The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a position paper on the European Health Data Space (EHDS) Regulation’s opt-out mechanism, addressing challenges and recommendations for implementing this in EU Member States. The paper highlights the need to avoid data fragmentation and bias, clarify the opt-out scope to personal data, and establish a centralised system. It warns that widespread opt-outs, particularly from certain groups, could reduce data representativeness, and recommends excluding anonymised data while reporting opt-out percentages to data users.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published recommendations for the EU's 2028-2034 Multiannual Financial Framework, focusing on funding requirements for implementing pharmaceutical regulatory reforms. The document outlines resource needs for the European Medicines Agency to execute the revised General Pharmaceutical Legislation, implement a single approval process for multi-country clinical trials, and support the adoption of new chemical and environmental regulations. EFPIA calls for dedicated funding to maintain regulatory competitiveness, enhance data infrastructure, and enable AI implementation in medicine lifecycle management. The recommendations also address requirements for implementing forthcoming sustainability legislation and establishing an EU platform for ethical reviews.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has put forward a detailed proposal to tackle medicine shortages across Europe. The plan calls for a harmonised EU shortage prevention and mitigation system, including a standardised definition of shortages and an interoperable IT monitoring system. The EFPIA advocates for a risk-based approach focused on critical medicines, improved transparency of patient demand, and enhanced supply security through EU-owned strategic reserves. The proposal also recommends regulatory flexibilities to facilitate stock reallocation, measures to strengthen the EU manufacturing base, and efforts to boost global supply chain resilience through international partnerships. These recommendations aim to ensure a more robust and responsive pharmaceutical supply chain whilst maintaining a focus on innovation and patient access to medicines.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), along with AESGP and Medicines for Europe, has proposed a phased implementation of electronic Product Information (ePI) for medicinal products. The associations have published joint recommendations advocating for ePI to be fully operational within four years of the revised General Pharma Legislation's enactment. The proposal includes gradual phasing out of paper leaflets, improvements to Patient Information Leaflet content, and the establishment of a centralised EMA portal. These changes aim to enhance patient safety, regulatory efficiency, and environmental sustainability while ensuring medicine availability across European markets.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has put forward nine recommendations aimed at optimising the EU's forthcoming Framework Programme for Research and Innovation (FP10). Key proposals include allocating 20% of the FP10 budget to health priorities, establishing an EU Office of Life Sciences to co-ordinate with industrial policies, simplifying administrative procedures for industry participants, and adapting intellectual property rules to facilitate swift commercialisation of research outcomes. EFPIA emphasises the need to enhance Europe's competitiveness in health and life sciences research, calling for increased funding across the innovation pipeline and greater flexibility in programme implementation to attract key stakeholders and strengthen the EU's position as a global innovation hub.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its 2024 pipeline review, revealing significant progress in pharmaceutical innovation. The report indicates that the European Medicines Agency has issued 97 new market authorisations this year, including 56 new active substances. Oncology continues to dominate clinical research, accounting for 29% of trials. The review also highlights advancements in antimicrobial resistance vaccines, mRNA vaccines for cancer treatment, novel therapies for major depressive disorder and gene therapies for rare diseases. However, the report underscores the urgent need for incentives to bolster antimicrobial development, with only four innovative antimicrobials currently in the pipeline. EFPIA emphasises the importance of supportive policies and collaborative approaches to sustain Europe's health security and innovation capabilities.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published the 2024 first quarterly edition of the Navigating Innovation & Research Opportunities (NIRO), which lists Research and Innovation (R&I) funding opportunities currently available from various programmes and initiatives both at the EU level and from national ministries, agencies, and organisations within and beyond the EU. By completing a short questionnaire, individual researchers and research teams from the private, public, and not-for-profit sectors, as well as academia, are able to identify which R&I initiatives could be the right fit. The next quarterly update is planned for June 2024.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its annual Patients Waiting to Access Innovative Therapies (WAIT) Indicator analysing access and availability of 168 new medicines across 36 countries, showing widening inequality and longer waiting times for patients in Europe. The data for medicines authorised between 2021–24 indicates a median time to availability of 532 days, ranging from 56 days in Germany to 1,201 days in Romania, with an 88% access disparity between countries. Access has also worsened, with 49% of medicines not available in 2025, 17% only available under restricted conditions, and full availability on public reimbursement lists declining to 28%, with delays linked to regulatory processes, evidence requirements and insufficient budgets. The report also highlights a decline in U.S. Food and Drug Administration (FDA) approved medicines subsequently approved by the European Medicines Agency and warns that factors such as the US Most Favoured Nation Policy (MFN), an uncertain EU market and companies prioritising the US may further impact patient access. EFPIA states that improving access will require faster processes, including ‘Day 1 access’ after approval and increased spending on new medicines, alongside collaborative action between Member States, the European Commission and stakeholders to reduce delays and improve availability.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a white paper on circular economy in response to the European Commission’s Circular Economy Action Plan, roadmap and the European Green Deal highlighting its support. The EFPIA is supportive of the action plan and considers circularity as an opportunity to drive new opportunities for growth, and reduce the demand for emission-intensive materials but notes that circularity and pharmaceutical regulation must be carefully balanced and take into consideration wider influences.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a report analysing biopharmaceutical strategies in ten countries, concluding that the sector has become part of a global race for innovation and industrial competitiveness, alongside artificial intelligence (AI) and quantum technologies, as governments increasingly orient research and development (R&D) and industrial policy around economic and national security objectives. The analysis shows that the US and China are accelerating investment and innovation, while the broader Asia-Pacific pipeline now accounts for roughly one-third to nearly one-half of global innovative drug development, with China contributing about 23%. EFPIA warns that Europe’s relative position has weakened, with EU pharmaceutical R&D spending growing more slowly than in the US and China over the past decade, citing fragmented regulation, administrative burdens arising from duplicative requirements, slower clinical trial processes and persistent gaps in late-stage financing. The report urges the EU to prioritise completion of the single market, the creation of faster and more predictable regulatory pathways, and the mobilisation of late-stage capital through EU-level instruments and public co-investment mechanisms.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a document co-created with the International Pharmaceutical Congress Advisory Association (IPCAA), detailing the legal and ethical standards applicable to industry-sponsored medical congresses in Europe. Published in July 2025, the guide aims to clarify compliance rules for organisations unfamiliar with the EFPIA Code and EU legislation, ensuring consistent standards and transparency across the sector.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a position paper on artificial intelligence (AI). In the paper, EFPIA states that it fully embraces the benefits of AI powered solutions on the healthcare ecosystem and makes seven recommendations for future AI policy development.