Dec 17, 2014

In conjunction with the recent implementation of the Pharmaceutical and Medical Device Act (PMD Act), Japanese regulators have launched a new pre-consultation program to assist registrants as they begin their device certification application processes.

The Taimenjogen program, launched in late November 2014 concurrent with the PMD Act’s implementation, includes six different pre-certification PMDA consultation options at various price points, and is intended to further clarify Japanese registration requirements for manufacturers.

The PMDA’s pre-consultation options include:

  • General Introduction Consultation (Zenpan Sodan): introduces relevant MHLW guidance notifications and regulations to applicant and suggests which further pre-consultation pathways for applicant to take
  • Pre-Meeting for Pre-Consultation (Taimen Jogen Junbi Mendan): PMDA confirms and organizes materials and issues to be discussed during formal Pre-Consultation
  • Pre-Development Consultation (Kaihatsumae Sodan): Consulting on applicant’s expected data package framework, including any required device testing and clinical investigation
  • Clinical Trial Necessity Consultation (Rinsho Yohi Sodan): Determining whether additional clinical trials based on existing clinical or non-clinical data will be necessary
  • Protocol Consultation (Protocol Sodan): Consultations on specifications for safety, quality, performance testing, pilot studies and clinical trial protocol validity
  • Simple Consultation (Kani Sodan): Consultation to determine applicant’s appropriate submission route, and whether applicant can register an entire product family through a single registration application

Although not as straightforward as the US Food and Drug Administration’s Pre-Submission consultation system for registrants, the PMDA’s pre-consultation program nonetheless allows manufacturers unfamiliar with Japanese pre-market certification and approval requirements to get a better idea of the steps necessary for obtaining market authorization.

 

Author

  • Stewart Eisenhart

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