In a journal that is effectively dedicated towards the discovery of novel and ingenious drug candidates, we can become obsessed with this. As a result, we can lose sight of the fact that the job isn’t done until your new drug candidate enters the market. That often includes the regulatory aspects of drug discovery – an essential process to ensure that you get a return on investment for the 10 or so years you have spent fine tuning the efficacy and bioavailability and ruling out toxicological aspects of your drug entity. Hopefully this newsletter will give some food for thought as we cover some of the articles that have appeared in Drug Discovery Today in the last 18 months or so, that deal with the suitability of the current regulatory framework in Europe, the transparency of the systems in Europe and Australia and how databases, such as FDALabel, may facilitate enhanced precision medicine, drug safety and regulatory science.

The first article in this month’s offering is entitled: “Is the European regulatory framework sufficient to assure the safety of citizens using health products containing nanomaterials?”, by Umberto M. Musazzi, Valentina Marini, Antonella Casiraghi and Paola Minghetti of the Department of Pharmaceutical Sciences, Università degli Studi di Milano, Milan, Italy. In this article, the authors examine the stratified regulatory framework concerning the use of nanomaterials in healthcare products intended to be marketed in the European Economic Area and highlight the current criticisms associated with the framework.

The second featured article is by Peter Papathanasiou, Laurent Brassart, Paul Blake, Anna Hart, Lel Whitbread, Richard Pembrey and Jill Kieffer of Therapeutic Goods Administration, Regulatory Services Group, Department of Health, Australia and the European Medicines Agency, London, UK. It is entitled: “Transparency in drug regulation: public assessment reports in Europe and Australia”. In this article, the authors discuss the value and importance of transparency and openness for regulatory agencies. They discuss the ways in which the 2 organisations (the TGA and the EMA) report their findings to the public – those reasons underpinning why particular compounds have been successful or otherwise. Currently, this information is conveyed using reports: European Public Assessment Reports (EPARs) in Europe and Australian Public Assessment Reports (AusPARs) in Australia. These reports summarise the safety, efficacy and quality of the submitted compounds. They give their combined opinions on this process and speculate how such information may be transmitted, now and in the future.

The final article in this month’s offering is: “FDA drug labeling: rich resources to facilitate precision medicine, drug safety, and regulatory science” from Hong Fang, Stephen C. Harris, Zhichao Liu, Guangxu Zhou, Guoping Zhang, Joshua Xu, Lilliam Rosario, Paul C. Howard and Weida Tong from the National Center for Toxicological Research and the Office of Computational Science, Center for Drug Evaluation and Research, US Food and Drug Administration, MD, USA. In this article, they describe how they have condensed and collated decades of experience with respect to drug labelling, which contains detailed information of drugs, drug-drug interactions and adverse drug reactions. This data has been used to develop a database, entitled FDALabel, to facilitate navigation through this sea of data. At the time of writing, this database had in the region of 80,000 labels of compounds. With its full-text search capability, the database can be used for a variety of applications, some of which are illustrated within.

Steve Carney was born in Liverpool, England and studied Biochemistry at Liverpool University, obtaining a BSc.(Hons) and then read for a PhD on the Biochemistry and Pathology of Connective Tissue Diseases in Manchester University, in the Departments of Medical Biochemistry and Histopathology. On completion of his PhD he moved to the Kennedy Institute of Rheumatology, London, where he worked with Professor Helen Muir FRS and Professor Tim Hardingham, on the biochemistry of experimental Osteoarthritis. He joined Eli Lilly and Co. and held a number of positions in Biology R&D, initially in the Connective Tissue Department, but latterly in the Neuroscience Department. He left Lilly to take up his present position as Managing Editor, Drug Discovery Today, at Elsevier. Currently, he also holds an honorary lectureship in Drug Discovery at the University of Surrey, UK. He has authored over 50 articles in peer-reviewed journals, written several book chapters and has held a number of patents.