with the DARWIN EU network expanding to 30 data partners across 16 countries, covering 180 million patients. The framework achieved a 78% feasibility rate for studies, up from 60% previously, with a median completion time of 4 months. Studies focused on drug utilisation (42%), safety monitoring (24%) and disease epidemiology (24%), supporting regulatory decision-making across multiple EMA committees and stakeholders.

The European Medicines Agency (EMA) has published a comprehensive review of its regulatory response to nitrosamine impurities in medicines since 2018. The report outlines key developments including the Call for Review requiring marketing authorisation holders to evaluate nitrosamine risks, establishment of the Nitrosamine Implementation Oversight Group, and introduction of the Carcinogenic Potency Categorization Approach in July 2023. The framework includes ongoing market surveillance and international collaboration through the Nitrosamine International Technical Working Group. An addendum to ICH M7 Guideline on assessment and control of mutagenic impurities is being developed, with completion targeted for May 2028. The EMA continues to update guidance based on emerging scientific developments.

The European Medicines Agency (EMA) has published a revised version of its Anti-Fraud Strategy 2021, building on the progress made since the adoption of the first strategy. While the implementation of the previous action plan is largely complete, several significant developments have occurred since, notably legislative initiatives that have introduced new tasks and responsibilities for the agency.

The European Medicines Agency (EMA) has revised its guidance on good manufacturing and distribution practices (GMP/GDP). A new question and answer has been added to a section about an annex on certification by a qualified person and batch release. The new question asks how the traceability of the supply chain of the active substance and medicinal product should be documented to support the qualified person batch certification and release.

The European Medicines Agency (EMA) has published revised policies on handling competing interests for scientific committee members, experts, and Management Board members. EMA has adopted these policies in December 2024, to be effective from May 2025. The revisions, particularly to Policy 0044, implement recent Court of Justice rulings and aim to ensure objective impartiality in EMA's assessments. The agency conducted a public consultation on the draft revised Policy 0044 and has published stakeholder comments and responses. These updates reflect EMA's commitment to maintaining a robust framework for managing competing interests whilst aligning with legal requirements.

The European Medicines Agency (EMA) has published a concept paper on how it intends to draft a reflection paper on the use of external controls, such as through the collection of real-world data or derived from data from other trials or data sources, instead of using randomised controls to support the clinical evidence submitted in an application seeking authorisation of a treatment from the regulator. Currently, no guidance addresses this issue and there is not a standard definition of 'external controls'. Randomised controlled trials are considered the 'gold standard' for evaluating the benefits and risks of medicines in regulatory decision-making, there are circumstances where conclusions can be drawn from data collected under a clinical trial protocol where the control group was not randomised. In these circumstances, the external control may be derived from data from other clinical trials or real-world data (RWD). There is a need for more information on the methodological reliability and operational aspects of this approach. The Reflection Paper is intended to define what is meant by an external control; the appropriate clinical and regulatory setting and minimal requirements for external controls; operational and feasibility aspects; planning, design, conduct, analysis and reporting of studies for which external controls are used; and considerations to minimise bias. EMA said it plans to release a draft reflection paper for public consultation in the fourth quarter of 2026, followed by a three-month consultation, and to adopt a guideline in the second quarter of 2027. The concept paper was issued two months after the UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued a draft guideline on a similar topic (LNB News 20/05/2025 18)

The European Medicines Agency (EMA) has published updated Q&A guidance on good manufacturing and distribution practice. The updates are a series of Q&As relating to the EU good manufacturing practice (GMP) guide annexes: Supplementary requirements: Annex 8: Sampling of starting and packaging materials: Glycerol and other excipients at high-risk of DEG/EG contamination.

The European Medicines Agency (EMA) has updated guidance on good manufacturing and distribution practices (GMP/GDP), adding questions and answers on the basic requirements for active substances used as starting materials. EMA added two questions about third-party audit reports clarifying that manufacturers may contract with third parties to undertake relevant audits. Ultimately, it explained that the Qualified Person is responsible for ensuring audit reports are properly evaluated when the audit is performed by a third party'. The written final assessment text should provide a 'comprehensible summary' of the evaluation. EMA said assessments should include 'all expected elements of the auditing process and audit report(s) identified before, during, and after the audit'. 'This includes verification of contractual arrangements, scope and appropriate duration of audit, adequate competence of auditors considering the scope of the audit, planned audit frequency, and CAPAs whether adequate and how these are to be followed up' the Q&A states. also, any conflicts of interest identified should be discussed.​

The European Medicines Agency (EMA) has announced that it is currently working on the onboarding of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) for medicinal products on IRIS. To this end, the EMA released a video and updated Q&A guidance on RPM for PLM on 19 February 2024. These addressed its first rollout for selected products (ie a subset of 67 human generic products and 44 veterinary products) occurring on 23 January 2024, covering Variations, Article 61.3 Notifications, and Marketing Authorisation Transfers procedures. The aim is process simplification and standardisation for marketing authorisation holders (MAHs), thus allowing the decommissioning of SIAMED.

The European Medicines Agency (EMA) has published Version 1.5 of its external guidance on the implementation of Policy 0070, which governs the publication of clinical data for medicinal products for human use. The updated guidance clarifies and consolidates procedures relating to the submission, anonymisation, and redaction of clinical reports submitted in centralised marketing authorisation procedures. It provides revised instructions for applicants and marketing authorisation holders (MAHs) on the preparation of redacted and anonymised clinical documents, including the use of mandatory templates for justification tables and anonymisation reports.

The European Medicines Agency (EMA) has implemented revised policies for handling competing interests, effective from 1 May 2025. Policy 0044 for scientific committee members and Policy 58 for Management Board members introduce stricter restrictions on current interests, establish a unified three-year cooling-off period for past pharmaceutical industry employment, and strengthen oversight of medical device industry interests. The changes align both policies with Court of Justice rulings in joined Cases C-6/21 and C-16/21 P (Aplidin case) and Case C-291/22 P (D&A Pharma v Commission and EMA). The policy applies to all EMA scientific committees, working parties and bodies including the Emergency Task Force and Executive Steering Groups.

The European Medicines Agency (EMA) has updated its guidance on biosimilar medicines, focusing on marketing authorisation and post-market variations. Biosimilars must demonstrate high similarity to reference medicines through comprehensive comparability studies. EMA's tailored scientific advice pilot project supports biosimilar development by advising on necessary studies. The new guidance includes a Q&A on safety variations, requiring type IB variation applications for centrally authorised biosimilars within two months of changes to the reference product's information.