Event Information

Time：April 21, 2015 (Tuesday)
Place ：TRPMA Conference Room

TRPMA invited Mr. Chia-Fong Lu, an attorney specialising in pharmaceutical regulations in the US, the EU and Japan, to provide an insightful analysis of the new review mechanism implemented in the US, the EU and Japan, as well as the application strategies.

In order to expedite and encourage the development of new drugs for unmet medical needs, the US announced the Breakthrough Therapy Designation (BTD) in 2012. This move was followed by the EU and Japan in 2014 as the Adaptive Pathway and Strategy SAKIGAKE were announced in the EU and Japan respectively. As expedited review mechanism has become a worldwide trend, Mr. Lu pointed out that drug companies should facilitate a strategy suitable for their companies’ situations. In order to reduce regulatory uncertainties, drug companies should facilitate strategies for interacting with regulatory agencies, solving the problems in scaling-up the production, introducing personalized medicine, forming effective marketing strategies, managing drug product life cycle, etc.

Mr. Lu explained that international drug manufacturers have modified their licensing models. Now the search for potential products focuses on products at early development stage rather than those having completed Phase II trials. This new model enables drug companies to have an early start in formulating regulatory strategies and gain maximum benefits.