Data and market exclusivity in pharmaceuticals
A look at the current scope and application of regulatory data protection and related market exclusivity rights.
CE mark approval for medical devices – an overview
Colin McCall looks at the main steps that a medical device manufacturer/importer must take in order to obtain CE marking for a product.
FDA and EMA Clusters
Amanda Rowell looks at various forms of collaboration between different medicines' regulators.
New active substances and global marketing authorisations
Ed Vickers and Paul England talk about data and marketing exclusivity for line extensions. More 
Adaptive licensing: a model approach?
Amanda Rowell explains the process of staggered approval of a medicine based on a prospectively-planned process, known as adaptive licensing. More
Health claims
Dr Manja Epping provides a European perspective on how 'health claims' are regulated. More
EU Commission regulates post-authorisation efficacy studies
This article looks at Post-Authorisation Efficacy Studies and their impact in the medical sector. More
Personalised Medicine – challenges of authorisation and reimbursement
Manja Epping & Christina Berchtold discuss the topic from an authorisation and reimbursement perspective. More
Paediatric extensions to SPCs
Ed Vickers explains how compliance with an agreed paediatric investigation plan (PIP) will afford a six month extension to SPC protection on the relevant drug.
Health technology assessments & pharmaceutical pricing
Dr Wolfgang Rehmann & Diana Heimhalt outline the current discrepancies. More
Why do we need data protection policies?
Most organisations will need a number of data protection policies to achieve compliance.
The 'sunset clause' for marketing authorisations
Christopher Thornham explains the application of the 'sunset clause' to marketing authorisations for products.
Regulatory compliance
The life sciences sector is characterised by its high level of regulation. At least a basic understanding of this complex regulatory environment is essential for any business operating the sector, and this section aims to provide an overview of the regulatory regime for both medicines and medical devices.