The European Medicines Agency (EMA) has published guidance on how to comply with the provisions of the amended Regulation (EU) 2024/1701 (the amended Variations Regulation), which will apply to new variation applications implemented and submitted to the EMA from 1 January 2025, in hopes to make lifecycle management more efficient. The guidance provides information on the implementation of the amended Variations Regulation, which includes amendments to the Article 5 procedure, the annual update for minor variations of Type IA, the procedure for grouping and super-grouping of Type IA variations, the annual update of a human influenza or human coronavirus (COVID-19) vaccine, the mandatory and voluntary use of the work sharing procedure, the variations to human medicines for public health emergencies and to the Annexes. The guidance also provides recommendations on unforeseen variations. Any variation applications submitted before 1 January 2025 should follow the current provisions set out in Regulation (EC) 1234/2008, as amended by Commission Delegated Regulation (EU) 2021/756.

The European Medicines Agency (EMA) has published guidance on implementing shortage prevention plans (SPPs) for marketing authorisation holders (MAHs). Under Article 117(1) of the provisionally agreed text of the proposed Pharmaceutical Regulation, MAHs will be required to establish and maintain an up-to-date SPP for medicines subject to medical prescription, as well as any additional medicines identified by the European Commission. The guidance, developed in collaboration with the Medicines Shortages Single Point of Contact Working Party (SPOC WP), sets out the type and detail of information required, with the degree of formalisation and documentation proportionate to the identified risk level for each medicine. An SPP template specifying the minimum information is included in an annex.

The European Medicines Agency (EMA) has published guidance on submitting electronic product information (ePI) for centrally authorised medicines through the Product Lifecycle Management portal. The guidance will apply from ePI go-live and covers the creation, updating and submission of ePI for marketing authorisation applications and post-authorisation procedures. Until the revised EU pharmaceutical legislation is fully applicable, submission will remain voluntary. Applicants may submit ePI in English during this phase, while translations into other EU languages, including Icelandic and Norwegian, are optional. Applicants must continue to submit approved product information annexes through the electronic Common Technical Document process and ensure that published ePI remains aligned with the latest approved product information.

On 28 November 2024, the European Medicines Agency (EMA)’S Pharmacovigilance Risk Assessment Committee adopted new guidelines on the use of specific adverse reaction follow-up questionnaires (Specific AR FUQs) in routine pharmacovigilance activities. The guidelines, set to take effect on 1 February 2025, outline when and how to use Specific AR FUQs, recommending their use for safety concerns that may impact a product's benefit-risk balance. The document provides guidance for Marketing Authorisation Holders (MAHs) on developing Specific AR FUQs, as well as considerations for their discontinuation and removal. It also details requirements for the content, format, and dissemination of Specific AR FUQs. The EMA notes that the guidelines do not intend to modify MAHs' internal policies for FUQs.

The European Medicines Agency (EMA) has confirmed that the International Council for Harmonisation (ICH) E2D(R1) guideline on post-approval safety data will take effect in the EU on 18 March 2026, and issued an implementation strategy ahead of that date to support the transition to the revised pharmacovigilance requirements. The strategy, adopted by EMA’s Pharmacovigilance Risk Assessment Committee on 20 February 2026, is dated 26 February 2026 and was published on 6 March 2026, providing guidance to marketing authorisation holders, national competent authorities and inspectors before the updated rules become effective. The revised guideline updates internationally harmonised definitions and standards for managing and reporting post-authorisation safety information, including requirements for individual case safety reports (ICSRs) and guidance on handling safety data from sources such as digital platforms, patient support programmes, market research programmes and non-interventional studies.

The European Medicines Agency (EMA) has published recommendations developed by its Medicines Shortages Steering Group (MSSG) to facilitate the availability and supply of critical human medicines, address vulnerabilities in the production and delivery of these medicines, and strengthen their supply chain. The EMA, European Commission and the Heads of Medicines Agencies have developed the first version of a Union list of critical medicines. For these listed medicines, the MMSG may propose measures to address vulnerabilities in their supply chain and strengthen their security of supply.

The European Medicines Agency (EMA) has published a draft reflection paper encouraging the systematic inclusion of patient experience data (PED) in medicines development and regulatory submissions. PED refers to data directly reported by patients or carers—without interpretation by clinicians or third parties—and can provide valuable insights into treatment preferences, quality of life, and real-world outcomes. The paper is intended for medicine developers, regulators, researchers and patient groups, and sets out general principles for collecting and analysing PED across the lifecycle of medicines. Responses are sought by 31 January 2026.

The European Medicines Agency (EMA) has published its closing report titled 'Boosting the development of medicines for children' that aims to highlight the key achievements of the action plan on paediatrics four years after its publication. The key improvements include a strengthened focus on unmet medical needs, adapting regulatory processes to better support innovation, and the increased alignment of data requirements between decision-makers. This report outlined how the paediatric action plan has provided a framework for improving the implementation of Regulation (EC) No 1901/2006 (the Paediatric Regulation) in a collaborative effort between stakeholders. Additionally, the EMA has published guidance for the stepwise Paediatric Investigation Plan (PIP) pilot where this consists of only a partial development programme, conditional on the development of a full PIP once crucial information has become available. This will be piloted in the first quarter of 2023.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies have published revision 2 of Module III of their good pharmacovigilance practices (GVP) guidance on pharmacovigilance inspections. The revised module reflects amendments to Commission Implementing Regulation (EU) No 520/2012, made by Commission Implementing Regulation (EU) 2025/1466, which applied from 12 February 2026. It clarifies that competent authorities may inspect third parties subcontracted by marketing authorisation holders to carry out pharmacovigilance activities, even where the subcontract does not require the third party to agree to an inspection. The guidance also reflects experience of remote inspections. Inspectorates may decide case by case whether a remote inspection provides an adequate view of a pharmacovigilance system, including where key sites are outside the EU. It also states that authorities may carry out pre-authorisation inspections to verify the accuracy and implementation of the pharmacovigilance system described in an application for marketing authorisation.

The European Medicines Agency (EMA) has published a revised draft reflection paper outlining non-animal replacement tests for pharmaceutical testing. The document aligns with the 3Rs principles and updates the 2018 version, complementing the 2016 guideline on regulatory acceptance of 3Rs approaches. It provides a comprehensive overview of regulatory requirements across various EMA working parties, highlighting alternatives such as the rFC method for endotoxin testing and the monocyte activation test for pyrogen testing. The paper also notes the elimination of animal tests for certain radiopharmaceutical distribution studies. EMA aims to encourage sponsors to develop and submit new 3Rs methodologies for regulatory review and acceptance. The deadline for commenting is 30 June 2025.

The European Medicines Agency (EMA) has published two key documents on real-world evidence on 3 April 2025: a roadmap for regulatory guidance development and a reflection paper on using real-world data in non-interventional studies. The reflection paper, which underwent public consultation between May and August 2024 receiving 700 stakeholder comments, provides methodological guidance for using real-world data in regulatory submissions. The documents aim to establish a framework for integrating real-world evidence into regulatory decision-making across the European medicines regulatory network.

The European Medicines Agency (EMA) has published its scientific guideline for the clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/2005) that are intended to prevent infectious diseases. The guideline includes the considerations for trials intended to document the safety, efficacy and immunogenicity of new candidate vaccines. It also considers the need and use of vaccine effectiveness studies. The scientific guideline will be effective as of 1 July 2023.