Bernd Rosenkranz ^1,2,3* Tomoya Tachi ⁴ Andrei Mocan ⁵ Rolf Bass ²

• ¹ Medicine - Pharmacology, Fundisa African Academy of Medicines Development, Cape Town, South Africa
• ² Charité University Medicine Berlin, Berlin, Baden-Wurttemberg, Germany
• ³ Division of Clinical Pharmacology, Faculty of Medicine and Health Sciences, University of Stellenbosch, Cape Town, South Africa
• ⁴ Department of Clinical Pharmacy, Graduate School of Pharmaceutical Sciences, Nagoya City University, Nagoya, Japan
• ⁵ Faculty of Pharmacy, University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania

The effectiveness of medical treatments and other interventions are assessed to optimize outcomes and health care delivery to enable clinicians, patients, healthcare providers and managers, funders, policy makers and government to make informed decisions (Rosenkranz, 2024). The development and regulatory review of novel (better) medicines that are safe, effective and of good quality have thus become increasingly complex over the past decades, with the establishment of new technologies and concepts and the interdisciplinary and global nature of the pharmaceutical industry.The need for effective capacity strengthening in medicines development and regulation has been recognised worldwide, both in first-world as well as developing and low-and middle-income countries (ESSENCE on Health Research and CCR, 2023). Educational and training programs have been developed by Universities or other organisations (for example: Semete-Makokotlela et al, 2021;Najjemba et al, 2023;Kerpel-Fronius et al. 2015). This Research Topic provides an overview of some of these initiatives, their opportunities and challenges. The development and regulatory approval of medicines for paediatric use requires special attention (Lehmann, 2024). For many medicinal products, only a limited amount of data exist on their safety and efficacy in children. This leads to the dilemma of finding a balance between protecting children and adolescents and obtaining reliable, robust and justified data to treat them adequately and not in an off-label manner with unknown risks. Education and training of all involved stakeholders is important, including healthcare professionals, industry, regulators, and legislators, but also patients and caretakers. Regulatory requirements should be harmonised. A specific example of a significant global health condition is urothelial carcinoma (Romero Clara, 2024).Healthcare professionals who deal with bladder cancer patients need comprehensive training to incorporate the advances in healthcare into their clinical practice. The manuscript describes a dedicated educational program to educate healthcare professionals on bladder cancer management and on recent immunotherapy treatment options. This initiative resulted in substantial knowledge enhancement. Complementary initiatives brought together patients and medical experts to foster a holistic, patient-centered approach. The programme has been successfully endorsed by regulatory bodies and professional associations.Novel methodologies such as such as flipped classrooms and problem-based learning are used to improve student engagement and success. The introduction of a blended learning approach can lead to lower failure rates, increased student engagement, and better understanding of complex clinical pharmacology topics as demonstrated in a nursing pharmacology course in Israel (Arien-Zakay, 2024).Training of healthcare professionals by pharmaceutical companies can result in the dissemination of biased information. An online survey amongst pharmacy students in Pakistan revealed that a significant number of them observed that promotional activities have an impact on dispensing practices and for example can contribute to irrational antibiotic prescribing (Gillani et al., 2024). This project underscores the need for industry-independent professional education of healthcare students and professionals.Finally, there has been a suggestion to introduce a training programme on basic aspects of medicines development and regulation for Chief Executive Officers and senior management of pharmaceutical companies and related organisations to assist them in their decision making (Kramer et al., 2024).In conclusion, the publications assembled in this Research Topic clearly demonstrate the need for structured capacity building in medicines development and regulation using a well-designed syllabus, adequate methodologies, assessments and quality control. Gillani AH, Arshad H, Arshed M, Jairoun A, Shukar S, Akbar J, Hussain AK, Malik HMA, Ibrahim