Japan’s Pharmaceutical Affairs Law (PAL)
Japan Regulatory Environment
Recent years have seen an expansion of medical research and development activities in Japan, the United States, the European Union, Asia and other regions, as well as population aging and advanced technological innovation in fields such as biotechnology and new medical devices.
Terms such as drug lag and device lag in the medical field refer to the long time it takes to obtain approval for new medical developments in Japan in comparison with other countries. Many devices that have been approved and are widely used in other countries have not yet been approved in Japan, and in some cases, only devices from two or three device-generations ago are available.
However, in recent years, the environment surrounding the public administration of pharmaceutical affairs in Japan has changed radically. To combat the situation of delayed approval for medical developments, MHLW (Ministry of Health, Labour and Welfare) implemented a major revision of the Pharmaceutical Affairs Law (PAL) in 2002 and reformed the related approval and licensing system.
In 2003, a system for investigator-initiated trials was started, and the existing system for ensuring the safety of drugs and medical devices was enhanced by the introduction of biological product regulations.
In 2004, the introduction of marketing Business licenseswith the product license-holder function separated from the former manufacturing business license allowed companies to market drugs and medical devices without having to manufacture them directly. A requirement for QMS compliance (including overseas auditing) for marketing approval was also introduced, and new regulations on medical devices according to their classification were provided, including a new system for accreditation by registered notified bodies.
In April 2004, the Pharmaceuticals and Medical Devices Agency (PMDA) was established as an Incorporated Administrative Agency (IAA), and started to provide services related to functions for approval review of drugs and medical devices, consulting services such as clinical studies and GCP auditing with the aim of ensuring the safety and efficacy of drugs and medical devices in Japan.
Despite a period of transition and some initial confusion with the system, the change has improved the efficiency of the review system by delegating the review and certification processes to external organizations (i.e., registered certification bodies) for many widely used Class II devices such as endoscopes and ultrasound diagnostic systems. This delegation conforms to certification guidelines based on international standards. MHLW is also in the process of establishing a set of approval criteria based on international standards in regard to medical devices for which clinical trial data are not required.
For an overseas company wishing to enter the Japanese market, it is essential to develop a regulatory strategy based on a solid understanding of its duties as a foreign manufacturer as well as the options available and the pros and cons of each.
In November, 2014, the Ministry of Health, Labour and Welfare revised the Pharmaceutical Affairs Law to ensure safe and prompt provision of pharmaceuticals, medical devices, etc. The amendments include establishment of obligation to notify the package insert, expansion of the range of medical device certification performed by registered certification bodies, and establishment of requirements for cellular and tissue-based products. With this revision, the name of the law was changed from “Pharmaceutical Affairs Law” to “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.” In this report, however, hereinafter referred to as “the PAL” for the sake of convenience.
The Japanese government’s announcement of several decisions on Pharmaceutical Affairs Law (PAL) revision
Japan has one of the fastest and most pronounced rates of aging in the world – a demographic trend that results in higher incidence rates of cancer, cardiovascular disorders and lifestyle-related diseases such as diabetes and hyperpiesia. Despite this background, in reality, new medical products in Japan are approved around 10 years later than in other countries. The complexity and difficulty of the Japanese regulatory environment is one of the major factors contributing to the issues of drug lag and device lag.
To address these issues, the Pharmaceutical Affairs Law (PAL) was dramatically revised in 2005. Although this improved the situation, the government decided to implement further revisions to address the current problems of drug lag/device lag. Manufacturers/applicants need to know about these changes and local regulations in order to obtain regulatory approval in a timely manner.
In November, 2014, the Ministry of Health, Labour and Welfare revised the Pharmaceutical Affairs Law and enforced the “Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics” in order to ensure safe and prompt provision of pharmaceuticals, medical devices, etc.
In this report, however, hereinafter referred to as “PAL” for the sake of convenience.
The major amendments are as follows:
(1) Requirements for marketing and manufacture of medical devices are stipulated in a separate chapter from pharmaceuticals and other products.
(2) The certification system for medical devices performed by private, independent bodies is extended to specially controlled medical devices with specified standards.
(3) Stand-alone programs used for diagnosis and the like are subject to marketing approval or certification as medical devices.
(4) The license system for manufacture of medical devices is simplified to a registration system.
(5) Rationalization is promoted in the compliance inspections of manufacturing and quality control methods of medical devices.
(6) A new definition of “cellular and tissue-based product” is established, and regulations for their safety measures are stipulated taking their characteristics into account.
As your trusted partner
Japan MDC is an marketing and regulatory consulting firm for medical device manufacturers.
We play a cooperative role in work on such revisions with the government and related industrial groups. As a result, it is in a strong position to help applicants navigate the related registration process for medical devices and offer a variety of support services for product registration with its expert knowledge of trends in Japan’s regulatory environment.Our experienced marketing specialists and regulatory specialists collaborate closely to help you achieve your goals. We are not a big company, but we do quality work. Much like a trusted partner, we are flexible, reliable and a dependable ally for you.
Japan MDC provides following total services for medical devices.
・Clinical trial management
・Consulting and support for GCP inspection
・Business license related services
・Feasibility regulatory research for regulatory due diligence
・Research and development support
・Marketing consulting for new products
・Marketing support as your MAH or DMAH
If you need any further information regarding our services, please do not hesitate in contact us.
Please refer to our publication for more detailed information.