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)

Ministry of Health Labour and Welfare (MHLW)

Orphan Drug Designation in Japan
PMDA considerations for J-NDA

Points to Be Considered by the Review Staff Involved in the Evaluation Process of New Drugs

Japanese Pharmacopoeia

Detailed information and documents about Japanese Pharmacopoeia

Medical Devices

Approval and Certification of Medical Devices

Japanese Guidelines by PMDA and MHW for Clinical Development

Basic Principles on Global Clinical Trials 2007

Basic Principles on Global Clinical Trials (references cases)

Basic Principles about Implementation of Phase I Study for Japanese before Participating into Global Clinical Trial. Released on 27th Oct 2014

Basic Principle on Global Clinical trials and waver of Ph.1 studies in Japanese (NEW 25 Dec 2023)

Q&A for basic principles for conducting/not conducting phase 1 studies (NEW 25 Dec 2023)

Registration of foreign Manufacturing sites

Japanese guidelines on Foreign Manufacturer Accreditation (FMA)

Master File System in Japan

Detailed information on Drug Master File including Q&A is in the link below

Regulatory Strategy
Conditional Approval
PMDA Scientific Advice
Orphan Drug Designation
Japan NDA