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EFPIA reports on the path to decarbonization

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EFPIA reports on the path to decarbonization

Four years after its last update, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a new edition of its climate change report, providing an overview of the actions undertaken by the innovative pharmaceutical industry to meet the European institutions’ call for the decarbonization of business activities. A total of 28 companies participated in the survey, up from 18 in the 2022 edition.

Key findings of the report

The climate survey conducted among EFPIA members in 2025 points to an acceleration in corporate action, with average Scope 1 emissions reduced by 16% and Scope 2 emissions by approximately 64% between 2019 and 2024. The primary driver behind this trend has been identified as the rapid transition to renewable energy sources. Scope 1 emissions are those generated directly by activities under a company’s control, while Scope 2 emissions are indirect emissions associated with energy produced by third parties but purchased and consumed by the company.

More than half of the companies surveyed (60%) also reported a reduction in Scope 3 emissions—those generated across the company’s entire value chain—by an average of 17%. However, EFPIA notes that achieving meaningful reductions in Scope 3 emissions requires strong engagement and collaboration from suppliers. Between 2019 and 2024, companies also recorded an average 43% reduction in emissions intensity, falling from 21 tonnes CO₂e/mEUR to 9 t CO₂e/mEUR.

The report also highlights that most innovative pharmaceutical companies are actively pursuing Net Zero targets, with nearly all respondents (90%) aligning their goals with the Science Based Targets initiative (SBTi) framework. In this context, companies are increasingly focusing on energy efficiency measures, including HVAC optimization, heat recovery systems, heat pumps and ISO 50001 energy management systems.

The EFPIA survey further reveals a more advanced level of maturity regarding product carbon footprint management, supported by the use of lower-carbon raw materials and greater process circularity. Additional positive developments include the transition to hybrid and electric vehicle fleets and the adoption of refrigerants with a lower Global Warming Potential (GWP).

Most EFPIA member companies (90%) carried out climate risk assessments in 2025, representing a 15-percentage-point increase compared with the 2022 survey. In addition, 80% of companies use internationally recognized Environmental, Social and Governance (ESG) frameworks to support climate-related reporting and management processes.

Looking ahead

Looking to the future, the EFPIA report highlights the importance of regulatory harmonization, whereby Product Category Rules (PCRs) should serve as complementary documents alongside Life Cycle Assessment (LCA) standards. In particular, EFPIA supports the adoption of the “PAS 2090:2025, Pharmaceutical Products – Product Category Rules for Environmental Life Cycle Assessments” framework. Published in November 2025, the standard is the result of collaboration between the Pharmaceutical LCA Consortium and other stakeholders across the pharmaceutical value chain.

EFPIA is calling on institutions and regulatory authorities to recognize PAS 2090 as the most robust approach for the pharmaceutical sector. Another key factor in ensuring effective implementation of the proposed framework will be partnerships, with EFPIA urging closer collaboration with suppliers and technology partners to improve data quality and traceability, as well as the adoption of advanced and weighted methodologies for calculating Scope 3 emissions.

EMA’s SME support programme marks 20 years of activity

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EMA’s SME support programme marks 20 years of activity

The European Medicines Agency’s (EMA) support programme for small and medium-sized enterprises (SMEs) has reached its twentieth year of operation. Since 2005, when the dedicated SME Office was established, more than 5,000 companies have had their SME status officially recognised by the Agency, according to EMA’s latest report. Of these, over 3,000 have received direct assistance and support in the development of human or veterinary medicines.

Key figures on SMEs registered with EMA

In 2025, nearly 2,000 SMEs were registered with EMA, with the largest shares located in Germany (12.2%) and France (10.1%). Italian SMEs accounted for 6.3% of the total. Most companies (81%) operate exclusively in the pharmaceutical sector, while others are active in both pharmaceuticals and medical devices (16%) or solely in the medical device field. More than two-thirds (67%) of pharmaceutical SMEs currently have products under development. Academic spin-offs represent 13% of all registered SMEs, while the report also notes that 7.5% of SMEs have been acquired over the past three years.

In terms of company size, small enterprises account for 35% of the total, micro-enterprises for 38%, and medium-sized companies for 27%. The majority of registered SMEs (77%) focus on human medicines, followed by providers of regulatory and consultancy services (14%). The development pipelines of EMA-registered SMEs are primarily focused on medicinal products (52%), particularly small-molecule medicines, which also represent 52% of projects under development. In addition, nearly one-quarter of the companies are involved in the development of orphan medicines.

Strong contribution to pharmaceutical innovation

The success rate for obtaining marketing authorisations for medicines developed by registered SMEs reached 64% during the 2021–2025 period. In 2025 alone, EMA issued seven positive opinions and one negative opinion, while six applications were withdrawn before the Agency delivered its assessment. The success rate was even higher (80%) for marketing authorisation applications concerning veterinary medicines submitted during the same period.

A significant number of products developed by SMEs and authorised by EMA have addressed unmet medical needs. Around half (46%) of PRIME designations were granted to small and medium-sized enterprises, while recommendations for advanced therapies developed by SMEs accounted for 40% of the total. SMEs have also played an active role in several EMA initiatives designed to foster innovation, including scientific advice and protocol assistance procedures, applications for the qualification of novel methodologies, and participation in briefing meetings with the Innovation Task Force.

Progress in conducting clinical trials in the EU

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Progress in conducting clinical trials in the EU

The first report on the state of clinical trials in Europe, published jointly by the European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) in mid-May, provides an overview of active clinical trials in the first quarter of 2026 and compares current performance with the objectives established under the Accelerating Clinical Trials in the EU (ACT EU) initiative. These targets are also aligned with the proposed EU Biotech Act, currently under review by European co-legislators, and form part of broader efforts to position the European Union as a preferred destination for clinical research while ensuring timely patient access to innovative treatments.

Increase in Multinational Clinical Trials

The first quarter of 2026 recorded an increase in the number of multinational clinical trials, with nineteen more trials authorized than the historical average. This brings the EU closer to its goal of achieving 500 additional multinational clinical trials by 2030, a target that would require the activation of at least 100 new multinational studies per year.

March 2026 recorded the highest number of multinational trial authorizations, with 110 studies approved. Patient recruitment performance also showed improvement, with approximately 40% of studies enrolling the required number of participants within 200 days of the authorization application. The target for 2030 is 66%.

Key Findings of the Report

The report identified a total of 668 clinical trial applications, the majority of which (416) were single-country studies. Among these, non-commercial studies predominated (262).

The opposite trend was observed for multinational trials (252), which were mainly commercial studies (229). A total of 538 authorized studies were monitored in the report, showing a more balanced distribution between multinational trials (232) and single-country trials (306).

The data were obtained from the Clinical Trials Information System (CTIS) and relate to studies falling within the scope of Regulation (EU) No. 536/2014 on clinical trials.

During the first quarter of 2026, an average of 208 applications per month for new clinical trials were submitted through CTIS. The average time from submission to authorization for a new early-phase clinical trial was 118 days.

Since its launch, CTIS has received more than 13,000 clinical trial applications. At the time of publication of the report, approximately 6,400 early-phase clinical trials were ongoing in the EU/EEA under the Clinical Trials Regulation framework.

EMA highlights regulatory challenges and opportunities for radiopharmaceuticals

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EMA highlights regulatory challenges and opportunities for radiopharmaceuticals

The European Medicines Agency (EMA) has highlighted the growing importance of radiopharmaceuticals in healthcare, underlining both the opportunities and regulatory challenges associated with this rapidly evolving field. The observations are included in the Agency’s Horizon Scanning report, published in May 2026, which examines emerging trends likely to influence the future of medicines in Europe.

Radiopharmaceuticals are playing an increasingly significant role in both diagnostic imaging and targeted therapies, particularly in oncology. According to the EMA, the unique characteristics of these medicinal products require a dedicated regulatory approach that considers not only pharmaceutical legislation but also safety standards related to exposure to ionising radiation.

The report notes that radiopharmaceuticals include a broad range of products, such as radionuclide precursors, generators and kits used for in-house preparation. Their development, manufacturing, distribution and clinical use involve technical and logistical requirements that differ substantially from those of conventional medicines.

The need for greater regulatory harmonisation

As scientific knowledge and regulatory frameworks continue to evolve, the EMA stresses the importance of achieving better harmonisation at both European and global levels. Consistent regulatory approaches could facilitate innovation while maintaining high standards of quality, safety and efficacy. The Agency points out that the sector is advancing rapidly, creating new opportunities for personalised medicine but also raising complex regulatory questions. Greater alignment among authorities could help streamline development pathways and support wider patient access to innovative treatments.

Another key theme emerging from the report is the broad range of expertise required throughout the lifecycle of radiopharmaceuticals. From research and development to manufacturing, clinical application and radiation safety, these products involve specialists from multiple disciplines. This complexity makes ongoing collaboration essential. The EMA highlights the value of early and continuous dialogue among stakeholders, including developers, manufacturers, healthcare professionals, researchers and regulatory authorities. Such engagement can help regulators gain a deeper understanding of the scientific, technical and operational challenges specific to the radiopharmaceutical sector.

Supporting future innovation

The report also draws attention to the importance of securing the supply of radiopharmaceuticals. Given their critical role in diagnosis and treatment, any disruption in availability could have a direct impact on patient care. For this reason, the EMA recommends that regulators and policymakers build on the work already carried out by expert groups focused on maintaining supply chains and preventing shortages. Strengthening these efforts will be crucial as demand for radiopharmaceuticals continues to grow across Europe.

Looking ahead, the EMA considers radiopharmaceuticals a strategic area for the future of healthcare and precision medicine. To fully realise their potential, the Agency argues that regulatory systems must continue to evolve, supported by stronger stakeholder collaboration and coordinated actions to address both scientific and supply-related challenges. By fostering harmonisation, encouraging dialogue and safeguarding availability, regulators can help create an environment that supports innovation while ensuring patient safety and access to these increasingly important therapies.

Preliminary agreement on the Critical Medicines Act

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Preliminary agreement on the Critical Medicines Act

On 12 May 2026, the Cyprus presidency of the European Council reached a provisional agreement with the European Parliament on the Critical Medicines Act, a new regulation designed to strengthen the resilience of the European pharmaceutical sector. The initiative is intended to address recurring shortages and improve the long-term availability and security of supply of both critical medicines and medicines considered strategically important for public health across the European Union.

The agreement comes at a time when European healthcare systems continue to face growing pressure linked to supply chain disruptions, geopolitical instability and increasing dependence on non-EU manufacturing for essential pharmaceutical ingredients.

Strengthening supply chains and EU manufacturing

Among the key measures included in the agreement is the diversification of pharmaceutical supply chains, aimed at reducing excessive reliance on a limited number of suppliers or geographic areas. The regulation also promotes joint and collaborative procurement mechanisms between member states, with the objective of improving coordination and ensuring faster access to essential medicines during periods of crisis or shortage.

Another central element of the proposed legislation is the strengthening of manufacturing capacity within the EU, particularly for critical medicines and their active pharmaceutical ingredients (APIs). The goal is to reinforce Europe’s strategic autonomy in the pharmaceutical sector and reduce vulnerabilities linked to external production hubs.

The provisional agreement also introduces new resilience-related requirements for public procurement procedures. Contracting authorities will be required to integrate criteria linked to supply security and continuity when purchasing medicines, encouraging more sustainable and reliable sourcing strategies.

New rules on procurement and contingency stocks

The text also lowers the threshold of member states required to request the European Commission to carry out procurement on their behalf, reducing the minimum number from nine countries to five. This change is expected to facilitate faster and more flexible joint purchasing initiatives among EU members.

In addition, the agreement specifies that contingency stock requirements must remain transparent and comply with the principles of solidarity and proportionality, in order to avoid imbalances between member states and prevent unnecessary pressure on supply systems.

The scope of the regulation has also been expanded to include orphan medicinal products in selected key therapeutic areas, reflecting increasing attention to the availability of treatments for rare diseases.

The provisional agreement will now need to be formally endorsed and adopted by both the Council and the European Parliament before the regulation can enter into force and move towards implementation.

MDR and IVDR revision: industry associations outline their position

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MDR and IVDR revision: industry associations outline their position

The debate over the revision of the EU Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) has recently intensified following the publication of position papers by MedTech Europe and AESGP, representing respectively the medical device and self-care sectors. Both associations broadly welcomed the European Commission’s proposal to simplify the current framework, while also highlighting critical issues and proposing targeted amendments. 

MedTech Europe’s proposals

MedTech Europe positively assessed measures such as the removal of mandatory five-year renewals for CE certificates, the introduction of risk-based periodic reviews, and the increased digitalisation of technical documentation and conformity declarations. The association also called for stronger international regulatory cooperation, including the EU’s participation in programmes such as the Medical Device Single Audit Program (MDSAP), to improve global competitiveness and support exports. 

The organisation further supported dedicated pathways for breakthrough and orphan technologies, while calling for clearer integration of AI Act requirements into the MDR/IVDR framework through a single conformity assessment process. However, MedTech Europe strongly opposed the possible reuse of single-use devices, arguing that such an approach could undermine patient safety. 

AESGP calls for proportionality for low-risk devices

AESGP, representing the self-care medical device sector, focused primarily on the need for proportionality and legal certainty for low-risk products. The association criticised the proposed extension of conformity assessment scrutiny procedures to all medical devices regardless of risk class, warning that it could create unnecessary administrative burdens without significant safety benefits. 

The organisation also raised concerns regarding the procedures used to determine whether products fall within the scope of the MDR and requested the removal of references to pharmaceutical legislation for substance-based devices. AESGP further advocated extending electronic instructions for use to patients as well as healthcare professionals and supported the introduction of a Class I category for low-risk software, while calling for clarification on rules governing software used in critical clinical situations.

How to address wound care according to MedTech Europe

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How to address wound care according to MedTech Europe

The care of chronic wounds should become a strategic priority for European health policies, according to the latest white paper published by the Wound Care Sector Group of MedTech Europe. The document highlights how chronic wounds are still underestimated despite their growing impact on patients, healthcare professionals, and national healthcare systems across Europe.

Today, approximately 1–2% of the population in high-income countries (around 7 to 14 million people) are affected by chronic wounds, a condition that is often complex and difficult to manage. Diabetic foot ulcers represent one of the most critical examples, with studies showing that they can lead to a five-year mortality rate comparable to that of some forms of cancer. Beyond the clinical implications, the economic burden is also significant, with wound care estimated to account for nearly 4% of total healthcare expenditure.

According to MedTech Europe, chronic wounds should not simply be considered an inevitable long-term condition. The white paper argues that no wound is inherently “chronic”; rather, chronicity is frequently the consequence of insufficient prevention, delayed diagnosis, fragmented care pathways, and limited access to integrated treatment approaches.

A more integrated and patient-centred approach

One of the key messages emerging from the paper is the need for a holistic and evidence-based approach to wound management. MedTech Europe stresses that improving outcomes requires stronger integration of chronic wound care into both European and national healthcare strategies.

This means moving beyond isolated interventions and creating coordinated care pathways capable of supporting patients throughout the entire treatment process. Early intervention, continuity of care, and collaboration between healthcare professionals are identified as essential elements to reduce complications and improve quality of life.

The organisation also underlines the importance of multidisciplinary teams involving clinicians, nurses, specialists, and community healthcare providers. Standardised education and training programmes are considered equally important to ensure more consistent clinical practices and improve treatment efficiency across different healthcare settings.

Digital tools and data-driven decision-making

Another area highlighted in the white paper concerns the growing role of digital technologies in wound care management. According to MedTech Europe, digital tools can support earlier diagnosis, remote monitoring, and more accurate assessment of wound progression, helping healthcare professionals optimise treatment decisions. The document also calls for broader adoption of real-world evidence and data-driven approaches to better inform policy and reimbursement decisions. In parallel, value-based procurement models are seen as an opportunity to encourage innovation while ensuring sustainable healthcare spending.

Among the recommendations included in the paper are also the alignment of reimbursement systems with patients’ needs and income levels, as well as greater investment in prevention programmes capable of reducing the incidence and severity of chronic wounds over time. Overall, MedTech Europe’s position is clear: addressing chronic wounds more effectively will require a systemic transformation involving policy makers, healthcare providers, industry stakeholders, and patients themselves.

EMA issues Q&A guideline on additive manufacturing

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EMA issues Q&A guideline on additive manufacturing

The European Medicines Agency (EMA) has published a new Q&A guideline focused on GMP and quality aspects related to 3D printing in pharmaceutical manufacturing. Released in mid-March, the document applies to human and veterinary medicines as well as investigational products, highlighting the growing role of additive manufacturing technologies in the healthcare sector.

According to EMA, 3D printing — also referred to as additive manufacturing — is an umbrella term covering different techniques used to create solid structures through the sequential deposition of layers of suitable materials. The technology is increasingly being explored for the production of personalised pharmaceutical dosage forms.

Focus on quality-by-design and process validation

Among the main advantages of additive manufacturing, the guideline highlights the possibility of tailoring dosages, combining multiple active ingredients and customising the shape and colour of tablets. These features could improve usability and treatment adherence, particularly for paediatric and geriatric patients.

The EMA document adopts a quality-by-design approach across the entire production cycle. It discusses the selection of the most appropriate printing technology according to the characteristics of the active pharmaceutical ingredient (API), including solubility, degradation profile and biopharmaceutical classification.

The guideline also examines all factors that may affect the final quality of the medicinal product, such as rheological properties, physical state of the API, particle size, compatibility with excipients and stability, including aspects linked to printing temperatures. Additional attention is given to the properties of the so-called “pharmaceutical ink” and to process validation requirements.

Trump’s tariffs after Section 232 probe

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Trump’s tariffs after Section 232 probe

Following the conclusion of the Section 232 investigation launched in August 2025, US President Donald Trump announced on 2 April 2026 a sweeping new tariff policy targeting pharmaceutical imports. The measure introduces a 100% tariff on all imported patented medicines and their related ingredients, marking a significant shift in US trade and industrial strategy in the healthcare sector.

Phased rollout and differentiated rates

The implementation timeline varies by company size. Large pharmaceutical firms will be subject to the new tariffs within 120 days, while smaller companies will have a longer adjustment window of 180 days.

However, the policy includes differentiated treatment for key allied markets. Pharmaceutical products imported from the European Union, Japan, South Korea, Switzerland, and Liechtenstein will be subject to a reduced tariff rate of 15%. Imports from the United Kingdom will face an even lower rate, although the exact percentage has not been specified.

Exemptions and incentives for onshoring

The framework also introduces incentives tied to pricing and manufacturing commitments. Companies that have entered into Most Favoured Nation (MFN) pricing agreements with the Department of Health and Human Services (HHS), and have simultaneously signed onshoring agreements with the Department of Commerce, will benefit from a full exemption from tariffs until 20 January 2029. By contrast, companies that have only signed onshoring agreements will face a reduced tariff rate of 20%.

Notably, certain categories of medicines are currently excluded from the new duties. Generic and biosimilar drugs, along with their associated ingredients, remain fully exempt, although this provision is set to be reviewed in one year. Additional exemptions are предусмотрed for orphan drugs, veterinary medicines, and other specialised medicinal products.

The new tariff regime underscores Washington’s dual objective of strengthening domestic pharmaceutical manufacturing capacity while maintaining strategic trade relationships with selected partners.

Gene and cell therapies, market trends for Q4 2025

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Gene and cell therapies, market trends for Q4 2025

The latest figures on the gene and cell therapy market released by the Alliance for Regenerative Medicine for the fourth quarter of 2025 show a clear lead for the United States over Europe, both in the number of clinical trials (916 vs 337) and in total investments ($2.5 billion vs $0.6 billion), despite a nearly identical number of developers (703 vs 685).

On the regulatory front, the new “plausible mechanism pathway” announced by the FDA at the end of last year is designed to accelerate access to personalized gene editing therapies and other treatments targeting unmet medical needs. Also in the United States, Baby KJ became the first child to receive an in vivo gene editing treatment for the ultra-rare CPS1 deficiency—a condition caused by the lack of the carbamoyl phosphate synthetase 1 enzyme, leading to toxic ammonia accumulation in the body. The CRISPR-based therapy was developed in just six months from diagnosis, with FDA authorization granted in only one week.

In Europe, meanwhile, the publication of the Biotech Act by the European Commission on December 16, 2025, is being seen as a turning point for the biotech medicines sector. The initiative combines financial incentives with regulatory improvements aimed at supporting the development of gene and cell therapies.

European pipelines lag behind

The report also highlights a robust U.S. pipeline, with at least twenty gene and cell therapy products already approved (three in 2026) or nearing regulatory submission.

By contrast, Europe’s clinical pipeline remains significantly smaller, with only five products approaching or having reached approval in 2026. Among them is the gene therapy developed by Fondazione Telethon for Wiskott-Aldrich syndrome, approved by the European Commission on January 16, 2026. The therapy had also received FDA approval in December 2025 and marks a milestone as the first case worldwide of a gene therapy for a rare genetic disease fully developed by a non-profit organization. Two additional approvals are expected in Europe this year, involving a cell therapy for metastatic melanoma and a gene therapy for retinitis pigmentosa.

On the corporate front, the quarter was marked by Bristol Myers Squibb’s $1.5 billion acquisition of Orbital Therapeutics, alongside several new strategic partnerships. Notably, Italy’s Chiesi has entered into a collaboration with Arbor Biotechnologies focused on genome editing for the treatment of primary hyperoxaluria type 1, with an upfront commitment of $115 million from Chiesi.

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