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Commentary: Japan's regulator has a plan, but needs to live up to it

This article was originally published in Scrip

Executive Summary

Scrip's Asia editor Ian Haydock casts a critical eye over a new international plan from Japan's regulator, the PMDA.

Scrip's Tokyo-based Asia editor Ian Haydock

Last month, Japan's drugs and medical devices regulator, the PMDA, released through its website an English translation of a bold new "international strategic plan" which laid out a number of broad policy objectives.

These were related not so much to the approval of products but more to the course of the agency's external relationships over the next five years. The general message was: More co-operation! More exchange of people and information! More harmonisation! More transparency!

It might be easy to dismiss the document as an academic exercise designed to appease the agency's critics. But talk to senior company executives who deal with the PMDA and its reviewers and the overriding picture you get these days is a positive one. Early consultation and flexibility are the order of business.

Understaffing and the slowness of approval reviews have been a major bugbear for sponsors over the past few years, leading to Japan's oft-criticised "drug lag" problem, whereby many new products remain unapproved in the country.

The agency itself, set up just over five years ago, is surprisingly candid about its culpability, freely admitting that it has a lot of work to do. And it has been taking action for several years, ranging from support for new clinical networks, through to the setting up of a committee on unapproved drugs, to a steady increase in review staff. But the impact of these moves will take some time to flow through.

A new mid-term action plan released earlier this year envisaged the number of reviewers rising by 200 by April next year, and median review times falling to 12 months in the year beginning April 2011 (scripnews.com, February 16th, 2009).

Its own performance reviews suggest things are improving, albeit slowly, helped by more priority reviews and faster conditional approvals linked to comprehensive post-marketing safety programmes.

It should be said here that it would be wrong to lay the blame for the drug lag entirely at the PMDA's door. Companies themselves may decide in their own evaluations that the market opportunity in Japan is not big enough, or medical practices are just too different, to justify the local development of a particular project. Resources may also need to be concentrated initially on the biggest markets, such as the US.

In fact, one executive conceded to me recently that the drug lag could even work in an applicant's favour. This is because it gave more time for a convincing body of clinical data to be generated elsewhere, which could be used in support of a later submission in Japan. Regardless, the trend now is towards the early inclusion of Japan in global development programmes to allow more or less simultaneous submissions.

The PMDA's new international action plan sees the agency playing a much more proactive role on the global stage, through increased interaction with its counterparts in the US and EU, and stronger ties with its North Asian neighbours South Korea and China. This will be achieved in part through the seconding of PMDA officers and acceptance of trainees.

Although it does not go into specifics, the plan outlines initiatives for the international sharing and dissemination of regulatory information, and improved co-operation in areas such as GCP and GMP inspections.

It also sees the PMDA playing an active role in regulatory harmonisation initiatives, including those overseen by the World Health Organization.

Significantly, one of its main goals is the "fostering of internationally minded human resources with communication skills". What this rather grandiose objective will entail in practice is the provision of more information – such as product reviews, official notices and other documents – in English. There will also be increased language training within the agency (hopefully overcoming one of Japan's main handicaps on the global stage), and more of an effort to reach out to foreign media.

Maybe, at the same time, the agency needs to step outside its Japanese cultural constraints and proactively shout out more about what it is doing and has achieved.

To a large extent, the international plan merely formalises a number of programmes the agency is already pursuing. For example, regular talks with China and South Korea over clinical data requirements and ethnic differences are already under way, as are exchanges with the US FDA and EMEA. But it can't hurt to get down on paper (or the internet at least) a series of objectives to measure progress by.

Despite the ongoing problems, applicants have good reason to be optimistic about the regulatory environment in Japan, which has improved markedly. The PMDA's recognition of its shortcomings and the steps it is taking to address these are a marked departure from the past. Although it is only right to expect a national regulatory agency to deliver safe and effective new medicines to its citizens without delay, such progress deserves to be recognised by the industry.

To some extent, regulatory issues do indeed appear to have slid down the priority list of foreign associations in Japan, which now seem more concerned about reimbursement pricing and vaccine issues.

The same goes for the Japanese industry, which has always been less vocal in its public criticism of the PMDA in line with cultural norms.

The PMDA has set itself some challenging goals in its new plans. All it has to do now is live up to its promises, and it can call itself a truly world class regulatory agency.

Ian Haydock is Scrip's Tokyo-based Asia editor.

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