Japan Speeds Up Drug and Device Review Process
Posted 05 December 2011 | By
Japan's Pharmaceuticals & Medical Device Agency (PMDA) has continued to take steps to speed up its review process for new medical devices and pharmaceuticals. Since 2009, the PMDA has actively worked at shortening the timeline between clinical trials and approval. A number of these changes were recently initiated. A key component of the plan is the full introduction of the "prior assessment consultation system" in 2011. This system shortens the review period by allowing submittal of data on quality, toxicity, Phase I & II results, etc. for initial assessment during the Phase III clinical trial period. In addition, a new service introduced in mid-2011 allows companies to seek "regulatory strategy consultation" from PMDA staff and experts. Applicants receive guidance early on in a product's R&D on the procedures and clinical trials that will be required for approval. This service is offered in the areas of regenerative medicine, cancer, refractory and orphan diseases, pediatric care, and products using innovative technologies. The PMDA will continue to implement reforms in 2012 to reduce Japan's "drug and medical device lag" behind global markets.