Bridging regulatory science and innovation for dermal generics and advanced skin therapies
Skin diseases affect 900 million people worldwide and impose major physical, psychological, social and emotional burdens, making cutaneous drug products essential to public health. guideSkin is an Industrial Doctorate training 15 doctoral candidates to transform the development, evaluation and regulatory approval of cutaneous drug products in line with the new EMA Guideline on Quality and Equivalence of Cutaneous Products (effective 2025). The guideline enables bioequivalence-based approval of dermal generics but requires advanced analytical and in vitro methods that many companies and regulators are not yet equipped to apply, causing delays in market entry, reduced innovation and a shortage of specialists able to interpret complex formulation and skin-interaction data.
guideSkin brings together six European universities with key pharma manufacturers and technology-driven industry and SMEs. We will develop a practical, science-based framework for formulation characterisation; advance key permeation-kinetics methods incl. confocal Raman spectroscopy (CRS), physiologically based pharmacokinetic (PBPK) modelling and AI-enabled prediction; and establish quality-evaluation strategies for innovative products such as microneedle array patches (MAPs) and nano-enabled formulations.
Through long-term industrial secondments, interdisciplinary coursework, transferable-skills training and hands-on work in advanced facilities, DCs will gain expertise spanning pharmaceutical technology, spectroscopy, modelling, data and regulatory science. We will deliver validated test protocols, decision trees and computational tools that support regulatory submissions and efficient product development.
guideSkin will strengthen Europe’s innovation capacity and enable faster approval of high-quality dermal medicines and generics. Our graduates will be highly employable specialists able to shape future regulatory frameworks and drive competitiveness in Europe’s pharma and skin-health sectors. This project is currently in grant preparation with the European Commission and set to start on 1 October 2026.
This project is currently in grant preparation with the European Commission.
This project contributes to the UN Sustainable Development Goals (SDGs) 4, 9 and 12.
Eberhard Karls University of Tübingen, DE
Partners:
- University of Surrey, UK
- University College Cork, IE
- University of Belgrade, SRB
- University Paris-Saclay, FR
- Universidade de Lisboa, PT
- Arbeitsgemeinschaft fuer Pharmazeutische Verfahrenstechnik e.V., DE
- Dermapharm AG, DE
- ESQlabs GmbH, DE
- Galenika a.d., SRB
- LTS Lohmann Therapie-Systeme AG, DE
- GIE LVMH Recherche, FR
- Phardevelopment Trials Lda., PT
- SGS Proderm GmbH, DE
- RaDes GmbH, DE
- RiverD International B.V., NL
- Tiofarma BV, NL
- Unilever UK Central Resources Ltd, UK
- accelopment Schweiz AG, CH
