Japan’s Pharmaceuticals & Medical Device Agency (PMDA) has continued to take steps to speed up its review process for new medical devices and pharmaceuticals. Japan is often far slower than places such as the US and the EU in approving medical devices to market. 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. This occurs prior to formally submitting the new drug application (NDA). The system aids in early identification of problems, which helps companies prepare acceptable NDA dossiers more easily.
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. As of November 2011, PMDA has already received 67 interview applications for strategy consultations.
The PMDA will continue to implement reforms in 2012 to reduce Japan’s “drug and medical device lag” behind global markets. In October 2011, the Ministry of Health, Labor and Welfare (MHLW) Council proposed a bill to amend the Pharmaceutical Affairs Law. It will provide regulatory incentives for companies to invest in the R&D of drugs with high unmet needs, such as granting preferential review status to the companies’ other products. The PMDA has also been working to increase its regulatory workforce to speed the review process. In 2012, the PMDA will continue training potential employees through leading medical graduate schools.