Drug Safety Management in Japan: An Update on Current and Future Regulations

Japan's pharmaceutical market is the second largest in the world but has long suffered from the so-called drug lag.

Lengthy approval processes for drugs have seen medicines readily available in the rest of the world take months, if not years, longer to hit the Japanese market and this has no doubt hampered its development.

Slashing the length of time it takes to get these lifesaving drugs in the hands of patients, while ensuring safety standards, has been a renewed priority for the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in recent years.

In its second mid-term plan, covering the period of 2009 to 2013, it acknowledged that if it hopes to deliver "more effective and safer pharmaceuticals and medical devices more quickly" it must take steps to better harmonise its regulatory efforts with those of the medical community.

Steps taken to cut the approval time have already had an effect. Figures reported by pharmaregulatoryaffairs.com show the average duration for regular product reviews was 22 months in 2008 and this fell to 19.2 months in 2009.

The biggest change in approach, however, has come in the steps to allow clinical data not obtained in Japan to be used in the approval process.

Speaking to the website, Dr. Hideo Utsumi said supportive funding is likely to be made available to allow the trials to assure the safety of drugs where supportive information is not considered to be sufficient. However, the PMDA said this is likely to only be a short-term measure until the drug lag issue is rectified.

Meeting the new standards surrounding the use of clinical data obtained outside Japan has already presented opportunities for clinical research organisations.

Paraxel opened a new office in Nagoya, Japan, late last year to meet growing demand. Josef von Rickenbach, chairman and chief executive officer, of the company, said: "Our regulatory and clinical experts are supporting what we call 'Japan plus Asia' studies since recent regulatory changes allow for inclusion of non-Japanese data for registration purposes.

"We are also supporting Japan-based biopharmaceutical companies with simultaneous global clinical studies across a broad range of therapeutic areas, and providing eClinical solutions to accelerate the clinical development process."

Companies operating within the medical device sector have seen similar opportunities for meeting Japan's stringent requirements. Regulatory affairs consultants Emergo Group and clinical research organisation Data Pharma also signed a deal to offer full clinical trial services in Japan.

Michiharu Miyahara, chief executive officer of Emergo Japan KK, said there is a growing need for consultancies offering such services to enter the Japanese market.

"The Japanese government has a strategy to drive growth in the life sciences industry, but this has been challenging due to the complexity of conducting clinical trials in Japan which are sometimes needed to obtain regulatory approval," he added.

For the PMDA, the future of its roles lies in greater collaboration with international regulatory agencies like the United States Food and Drug Administrations and the European Medicines Agency.

The agency is looking to create an environment in which greater exchange of good practice information is facilitated, suggesting in the future more data from overseas clinical trials could be used within the approval process.

Efforts are also being made to improve the provision of English information on its website. A draft of the PMDA's risk management guidance was recently published in English.
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While the Japanese regulatory system is still not as efficient as that in other markets, the size of the opportunity for pharmaceutical companies means it cannot be ignored. When devising a global strategy, companies should take into account the requirements of Japan, and the Japan plus Asia studies being developed by Paraxel show there is some recognition of this.

Regulatory changes which speed up the approval process are only likely to make the market more competitive in the future and preparations should be made for this now.