![]() ![]() under the Revised Pharmaceutical Affairs Law ![]() Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. Handling of Applications for GMP Inspections Guidance on the Implementation of the Ministerial Ordinance on the Good Laboratory Practice for Nonclinical Safety Studies of Drugs as Revised by the Ministerial Ordinance for the Partial Revision of the Ministerial Ordinance on the Good Laboratory Practice for Nonclinical Safety Studies of Drugsīasic Principles on Global Clinical TrialsĬancellation of items registered in Drug Master Filesĭocuments to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs Guideline for the Quality, Safety and Efficacy Assurance of Follow-on Biologics Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs Points to Consider for Reducing Total Review Time for New Drug Applications On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents On the Standard Review Timeline for New Drug Applicationsįormat for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time Question and Answer Guide Regarding "Basic Principles on Electronic Submission of Study Data for New Drug Applications"īasic Principles of Risk-based Monitoringīasic Principles on Global Clinical Trials (Reference Cases)Įnglish Translations of the Guidance for Establishing Safety in First-in-Human Studies during Drug Development and its Questions and Answers 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. ![]()
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