European Regulatory Affairs Network and Industry agree on need for better regulation agenda
‘Getting rid of the paper’ was one topic discussed by Lars Olsen, Executive Vice President – Research and Development at Leo Pharma in the Opening Session of the TOPRA Annual Symposium in Copenhagen.
His point was simple—regulators and legislators must take steps to reduce the burden on industry using innovations such as electronic Common Technical Document (eCTD). Tools like this are available and the willingness is there, but National Agencies and European bodies are, in most cases, not geared up to accept innovations like this yet. In Leo’s case they were able to file the electronic application for marketing authorisation in only 3 countries. In the others, the company was forced to print 600,000 pieces of paper which were filed into 1673 binders. While it is an ambition to meet the 2009 deadline for all Member States to accept eCTD, it is clear that this will be a considerable challenge both technically and financially.
As a key driver of change, the European Commission is taking the better regulation agenda seriously according to DG Enterprise and Industry Head of Unit (F2), Martin Terberger. As a testament to this, the Commission is unlikely to bring forward any major new legislative proposals in next couple of years. Instead, they are focused on evaluating the progress of implementation and filling gaps in the existing framework. One area where legal action is likely in 2008 is in the area of European Regulations concerning variations. Companies can expect simplifications and a reduction of administrative burdens. Furthermore, based upon feedback from stakeholder and industry, officials are taking the even bolder step of trying to harmonise national legislation on variations. However, this will first require the establishment of a legal basis for them to do so and is a longer-term objective.
Furthermore, Terberger stated that as of now, the Commission is not inclined to act on issues like excipients because there major implications for industry and the benefits are unclear.
However many of the delegates at the Annual Symposium agree, there’s much more to be done to answer the challenge between now and 2010.
For more information, please contact:
Jacob Coy // Cicero Consulting // 0207 665 9530
