Updated on 6 February 2013
Taking into consideration new science and technology, Singapore plans to erect adaptive, robust and cost efficient regulatory model for drug approval. One-of-the non-conventional models for drug approval is adaptive licensing. Singapore has partnered with bioscience centre of MIT to catalyze innovation in pharmaceutical drug development paradigm and implement adaptive licensing approach. Singapore has committed S$16.1 billion in healthcare sector between 2011-15 out of which S$3.7 billion is dedicated to enhancing research and development.
As published in international scientific journal Nature, traditional drug licensing approaches are based on binary decisions. At the moment of licensing, an experimental therapy is presumptively transformed into a fully vetted, safe, efficacious therapy. By contrast, adaptive licensing (AL) approaches are based on stepwise learning under conditions of acknowledged uncertainty, with iterative phases of data gathering and regulatory evaluation. This approach allows approval to align more closely with patient needs for timely access to new technologies and for data to inform medical decisions.
"This approach allows careful analysis of decision to be taken for patients. From Singapore perspective, new medicine can play a key role in treating diseases with unmet needs. We are still looking at pilot platform to conduct the project for non serious diseases," commented Associate Prof John Lim, CEO, Health Science Authority, Singapore.
In the current landscape, genomics and proteomics, are being allowed to work together, however, undefined regulatory framework and consequent restrictions hinders the clinical application. "In addition to conventional pharmacovigilance, innovative approaches towards more personalized and stratified medicine hold the key to prospectively reduce adverse drug reaction which is possible through collaboration among the industry, academia and regulators to transform clinical application, Prof Lim said.
To come up with rapid advances in emerging sciences, Singapore has hiked deployments in R&D and is now catering to pressing need of cutting edge regulatory expertise. "Regulatory framework must be robust enough to cater to the pace of new drug development and ensure that regulation facilitate safe deployment of latest science. This has to be achieved without impeding new drug development and access because of traditional or outdated regulatory framework," said Prof. Lim.