MHLW To Expand Drug Application Consultation Services July 1, But With A Price Tag For Industry
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Japan's Ministry of Health, Labor and Welfare established a panel to improve the Pharmaceuticals and Medical Devices Agency's consultation services as one measure to eliminate Japan's drug and medical device lag, and the agency is expected to expand the range and number of consultations starting this year
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TOKYO - Japan's Ministry of Health, Labor and Welfare established a panel to improve the Pharmaceuticals and Medical Devices Agency's consultation services as one measure to eliminate Japan's drug and medical device lag, and the agency is expected to expand the range and number of consultations starting this year. Currently, PMDA conducts consultation services for drug manufacturers when their drug candidates reach clinical development. But industry and academia are urging PMDA to offer preclinical consultations to encourage development of new medical technologies and to foster the growth of biotech venture companies and academia. The public and private sectors argue that the lack of support for translational research for biotech ventures and academia inhibits Japanese biotechnology venture companies and contributes to the drug lag. But last year, MHLW cited low usage by companies as the reason the ministry closed its clinical study services for venture companies. MHLW consolidated all consultation services under PMDA, which has tried to improve transparency and industry participation, partly for global clinical trials (Also see "Japan's Improved Clinical Trial Requirements Bring Positive Impact To China, Korea Development" - Pink Sheet, 4 Jan, 2011.). The idea to enhance PMDA's consultation services was proposed at a 2010 meeting to address the regulatory needs for new regenerative medicine technologies. PMDA will launch new consultation services in July, and now that consultations will be expanded, the regulatory strategy panel is trying to determine which medical technology fields should be given priority and how to conduct consultations efficiently. The panel, named "The Conference on Pharmaceuticals and Medical Devices Regulatory Strategy," held a hearing May 20 for medical experts and representatives from pharmaceutical and biotech venture companies to offer public comment. Fees Proposed For Regulatory Consultations During the meeting, PMDA proposed fees for the regulatory consultation services that start July 1. PMDA will charge ¥1.49 million per consultation for pharmaceutical companies and ¥0.14 million for biotech venture companies and academia with certain conditions. PMDA is now inviting public comment on the fees. Jin Shiomura, executive of the SAMURAI Biotech Association, an association of small biotech venture companies in Japan, and president of Nobel Pharma, said PMDA's consultation process currently falters by not taking new technologies into consideration. He added that the agency is often inconsistent in its decisions between consultation and review, and the agency's officers demonstrate a "self-protective attitude." But Shiomura was also optimistic that these problems will be resolved by PMDA's efforts to revise the consultation process. Osamu Inagaki, chairman of the Japan Pharmaceutical Manufacturers Association's drug evaluation committee, stressed the need for establishing a regulatory environment conducive for early clinical development to create opportunities for innovative drugs in Japan. He urged MHLW to respond flexibly to clinical trial designs in accordance with new technology. Inagaki also asked MHLW to reexamine the existing regulatory requirements to improve accompanying materials for clinical trial notification, for example by making an English version in order to promote global drug development, and by changing the definition of causal relationships of adverse reactions to evaluate safety in terms of a global perspective. - Ro Midorikawa ([email protected]) |