Regulations
A descriptive paragraph that tells clients how good you are and proves that you are the best choice that they’ve made.
Useful list of PMDA and MHLW guidance documents
These include the following:
Japanese Regulatory Agency and Ministry of Health
Pharmaceutical and Medical Device Agency (PMDA)
https://www.pmda.go.jp/english/index.html
Ministry of Health Labour and Welfare (MHLW)
https://www.mhlw.go.jp/stf/english/index.html
Orphan Drug Designation in Japan
Overview of Orphan Drug and Medical Device Designation in Japan
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html
New changes by MHLW to Orphan Drug designation system (Jan 2024)
https://www.mhlw.go.jp/web/t_docdataId=00tc8207&dataType=1&pageNo=1
PMDA considerations for J-NDA
Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drugs
https://www.pmda.go.jp/files/000153830.pdf
Japanese Pharmacopoeia
Detailed information and documents about Japanese Pharmacopoeia
https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0009.html
Medical Devices
Approval and Certification of Medical Devices
https://www.pmda.go.jp/english/review-services/reviews/0004.html
Japanese Guidelines by PMDA and MHW for Clinical Development
Basic Principles on Global Clinical Trials 2007
http://www.pmda.go.jp/operations/notice/2007/file/0928010-e.pdf
Basic Principles on Global Clinical Trials (references cases)
http://www.pmda.go.jp/kijunsakusei/file/guideline/new_drug/GCT-jirei_en.pdf
Basic Principles about Implementation of Phase I Study for Japanese before Participating into Global Clinical Trial. Released on 27th Oct 2014
https://www.pmda.go.jp/files/000157777.pdf
Basic Principle on Global Clinical trials and waver of Ph.1 studies in Japanese (NEW 25 Dec 2023)
https://www.mhlw.go.jp/hourei/doc/tsuchi/T231226I0030.pdf
Q&A for basic principles for conducting/not conducting phase 1 studies (NEW 25 Dec 2023)
https://www.mhlw.go.jp/hourei/doc/tsuchi/T231226I0030.pdf
Registration of foreign Manufacturing sites
Japanese guidelines on Foreign Manufacturer Accreditation (FMA)
https://www.pmda.go.jp/files/000153619.pdf
Master File System in Japan
Detailed information on Drug Master File including Q&A is in the link below
https://www.pmda.go.jp/english/reviewservices/reviews/mf/0001.html
Regulatory Strategy
- Independent assessment report on development and registration pathways in Japan.
- Integration of Japan into global regulatory strategy.
- Regulatory requirements during development and for registration (CMC, Non-clinical and Clinical).
- Japan-specific Precedence analysis & Regulatory Intelligence.
Conditional Approval
- Exploring eligibility for conditional approval, Strategy, Preparation of Docs and F2F meetings with PMDA. Etc.
PMDA Scientific Advice
- Support includes all aspects starting from Strategy, preparation of Docs, F2F meetings and daily interactions with PMDA.
Orphan Drug Designation
- Support includes all areas related to orphan designation (Strategy, Preparation of Docs and F2F meetings with MHLW).
Japan NDA
- Gap Analysis, Preparation and review of CTD (CMC, non-clinical and clinical), submission of NDA and support during interactions with PMDA.