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Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is an organization that was born in 2004 out of three entities: the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC); the Organization of Pharmaceutical Safety and Research (OPSR); and the Japan Association for the Advancement of Medical Equipment (JAAME). Working closely with the Ministry of Health, Labour and Welfare (MHLW), the PMDA aims to create a regulatory process to deliver safer, more effective medicines and medical devices. PMDA Chief Executive Officer Dr. Tatsuya Kondo shared a look at the agency’s goals, recent challenges, and the future of the industry on October 18 at Tokyo American Club.

Providing new product reviews, putting in place post-marketing security measures, and getting relief to people who have suffered from adverse drug reactions are three key functions that the PMDA carries out. These are closely connected and form the PMDA Safety Triangle—a compre­­hensive risk-management frame­work that is supported by three core operations: review, relief, and safety. The PMDA is the only regulatory authority in the world to operate on this integrated, three-tier basis.

Kondo said the PMDA has three pillars:

  • Philosophy
  • Regulatory Science
  • International Cooperation

Supported by these pillars, the PMDA hopes to continue providing its Rational Medicine Initiative, a patient-centric system that brings a holistic approach to medicine. Based on the latest scientific knowledge, the initiative applies from the perinatal to final stages of life, Kondo explained.

As a way to streamline the current system, the PMDA is promoting regulatory inno­va­tion based on regulatory science. “Regula­tory innovation is important from the stage of development reviews to post marketing,” Kondo said.

The PMDA has implemented many innova­­tive regulatory initiatives, including the SAKIGAKE designation system, a condi­tional early approval system for pharma­­ceuticals, and the MID-NET—or Medical Information Database Network—project.

Most recently, the PMDA established the Regulatory Science Center, which is the hub for the agency’s regulatory science. “We accumulate a lot of experiences and various initiatives based on regulatory sciences,” Kondo explained. “The PMDA has centralized those experiences and established a Regulatory Science Center to promote more-efficient and stronger approaches to arising scientific issues and safety measures.”

A science board was also established in 2012, and the third-term subcommittees discussed rare cancers, drug development, and artificial intelligence (AI). The Drug Development Subcommittee aims to decide on information for drug equipment. The AI Subcommittee discusses the current state, limitations, and applications of AI technology with the aim of summarizing the expected risks associated with medical devices that rely on AI. These discussions are written up and made available to the public on the PMDA website.

Three years ago, the PMDA established the PMDA International Strategic Plan 2015, which comprises three visions:

  • Contributing to the world through regulatory innovation
  • Maximizing the common health benefits to other countries and regions
  • Sharing wisdom with other countries and regions

Moving forward, the agency aims to strengthen the translation, as well as the distribution and analysis of information as a way to best help society.

When it comes to international contri­bu­tion, the PMDA has high expectations and is pushing to get involved in a large number of countries. An example is the PMDA Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, set up in 2016. Providing training opportunities and on-site training, the PMDA hopes to share its regulatory knowledge and contribute to increasing regulatory level and capacity worldwide. According to Kondo, 235 regulators from 27 countries and regions participated in 2017—a 50-percent increase from the year before. If this growth continues, the general regulation of medical drugs and devices will improve globally and more patients can receive regulated healthcare.

The luncheon was hosted by the American Chamber of Commerce in Japan Healthcare Committee and its four subcommittees: Digital Health; Medical Devices and Diagnostics; and Pharmaceuticals, Regenerative Medicine and Bioscience.

Megan Casson is a staff writer at Custom Media for The ACCJ Journal.
The PMDA hopes to continue providing . . . a patient-centric system that brings a holistic approach to medicine.