Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Cobridge Co., Ltd.
Tokyo, Japan
We assist medical device companies with the medical device registration and approval in Japan. Regulatory consulting services and DMAH services for foreign manufacturers to enter Japanese market.
MDREX, Medical Device, Digital Health Consulting Group
Seoul, Republic of Korea (HQ), Japan Office
We offer total solutions for market entry in South Korea and global expansion (e.g., Japan, USA, Europe). Key areas include product approval, reimbursement listings (HIRA), and Quality System certification (KGMP). They are particularly strong in innovative products like SaMD, medical wearables, and 3D printing for medical use, and provide in-depth expertise in cybersecurity and clinical trial planning.
CMIC Holdings Co., Ltd.
Tokyo, Japan (HQ), Osaka, Japan, Beijing, China, Seoul, South Korea, Taipei, Taiwan, Singapore, New York, USA, London, UK, Frankfurt, Germany, Sydney, Australia
We operate globally, specializing in accelerating the development, manufacturing, and commercialization of drugs and medical devices. Their expertise spans Phase I to IV clinical trials, regulatory affairs, quality assurance, and manufacturing, with a strong focus on the Japanese and Asian markets. Key services include clinical operations (CRO), manufacturing (CDMO/CMO), site management (SMO), and comprehensive health analysis and solutions.
January 4, 2026
Approximately 5 minutes
Guideline for Clinical Evaluation of Antibacterial Drugs in Japan
Guideline for Clinical Evaluation of Antibacterial Drugs in Japan
1. Background and Purpose
The Guideline for Clinical Evaluation of Antibacterial Drugs was published via the PSEHB/PED Notification No. 1023-3 on October 23, 2017 and replaces the former 1998 version. It was developed to reflect contemporary scientific knowledge, the shift to global simultaneous drug development, and the need to converge data requirements among Japan, Europe, and the United States for antibacterial drug approval.
This guideline provides basic concepts for planning nonclinical and clinical studies necessary to support marketing approval applications for systemic antibacterial drugs. It emphasizes flexibility for applicants to propose alternative methods if properly rationalized based on scientific advancement.
2. Scope and Positioning
The guideline covers the clinical evaluation principles for investigational antibacterial drugs targeting ordinary bacterial pathogens, excluding mycobacteria, fungi, and viruses. It integrates microbiological evaluation with efficacy and safety assessments based on signs and symptoms of infectious diseases.
Clinical evaluation includes phase I–III studies; special population studies (e.g., hepatic/renal impairment, pediatric); methods for trial conduct; and considerations for utilizing foreign clinical data.
3. Nonclinical to Clinical Transition
The guideline highlights that bacteriological studies and pharmacological evaluations (such as in vitro activity, mode of action, resistance mechanisms, and in vivo infected animal models) should inform clinical trial design, helping determine target bacterial species, disease indications, and initial dosing. These nonclinical assessments provide critical context for subsequent clinical studies.
4. Clinical Trial Design Principles
4.1 Phase I Studies
Phase I studies aim to assess safety margins, pharmacokinetics (PK), and tolerability in humans. These may include single and repeated dosing to characterize blood drug concentrations relative to adverse events and microbiological targets, and to estimate dosing for later stages.
4.2 Phase II and Phase III Studies
Phase II studies estimate appropriate clinical doses based on PK/PD analyses and earlier results. Phase III studies are designed to demonstrate efficacy and safety in patients with specific infectious diseases, typically using randomized, double-blind, controlled trials to compare investigational drugs with appropriate controls (such as standard antibacterial therapy). Endpoints focus on clinical cure and microbiological eradication at the time of test-of-cure.
4.3 Special Populations
The guideline addresses clinical evaluation in special populations such as pregnant women, nursing women, pediatric patients, elderly patients, and those with hepatic or renal disorders, with tailored recommendations for inclusion/exclusion criteria, safety monitoring, and analysis plans.
5. Use of Foreign Clinical Data
Utilization of foreign clinical data is permitted if justified. When foreign trial results are used, intrinsic and extrinsic ethnic factors should be assessed to ensure relevance to the Japanese population. Strategies may involve demonstrating similar pharmacokinetics between Japanese and non-Japanese subjects, or including Japanese patients in global trials for key efficacy and safety confirmation.
6. Appendices and Disease-specific Guidance
The guideline includes appendices with disease-specific clinical evaluation considerations (e.g., sepsis, respiratory infections, urinary tract infections, skin/soft tissue infections, pediatric infections) which provide detailed guidance on clinical data packages for each infection type.
7. Flexible and Rational Design
The guideline emphasizes that developers are free to propose alternative study methods or designs so long as they are scientifically sound and justified based on current knowledge, enabling flexibility in the evolving landscape of antibacterial drug development.
Conclusion
The Guideline for Clinical Evaluation of Antibacterial Drugs outlines comprehensive and flexible principles for planning and conducting clinical studies of antibacterial drugs in Japan, aiming to ensure robust evidence for efficacy and safety while aligning with global development practices and regulatory expectations.
Have a Question?
Ask our experts about this topic. We'll do our best to respond to your question.
Related Articles
Approximately 5 minutes
Points to Consider in Developing Drugs for Pediatric Inflammatory Bowel Disease in Japan
PMDA released points to consider for planning clinical studies in pediatric inflammatory bowel disease (IBD) drug development, aiming to improve availability of therapies for children by addressing pediatric-specific challenges.
Approximately 5 minutes
Points to Consider in the Clinical Development of Drugs for Transthyretin Amyloid Cardiomyopathy (Early Consideration) in Japan
This PMDA Early Consideration document outlines strategic clinical development points for transthyretin amyloid cardiomyopathy (ATTR-CM) drugs in Japan, including rare disease considerations, endpoint selection, trial design, and multi-regional development.
Approximately 5 minutes
Points to Consider for the Design of Clinical Trials to Assess the Effects of Psychotropic Drugs on Driving Performance in Japan
This PMDA Early Consideration outlines key considerations for designing clinical trials to assess impacts of psychotropic drugs on driving performance, focusing on clinically meaningful driving impairment and appropriate evaluation methods.
Approximately 5 minutes
Japan Specialty Fulfillment for Medical Devices: Low Volume, High Value Sales
Specialty Fulfillment is a crucial service for foreign medical device manufacturers targeting low-volume, high-value sales in Japan, often utilizing an Independent License Holder to manage customs, storage, and distribution to maintain high profit margins.
Approximately 5 minutes
Points to Consider for the Design of Clinical Trials to Assess the Effects of Psychotropic Drugs on Driving Performance in Japan
This PMDA Early Consideration outlines key considerations for designing clinical trials to assess impacts of psychotropic drugs on driving performance, focusing on clinically meaningful driving impairment and appropriate evaluation methods.
Approximately 5 minutes
Guideline for Clinical Evaluation of Antibacterial Drugs in Japan
The PMDA’s *Guideline for Clinical Evaluation of Antibacterial Drugs* provides comprehensive principles for designing and conducting clinical studies of antibacterial drugs for regulatory approval, reflecting current scientific knowledge and global harmonization.
Approximately 5 minutes
Considerations for Non-clinical Studies of Combination Prescription Drugs with Similar Formulations in Japan
PMDA’s Early Consideration document clarifies how non-clinical pharmacology and toxicology studies should be approached for combination prescription drugs whose formulations are similar to approved products.
Approximately 5 minutes
Points to Consider for Clinical Development of Drugs Intended for Treatment of Psoriatic Arthritis in Japan
This PMDA Early Consideration outlines current regulatory thinking for clinical development of psoriatic arthritis (PsA) drugs in Japan, including disease characterization, endpoints, study design considerations, and use of global data.
Approximately 5 minutes
On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents in Japan
The *Guideline for Clinical Evaluation of Oral Hypoglycemic Agents* provides comprehensive procedures for planning, conducting, and evaluating clinical studies of oral hypoglycemic agents in Japan, focusing on glycemic control markers, safety evaluation, and inclusion of relevant patient populations.
Approximately 5 minutes
Considerations for Non-Clinical Studies in the Development of Diagnostic Radiopharmaceuticals in Japan
PMDA’s Early Consideration (Mar 26, 2025) explains when non-clinical packages for diagnostic radiopharmaceuticals can be streamlined (e.g., microdose), and how to address safety pharmacology, DDI/ADME, toxicity, and radiolytic impurities.
Approximately 5 minutes
Guideline for Clinical Evaluation of Diagnostic Radiopharmaceuticals in Japan
PMDA/MHLW’s guideline (PFSB/ELD Notification No. 0611-1) explains how to design non-clinical and clinical evidence for diagnostic radiopharmaceutical approval in Japan, emphasizing imaging accuracy, clinical significance, and radiation dosimetry.
Approximately 5 minutes
Checklist for Japan’s 30-day Clinical Trial Notification Review (Initial CTN, Oncology Drugs)
PMDA’s early-consideration checklist summarizes what reviewers expect to see in an initial CTN for oncology drugs—covering safety reporting workflows, Phase 1 population ethics, starting dose rationale, DLT/tolerability evaluation, informed consent essentials, and required attached documents.
Approximately 5 minutes
Statistical Considerations for Phase I Oncology Trials in Japan (Safety-focused Early Consideration)
PMDA’s early-consideration paper explains what statistical evidence and simulation outputs should support oncology Phase I dose-escalation designs in Japan’s 30-day CTN review, with emphasis on safety, termination behavior under excessive toxicity, and managing design modifications like backfilling or schedule changes.