CMC


Japan’s PMDA is offering meetings


 

To help manufacturers to rule out confusing regulatory approvals, Pharmaceuticals and Medical Device Agency (PMDA) offers meeting to answer manufacturer´s consultations. The reason of this benefit is because the PMDA want all multinational manufacturers, who want to distribute in Japan, know and understand all the regulations before submitting approval application.

These are the more important types of consultations for medical devices:

-       Consultation before and during R&D phases

-       Consultation about the need of clinical study

-       Consultation about the requirements and evaluation of: (i) Safety, (ii) Quality, (iii) Performance, (iv) Exploratory Clinical Trial, and (v) Clinical Trial

-       Consultation about the documents submitted and submission category

-       Consultation about clinical trial expansion

These are the more important types of consultations for IVD:

-       Consultation about different types of meetings

-       Consultation about IVDs pre-developments

-       Consultation about companion diagnostics pre-developments

-       Consultation about requirements and evaluation of: (i) Quality, (ii) Performance (other than Quality), (iii) Correlativity, (iv) Clinical Performance Tests, and (v) Clinical Performance Tests for CoDx

-       Consultation about the submission process

After these meetings, if any manufacturer need further recommendation could be held a new consultation.


Sources: NAMSA < https://www.namsa.com/asian-market/japans-pmda-consultation-offering/​ >