Japan Eyes More Global Efforts; Updates MD/IVD Progress

For those manufacturers and other stakeholders wanting more information in English from Japan’s Pharmaceuticals and Medical Devices Agency, your wait may soon be over.

Hideyuki Kondo, deputy director of the Medical Device and Regenerative Medicine Product Evaluation Division at Japan’s Ministry of Health, Labor and Welfare, said this effort goes hand in hand with the establishment of international and regulatory harmonization strategies by MHLW and the Pharmaceuticals and Medical Devices Agency.

“If we do only domestic things, we cannot advance,” said Toshiyoshi Tominaga, associate executive director at PMDA. He made those comments during a session at the Regulatory Affairs Professional Society Convergence Conference in Baltimore, Md., last week that included members of the health authorities and industry.

The session provided the audience with updates on a number of initiatives by the Japanese health authorities. In particular, regulators are looking to step up cooperative activities through its International Strategic Plan, unveiled in June. That plan defines activities to take place through fiscal year 2023.

“PMDA will strive to implement the strategic plan in order to maximize the health benefits to Japan and the world, by effectively utilizing its human resources, scientific knowledge, electronic information and by other means,” according to the plan.

To that end, PMDA is eyeing an Asian training program to help reviewers understand Japanese device regulations. Tominaga named Bangkok and Singapore as potential sites. Also, Japan recently joined the Medical Device Single Audit Program pilot and plans to release documentation shortly.

In addition to looking abroad, Japanese health authorities have promised to cut device review times, in cooperation with industry. Masanori Otake, regulatory affairs and policy manager of GE Japan, confirmed industry’s commitment to working with the government in a collaborative manner and highlighted steps taken to setting standard review periods. Still, challenges remain.

For example, QMS inspections tend to lengthen the total review period, Otake said. Further, the sheer number of inspections is overwhelming, highlighting that there were 354 in June 2015. “It is too much to have the inspector do that,” he added.

Otake also pleaded with authorities to finally unveil a clinical evaluation guideline, which has been in final stages. He added that industry and regulators will meet before the end of the year to discuss issues, including reviewing QMS inspections to develop a long-term plan and evaluating whether PMDA consultation meetings are being held effectively.

Read the PMDA’s International Strategic Plan here: www.fdanews.com/110215-PMDA-plan.pdf. – Elizabeth Hollis