Lutz M, Moleman T, Leufkens HGM. European science for health research needs and priorities. Eur J Pharm Sci. 2026;223:107570. doi:10.1016/j.ejps.2026.107570

• This EurSci4Health survey maps research priorities among life science researchers - spanning priority diseases, AI integration, basic sciences, drug discovery, development and regulatory sciences.
• Europe’s research funding landscape is changing rapidly in response to advances in science and technology, pressing societal needs, as well as European competitiveness and geopolitical realities.
• There is a growing call to balance top-down strategic initiatives with bottom-up, investigator-driven funding schemes, including greater freedom for researchers to pursue bold, curiosity-driven basic science.

Hellmann, K., Jukes, H., Hofer, M., Peters, J., Schmerold, I., Beechinor, G., Bruno, R., Cooney, R., Braun, G., Cull, Ch., Bergmann, S., Walkenhorst, M., Schlittenlacher, Th., Cvejic, D., Straube, J., Huettinger, C. (2026). Innovation in animal health under Regulation (EU) 2019/6: Review and recommendations. Frontiers in Veterinary Sciences, 13 April 2026, https://www.frontiersin.org/articles/10.3389/fvets.2026.1758179

• The paper reviews the first three years of the EU’s veterinary medicines Regulation 2019/6 and concludes that, while intended to encourage innovation, its implementation has created regulatory uncertainty, higher costs, and barriers—especially for limited-market and novel veterinary medicines.

• Key obstacles include strict eligibility criteria for reduced data requirements, rising regulatory and pharmacovigilance burdens, increased EMA fees, and inconsistent or evolving interpretations of the legislation.

• The authors argue for a more flexible and predictable regulatory system, including easier access to scientific advice, broader use of phased/post-authorization evidence and real-world data, and greater recognition of innovations involving existing technologies and sustainability benefits.

• Overall, they recommend adapting regulatory processes to better balance robust evidence requirements with commercial realities, particularly for small veterinary markets, so that innovative medicines can reach animals while remaining economically viable. (doi.org)

Maclean N, Abrahmsén-Alami S, Clark C, et al. Empowering the pharmaceutical workforce for the digital future. Eur J Pharm Sci. 2026;220:107449. doi:10.1016/j.ejps.2026.107449

• The pharmaceutical industry is rapidly adopting AI, automation, data science, digital twins, and smart manufacturing, transforming drug development and manufacturing.
• A major barrier to digital transformation is the persistent digital and data-science skills gap within the pharmaceutical workforce.
• Traditional separation between pharmaceutical scientists, data scientists, IT specialists, and automation engineers is becoming increasingly unsuitable; cross-disciplinary integration is essential.
• Existing pharmaceutical roles are changing: formulation scientists, analytical chemists, process engineers, and manufacturing professionals increasingly need to work confidently with data and digital tools.
• Future professionals need a combination of pharmaceutical domain expertise, digital literacy, data skills, and transferable skills such as communication and interdisciplinary collaboration.
• Emerging approaches such as Quality by Digital Design (QbDD) integrate modelling, advanced analytics, and digital twins into pharmaceutical product and process development.
• Universities should embed relevant digital and data-science competencies into pharmaceutical science curricula, rather than treating them as separate specialist subjects.
• The existing workforce also requires continuous upskilling and reskilling through flexible, industry-relevant continuing professional development (CPD).
• Skills development should cover the entire career lifecycle, from higher education and vocational training through to lifelong professional learning.
• Academia, the pharmaceutical industry, and policymakers need to collaborate to create an adaptive and interdisciplinary skills ecosystem.
• The paper's central message is that successful pharmaceutical digital transformation depends not only on acquiring new technologies but also on developing people who can effectively understand, integrate, and apply them.

Schug B, Beuerle G, Bilensoy E, et al. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the sixth international EUFEPS/PQRI conference. Eur J Pharm Sci. 2025;212:107129. doi:10.1016/j.ejps.2025.107129

• The article summarizes discussions from the 6th Global Bioequivalence Harmonisation Initiative (GBHI) conference, bringing together experts from academia, industry, and regulatory agencies.
• The overall goal is greater international harmonisation of bioequivalence (BE) requirements, which could make global generic-drug development more consistent and efficient.
• PBPK/PBBM modelling is gaining acceptance as a tool to support generic drug development and potentially justify waivers for certain clinical BE studies.
• However, more evidence is needed before modelling can reliably replace studies for complex formulations and poorly soluble drugs, particularly under fed conditions.
• For narrow therapeutic index drugs, regulators are moving toward greater agreement on variability-based BE criteria, although some methodological differences remain.
• The paper emphasizes the importance of controlling Type I error when applying alternative or scaled BE acceptance approaches.
• It discusses challenges around choosing single-dose versus multiple-dose studies, particularly for modified-release formulations.
• Highly variable drugs remain an important area for harmonisation, especially regarding reference-scaled approaches to BE assessment.
• The conference also addressed BE approaches for orally inhaled drug products, where demonstrating equivalence can require multiple complementary methods.
• Other key topics include partial AUC measures, modified-release products, scaling approaches, and waivers for additional product strengths.
• The central conclusion is that international regulators are making progress toward common BE standards, but important scientific and regulatory differences still need to be resolved.

Blume H, Wedemeyer S, Seidlitz A, Beuerle G, Klein S, Bilensoy E. Open forum conference on the ICH M13A bioequivalence guideline. Eur J Pharm Sci. 2024;196:106741. doi:10.1016/j.ejps.2024.106741

• The article summarizes an EUFEPS Open Discussion Forum on the draft ICH M13A guideline for bioequivalence (BE) studies of immediate-release oral solid dosage forms.
• The forum brought together scientists from academia, industry, and members of the ICH M13A drafting group to discuss potentially controversial regulatory requirements.
• One key topic was the selection of study participants, particularly whether both female and male participants need to be included in BE trials.
• The participants discussed when BE studies should be conducted under fasted conditions, fed conditions, or both, with arguments for avoiding unnecessary studies.
• The paper considers how differences in active ingredient content (potency) between test and reference products can influence BE results and whether potency correction should be applied.
• Another issue is the treatment of aberrant or unusual plasma concentration profiles, which can substantially affect pharmacokinetic analysis and BE conclusions.
• Special attention is given to drugs with pH-dependent solubility, where differences in gastrointestinal pH may influence drug absorption and complicate BE assessment.
• The discussions identified several areas where the proposed requirements could benefit from greater scientific justification, clarification, or revision.
• The broader objective of ICH M13A is to achieve greater international harmonisation of bioequivalence requirements, reducing differences between regulatory regions.
• The paper's central message is that harmonisation is valuable, but BE guidelines should remain scientifically justified and sufficiently flexible to account for differences between drugs and formulations.

Schmerold I., van Geijlswijk, I., Gehring, R. 2023. European regulations on the use of antibiotics in veterinary medicine. European Journal of Pharmaceutical Sciences, 2023, https://doi.org/10.1016/j.ejps.2023.106473

• The article reviews European Union regulations governing antibiotic use in animals, with a particular focus on protecting both animal and public health.
• A central concern is antimicrobial resistance (AMR), which has driven stricter rules on how antibiotics can be prescribed and administered in veterinary medicine.
• The paper discusses Regulation (EU) 2019/6, which introduced important restrictions intended to promote the responsible and prudent use of veterinary antimicrobials.
• Routine and prophylactic use of antibiotics is restricted, while metaphylactic use is permitted only under specific conditions when the risk of infection is sufficiently high.
• Certain antimicrobial substances may be reserved for treating infections in humans, limiting or preventing their veterinary use to preserve their effectiveness.
• Veterinarians must follow specific rules when prescribing antibiotics, including limitations on off-label use and the prescribing cascade.
• The regulations distinguish between food-producing and non-food-producing animals, particularly because antibiotic use in food animals must also consider drug residues and consumer safety.
• For food-producing animals, maximum residue limits and withdrawal periods are important to prevent unacceptable antibiotic residues from entering the food chain.
• The article highlights the challenge of balancing access to effective treatments for animals with the need to reduce unnecessary antimicrobial use.
• Overall, the new European regulatory framework supports a One Health approach, recognizing the close relationship between antimicrobial use in animals, antimicrobial resistance, and human health.
• The central message is that responsible antibiotic use, appropriate regulation, and surveillance are essential for preserving antimicrobial effectiveness while maintaining animal welfare.

Gehring, R., Mochel, J.P., Schmerold, I. 2023. Understanding the Background and Clinical Significance of the WHO, WOAH and EMA Classifications of Antimicrobials to Mitigate Antimicrobial Resistance. Frontiers in Veterinary Science, 2023, https://doi10.3389/fvets.2023.1153048

• The article compares three major systems for classifying antimicrobials: those of the WHO, WOAH, and EMA.
• All three systems aim to promote responsible antimicrobial use and help reduce the development and spread of antimicrobial resistance (AMR).
• The WHO classification primarily considers the importance of antimicrobials for human medicine, including the risk of resistance transmission from animals and other non-human sources.
• The WOAH classification focuses on the importance of antimicrobials for veterinary medicine, specifically in food-producing animals.
• The EMA classification provides practical guidance on antibiotic use in animals, grouping antibiotics into categories A (Avoid), B (Restrict), C (Caution), and D (Prudence).
• Although the three systems have similar overall goals, they use different criteria and perspectives, meaning the same antimicrobial can receive different classifications.
• The article discusses these differences using examples including amoxicillins without beta-lactamase inhibitors, macrolides, sulfonamides, and colistin.
• Differences in classification do not necessarily represent contradictions; they often reflect whether the system prioritizes human-health risks or veterinary treatment needs.
• Veterinarians should therefore understand the purpose and context of each classification system rather than directly comparing category labels.
• For everyday veterinary clinical decisions in Europe, the authors recommend primarily following the EMA classification, with the WOAH list providing additional guidance in uncertain situations.
• The central message is that appropriate antimicrobial selection requires balancing effective treatment of animals with the preservation of important antibiotics, supporting a broader One Health approach to combating AMR.

Blume H., Mehta M., Beuerle G., et al. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference. Eur J Pharm Sci. 2021;167:105987. doi:10.1016/j.ejps.2021.105987

• The paper summarizes discussions from the 4th GBHI conference, which aimed to promote greater international harmonisation of bioequivalence (BE) requirements.
• The conference brought together experts from regulatory agencies, academia, and the pharmaceutical industry.
• A major topic was the assessment of complex drug products, for which conventional pharmacokinetic BE studies may not always be sufficient.
• The paper discusses the growing role of in-vitro methods, modelling, and simulation in supporting or potentially replacing certain in-vivo BE studies.
• Physiologically based pharmacokinetic and biopharmaceutics modelling can help predict drug performance and support regulatory decision-making.
• The conference considered challenges associated with long-acting injectable products, where complex release mechanisms make demonstrating equivalence particularly difficult.
• Orally inhaled drug products were also discussed because their local delivery to the lungs creates additional challenges for establishing BE.
• The paper highlights the importance of developing sensitive and clinically relevant methods for assessing equivalence of locally acting and complex products.
• Greater use of advanced analytical and computational approaches could reduce unnecessary human studies while maintaining confidence in product equivalence.
• Differences between regulatory regions remain an obstacle to efficient global generic-drug development, emphasizing the need for continued scientific dialogue and harmonisation.
• Overall, the article argues that modern, science-based BE approaches should complement traditional clinical studies and support more consistent global regulatory standards

Mehta M, Blume H, Beuerle G, et al. The global bioequivalence harmonisation initiative: Report of EUFEPS/AAPS third conference. Eur J Pharm Sci. 2020;151:105383. doi:10.1016/j.ejps.2020.105383

• The article summarizes the 3rd Global Bioequivalence Harmonisation Initiative (GBHI) conference, held in Amsterdam in 2018.
• The initiative brings together experts from regulatory agencies, academia, and the pharmaceutical industry to promote global harmonisation of bioequivalence (BE) requirements.
• The conference focused on three main topics: multiple-dose BE studies, transdermal delivery systems, and liposomal parenteral products.
• Participants discussed whether multiple-dose studies are necessary for demonstrating BE, particularly when adequately designed single-dose studies may be more sensitive.
• Reducing unnecessary multiple-dose studies could simplify generic-drug development while avoiding unnecessary exposure of study participants.
• For transdermal drug delivery systems, demonstrating equivalence requires consideration of drug delivery as well as product characteristics such as adhesion, irritation, and sensitisation.
• Differences between regulatory regions in the evaluation of transdermal products highlight the need for more internationally consistent requirements.
• Liposomal parenteral products are particularly challenging because their complex formulation can strongly influence drug distribution, release, pharmacokinetics, and clinical performance.
• Demonstrating equivalence of liposomal products may therefore require a weight-of-evidence approach, combining detailed physicochemical characterization with nonclinical and clinical evidence.
• The article emphasizes that harmonisation should be based on scientific evidence and product-specific considerations, rather than applying identical requirements to every drug product.
• Overall, the conference identified opportunities to reduce unnecessary studies while maintaining confidence in product quality, safety, and therapeutic equivalence.

Chen ML, Blume H, Beuerle G, et al. Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence. Eur J Pharm Sci. 2019;127:24-28. doi:10.1016/j.ejps.2018.10.019

• The article summarizes discussions from the 2nd EUFEPS/AAPS conference focused on achieving greater international harmonisation of bioequivalence (BE) requirements.
• The conference brought together experts from regulatory agencies, academia, and the pharmaceutical industry to identify differences between regional BE guidelines.
• A major topic was the use of biowaivers, which can allow approval without an in-vivo BE study when sufficient evidence from drug properties and in-vitro testing is available.
• The paper discusses the Biopharmaceutics Classification System (BCS) and differences between regulatory authorities in applying BCS-based biowaivers.
• Highly variable drugs and drug products were another key area, particularly the use of reference-scaled approaches to avoid unnecessarily large BE studies.
• The participants considered how narrow therapeutic index drugs should be evaluated and whether tighter BE acceptance limits are necessary.
• The conference also addressed the appropriate selection of study design, study conditions, and pharmacokinetic endpoints for demonstrating BE.
• Differences in regulatory requirements can lead to duplicate BE studies when the same generic product is developed for multiple international markets.
• Greater harmonisation could therefore reduce unnecessary human studies, lower development costs, and improve the efficiency of global generic-drug development.
• The paper emphasizes that harmonisation should be based on sound scientific principles while maintaining confidence in the quality, safety, and efficacy of generic medicines.
• Overall, the conference identified substantial opportunities for greater global alignment, while highlighting areas where further scientific discussion and regulatory consensus are needed.

Mochel, J.P., Tyden, E., Hellmann, K., Vendrig, J.C., Şenel, S., Dencker, L., Cristina, R.T., Linden, H., Schmerold, I (2018). Network on Veterinary Medicines initiated by the European Federation for Pharmaceuti­cal Sciences. Journal of Veterinary Pharmacology and Therapeutics, 2018; 41, 378-383. https://doi.org/10.1111/jvp.12472

• The article introduces a dedicated Network on Veterinary Medicines established within the European Federation for Pharmaceutical Sciences (EUFEPS).
• EUFEPS brings together academic, industrial, and regulatory scientists working in pharmaceutical research, development, regulation, and education across Europe.
• The veterinary medicines network was created in response to the complex challenges associated with veterinary drug development and use.
• A central theme is the strong connection between veterinary medicines and human health, public health, and environmental health.
• The network aims to strengthen collaboration and knowledge exchange among scientists, veterinarians, pharmaceutical companies, and regulatory authorities.
• It seeks to address scientific and regulatory challenges that can limit the availability and development of medicines specifically designed for animals.
• One long-term objective is to expand the range of therapeutic options available in veterinary medicine.
• The initiative also encourages research into innovative drug-delivery systems adapted to the specific needs of different animal species.
• International cooperation is considered important because challenges surrounding veterinary medicines extend beyond individual countries and disciplines.
• Overall, the paper presents the network as a platform for advancing veterinary pharmaceutical sciences through multidisciplinary and international collaboration.
• The broader goal is to improve animal therapeutics while recognizing their interconnected implications for animal, human, and environmental health.

Chen ML, Blume H, Beuerle G, et al. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference. Eur J Pharm Sci. 2018;111:153-157. doi:10.1016/j.ejps.2017.09.047

• The article reports on the first Global Bioequivalence Harmonization Initiative (GBHI) conference, which aimed to promote international alignment of bioequivalence (BE) requirements.
• Experts from regulatory agencies, academia, and the pharmaceutical industry participated in discussions on differences between global BE standards.
• The initiative recognizes that differing national and regional requirements can lead to duplicate BE studies, increasing development time, costs, and unnecessary human participation.
• A major objective is to establish common scientific principles that could support globally acceptable BE studies.
• The discussions addressed differences in study design and conduct, including selection of study populations and appropriate experimental conditions.
• The conference considered the appropriate pharmacokinetic parameters and acceptance criteria used to determine BE.
• Highly variable drugs were highlighted as an area where different regulatory approaches can result in substantially different study requirements.
• The participants also discussed narrow therapeutic index drugs, for which some authorities apply tighter BE acceptance criteria.
• BCS-based biowaivers were identified as another important opportunity for international harmonisation and for reducing unnecessary in-vivo studies.
• Greater regulatory convergence could allow a single BE development programme to support generic-drug applications across multiple regions.
• Overall, the paper establishes the foundation for the subsequent GBHI conferences you summarized above, emphasizing continued international scientific dialogue to achieve more consistent, efficient, and scientifically justified global BE standards

L. Dencker, K. Hellmann, J. Mochel, S. Şenel, E. Tyden, J.C. Vendrig, H. Linden, I. Schmerold (2016). Position Paper: EUFEPS Network on Veterinary Medicines Initiative: An interdisciplinary forum to support Veterinary Pharmacology and promote the development of new pharmaceuticals for Animal Health. European Journal of Pharmaceutical Sciences 91 (2016) I–VII 

• The paper introduces the EUFEPS Network on Veterinary Medicines, created to strengthen collaboration in veterinary pharmaceutical sciences.
• Veterinary medicines are important not only for animal health and welfare, but also for food security, public health, and environmental protection.
• The initiative is strongly based on the One Health concept, recognizing the interconnected health of humans, animals, and the environment.
• Important challenges include zoonotic and foodborne diseases, as well as resistance to antibiotics and antiparasitic drugs.
• Medicines used in food-producing animals require particular attention because drug residues may occur in meat, milk, eggs, and other animal-derived foods.
• The spread of antimicrobial-resistant microorganisms between animals, humans, and the environment is identified as a major global concern.
• Developing veterinary medicines is particularly complex because of the large number of animal species, husbandry systems, diseases, and species-specific treatment requirements.
• The network aims to encourage the development of innovative veterinary pharmaceuticals and advanced drug-delivery systems.
• An interdisciplinary approach is needed to evaluate the benefit–risk profiles of new veterinary medicines and technologies.
• The initiative seeks to connect expertise from areas including pharmacology, biopharmaceutics, pharmacogenomics, safety sciences, nanomedicine, environmental sciences, and regulatory science.
• Improving education and professional training for veterinarians, pharmaceutical scientists, and specialists in veterinary drug formulation is another major objective.
• The network also aims to strengthen academic research, stimulate international research collaborations, and support applications for European research funding.
• Overall, the paper presents the EUFEPS network as a platform for bringing together academia, industry, regulators, and other stakeholders to address unmet needs and expand the availability of safe and effective medicines for animals.