Japan Pharmaceutical Regulations

In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.

Table of Contents

REGISTRATION
Document Title Issued by Description Available Languages Download
PMDA: Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics PMDA For the submission of applications for drugs defined in Section 2.(7) of Part I of Notification No. 0304004 dated March 4, 2009),  referred to as “follow-on biologics”, applicants should generate and collect data for submission in accordance with this Guideline. English For Sale
PMDA: Points to Consider for Reducing Total Review Time for New Drug Applications PMDA The PMDA guidance document outlines points to reduce total review time for new drug applications from the standpoint of shortening the time taken by the applicant. English For Sale
PMDA: On the Standard Review Timeline for New Drug Applications PMDA The Mid-term Plan of the Pharmaceuticals and Medical Devices Agency (PMDA) (authorized under MHLW-PFSB No. 0331002 dated March 31, 2009) sets a target for the total review time for new drugs, aiming at a median time of 12 months for standard review products. English For Sale
PMDA: Basic Principles on Electronic Submission of Study Data for New Drug Applications PMDA This PMDA notification describes only the general principles and that the details regarding electronic submission of study data for new drug application (NDA) will be notified. English For Sale
QUALITY
Document Title Issued by Description Available Languages Download
PMDA: Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices PMDA This Ministerial Ordinance is intended to provide the standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices. English For Sale
PMDA: Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs PMDA Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs in Japan. English For Sale
PMDA: Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics PMDA For the submission of applications for drugs defined in Section 2.(7) of Part I of Notification No. 0304004 dated March 4, 2009),  referred to as “follow-on biologics”, applicants should generate and collect data for submission in accordance with this Guideline. English For Sale
PMDA: Ensuring the Quality and Safety of Gene Therapy Products PMDA The MHLW guideline aims to establish procedures for quality and safety assessment based on regulatory science, to facilitate development of innovative drugs, medical devices, and regenerative medical products. English For Sale
GOOD PRACTICES
Document Title Issued by Description Available Languages Download
PMDA: Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs PMDA Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs in Japan. English For Sale
PMDA: Ministerial Ordinance on Good Clinical Practice for Drugs PMDA This Ministerial Ordinance is intended to provide the standards, which serve as the GCP for Drugs, so as to ensure the scientific quality of clinical trials and the reliability of clinical trial data while the rights, safety and welfare of human subjects are protected and promoted. English For Sale
PMDA: Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs PMDA This MHLW Ordinance provides guidance concerning standard for conduct of nonclinical safety studies of drugs [limited to the generation and collection of data on acute, sub-acute and chronic toxicity, genotoxicity, teratogenicity, and the other toxicity studies conducted at test facilities or test sites using test systems. English For Sale
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