Nostrapharmus considers how the industry can continue effective global trials and align with a simpler future regulatory landscape
Globalisation of clinical research has presented both opportunities and challenges to the pharmaceutical industry. The logistical challenges of global operations have driven the industry to advocate for consistency and for a reduction in bureaucracy for conducting multinational trials. New initiatives in EU, US, and BRIC (Brazil, Russia, India, and China) countries indicate a move towards simplification, harmonisation and transparency; but despite the best intentions of these initiatives, the immediate future remains complex. So, Nostrapharmus asks: "How can we continue effective global trials and align with a (hopefully) simpler future regulatory landscape?"
As Europe continues to struggle with escalating costs, slow recruitment into trials and the threat from emerging market competitors, a pragmatic update to the EU legislation is much needed. The proposed revision of the Clinical Trials Directive 2001/20/EC aims to harmonise the application for authorisation, with all member states indicating a strong trend towards a single submission process with a co-ordinated assessment procedure. The Commission states that to achieve greater harmonisation and risk-adaptation on the content of the application dossier, "sufficiently detailed provisions could be included in the Annexes to the basic legal act."1 Although some form of harmonisation is expected, the elements that would be required by the 'harmonised' clinical trial authorisation application remain unclear. The 'revision' is also set to address the classification of investigational and non-investigational medicinal products, sponsorship of clinical trials across EU, emergency clinical trials, and clinical trials performed in third countries. The Commission received 143 responses from stakeholders across the board - there is general consensus with finding a solution to the impediments caused by the EU legislations. It will be interesting to see whether the Commission will hold any further consultation ahead of the proposed legislative changes in 2012.
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