Publications

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

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

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

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

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

Mehta M, Schug B, Blume HH, et al. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference. Eur J Pharm Sci. 2023;190:106566. doi:10.1016/j.ejps.2023.106566

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

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

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

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

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

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

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

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

Chen ML, Shah VP, Crommelin DJ, et al. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report. Eur J Pharm Sci. 2011;44(4):506-513. doi:10.1016/j.ejps.2011.09.010

European science for health research needs and priorities (2026)

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.

Innovation in animal health under Regulation (EU) 2019/6: Review and recommendations (2026)

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)