The Impact of Regulation On Drug Development

The impact of regulation on drug development provides the reader with a basic understanding of the evolution of global regulatory standards relevant to the research and development process of medicinal products and the role regulatory science plays, i.e. the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of regulated products.

In light of the high-growth expectations of international investors, the increasing costs of research and development, and the challenges to patent protection, the pharmaceutical industry is in urgent need of substantial improvements in research and development productivity.

The global framework of national legislations, (partly) harmonised guidelines and their evolution provides challenges and opportunities to an efficient management of the R&D process, which should be targeted to receive timely marketing authorisations and viable pricing and reimbursement decisions.

Standard R&D strategies established originally for small molecules have to be intensively reviewed against this regulatory frame. This is particularly true if development projects are derived from biotechnological processes such as recombinant DNA technology, controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells, hybridoma and monoclonal antibody methods or advanced therapy medicinal products such as gene or somatic cell therapy or tissue engineered products.

Scientific (and regulatory) advice provided by health authorities should be considered as a potential value-increasing instrument in order to focus and streamline the R&D process.

This book provides practical guidance on how to obtain such advice efficiently and how it is incorporated in global regulatory planning and strategies.