Article originally published in the Food and Drug Law Journal (with permission from FDLI), August 2008

I. INTRODUCTION

Pharmacovigilance is a global public health activity that is currently undergoing a considerable amount of regulatory, social and political change. The standards expected by society have been raised following high-profile product withdrawals. Industry, regulatory authorities and consumers are now focusing on a more proactive, risk management based approach to drug safety monitoring. There has been a shift from the formulaic collection, classification and reporting of adverse event reports to a more holistic focus on any information suggesting a change in a product’s risk benefit profile.

There has also been a realization that effective pharmacovigilance must be global. Companies and regulatory authorities must receive and react to information suggesting a change in risk-benefit profile wherever it arises. The past 20 years has therefore seen a steady drive towards global harmonization of safety reporting definitions and standards.
Continue Reading Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safety

 Article originally published in RAJ Pharma in July 2008

By 2015 nanotechnology-based medicines and medical devices are expected to flood the global market. Brian Kelly and Peter Bogaert discuss the regulatory and legal implications of medical nanotechnology in Europe.

Nanotechnologies are the design, characterisation, production and application of structures, devices and systems by controlling shape

Article originally published in EURALex, issue 192, in March 2008

The European Commission has launched a consultation on proposed amendments to strengthen and rationalise the European Community (EC) pharmacovigilance rules and systems established by Directive 2001/83/EC and Regulation (EC) No 726/2004. Comments were sought from stakeholders by 1 February 2008. Grant Castle and Robin Blaney