Japan Pharmaceutical Regulations
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 |
|---|---|---|---|---|
| Ministerial Ordinance 136: 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 |
| Ministerial Ordinance 179 : Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (GMP Requirements) | 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 |
|---|---|---|---|---|
| Ministerial Ordinance 161: Good Clinical Practice (GCP) for Drugs in Japan | 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 |
Drug Master File (DMF)
| Document Title | Issued by | Description | Available Languages | Download |
|---|---|---|---|---|
| Master File System for Drug Substances (DMF) in Japan | PMDA | Master file system for drug substances allows Japanese or foreign manufacturers of drug substances etc. to voluntarily register the data concerning the quality/manufacturing methods of their drug substances, used for manufacture of drugs (pharmaceutical products) to the review authority. | English | For Sale |