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Handling of the Optimal Clinical Use GuidelinesĬlinical Trials Conducted on Ethical Groundsīasic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trialsīasic Principles on Electronic Submission of Study Data for New Drug Applications Implementation of a Conditional Early Approval System for Pharmaceutical Products Guideline for Clinical Evaluation of Antibacterial Drugs Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs New “Standard Forms for Requesting Clinical Trials, etc.” Partial Revision of New “Standard Forms for requesting clinical trials, etc.” Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis Guideline for Exposure-Response Analysis of Drugs Guideline for preclinical safety assessment of oligonucleotide therapeutics

Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical productsĬonsiderations for the Clinical Evaluation of Drugs in Pediatric Patients (10 or 12 Years of Age and Older) Who Can be Evaluated Together with Adults Guidelines for Analysis Reports Involving Physiologically based Pharmacokinetic Models Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical ProductsĪmendment to “Basic Principles on Global Clinical Trials (Reference Cases)”Įnglish Translations of Guidelines for Bioequivalence Studies of Generic Productsīasic Concept on Bioequivalence Evaluation for Addition of Formulations with Different Dosage Forms in Ethical Kampo Formulationsīasic principles on Utilization of Registry for Applications

The PMDA shall not be responsible for any consequence resulting from use of the English version. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. The following English translations of Japanese notifications and administrative notices are intended to be a reference material to provide convenience for users.