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Regulatory Tools P rovided in Japan

Regulatory Tools P rovided in Japan. Shingo Sakurai, Ph.D Senior Director for Manufacturing Quality and Compliance PMDA, Japan. New active substance (NAS) median approval time for six regulatory authorities in 2008-2017(Pharmaceuticals). PMDA 333.

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Regulatory Tools P rovided in Japan

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  1. Regulatory ToolsProvidedinJapan Shingo Sakurai, Ph.D Senior Director for Manufacturing Quality and Compliance PMDA, Japan

  2. New active substance (NAS) median approvaltime for six regulatory authorities in 2008-2017(Pharmaceuticals) PMDA 333 Center for Innovation in Regulatory Science (CIRS), 2018, R&D Briefing 67 2

  3. SAKIGAKE Designation System Established the “SAKIGAKE-designation system” to apply innovative drugs/medical devices/regenerative medicines in practical use in Japan sooner than other countries, aiming at early practical application with various supports (granting approval in 6 months, i.e, half the usual time). Designating criteria • Breakthrough treatment/diagnostic method: novel medical device in principle • Firstly developed and planed to submit application for approval in Japan • (concurrent submission allowed) • Expected significant efficacy for a target disease, such as much improvement from existing treatment considering non-clinical data (mechanism of action, etc.) and early phase clinical data. ：Shortening the time to approval Details of designation system ③Priority review 〔12 months 　→　6 months 〕 ○　The goal of total review period is 6 months * Submission of the Phase 3 study results after the application may be permitted to shorten the time from development to granting approval ①Priority consultation 〔2 months　 → 　１ month〕 ○　Communicating with consulter swiftly to shorten the time from submission to a clinical trial consultation ②Enhanced pre-consultation 〔 Substantive accelerated review〕 ○　Enhanced pre-consultation meeting allowing English materials ⑤ Enhanced post-marketing safety measure〔prolongation of reexamination period〕 ○ Improving post-marketing safety measure including expanding reexamination period, transmission of information overseas and collaboration with academic societies ④Review partner 〔PMDAconcierge〕 ○　Offering a concierge who supervises a necessary process including review, safety measure, quality management and quality assurance

  4. New SAKIGAKE Designation (April 2019) • New SAKIGAKE products: • designated in April 2019 (4th term) • 5 Drugs • 4 Medical Devices and IVDs • 2 Regenerative Medical Products • adds up to >40 in total

  5. Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) • Established in April, 2016 • Approved as formal APEC Training Centers of Excellence (CoE) for Regulatory Sciences • Promote capacity building and human resource development through training seminars for • Asian regulators. Action Policy of PMDA-ATC Contribute to universal health coverage in Asia through developing a foundation for regulatory harmonization in the Asian region. Japan Asian countries Invites Asian regulatory representatives and offers training seminars. Visits sites and conducts lectures, case studies and practical trainings. Shares Japanese knowledge and experiences in the regulation of pharmaceuticals and medical devices with Asian countries. Provides trainings tailored to local needs for more people.

  6. Thankyouforyourattention

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