Regulatory
규제기관 문서
FDA, EMA, PMDA, 식약처 문서를 국가·기관·주제·연도 기준으로 표 형태로 정리합니다.
표 전체 보기Watch
자동 수집된 최신 문서와 논문을 정리하는 섹션
여기서는 무엇이 새로 나왔는지, 무엇을 먼저 봐야 하는지, 지금 어떤 키워드가 반복되는지를 정리합니다.
Focus now
우선 볼 문서
BMJ (Clinical research ed.) · 2026-02-17
Guiding causal inference research in general medical journals.
핵심 방법론 키워드가 포함되어 있어 글감으로 확장하기 좋습니다.
MFDS
[Australia] FSANZ has updated the Compendium of Microbiological Criteria for Food (2025-08-04)
가이드라인 또는 권고문 성격이 강해 설계 기준에 직접 영향을 줄 수 있습니다.
MFDS
[UK] FSA launches consultation on proposed ban of Bisphenol A (BPA) and related chemicals in food packaging (2025-10-02)
가이드라인 또는 권고문 성격이 강해 설계 기준에 직접 영향을 줄 수 있습니다.
MFDS
[USA] FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment (2025-12-01)
가이드라인 또는 권고문 성격이 강해 설계 기준에 직접 영향을 줄 수 있습니다.
Regulatory preview
Watch-Regulatory 미리보기
| 국가 | 기관 | 주제 | 연도 | 제목 | 설명 | 링크 |
|---|---|---|---|---|---|---|
| Japan | PMDA | Risk Management / RMP | Current | PMDA Review Reports | 심사 보고서와 검토 문서를 통해 실제 규제 판단 흐름을 따라갈 수 있는 PMDA 영문 포털입니다. | 원문 |
| Japan | PMDA | Clinical Trials / GCP | Current | PMDA English RSS Feed | PMDA 영문 업데이트를 가장 넓게 따라가는 기본 피드입니다. AI, 안전성, 심사 관련 문서를 우선 감시할 때 유용합니다. | 원문 |
| Japan | PMDA | Safety / PV | Current | PMDA Drug Safety Information | 약물 안전성, 위해 정보, 시판 후 안전관리 관련 공지를 추적하는 PMDA 영문 포털입니다. | 원문 |
| Japan | PMDA | Risk Management / RMP | 2025 | Report of the PMDA-ATC Pharmacovigilance Seminar 2025 | 세미나 결과 보고 페이지로, PMDA가 post-marketing safety와 RMP를 어떤 내용으로 다뤘는지 확인할 수 있습니다. | 원문 |
| Japan | PMDA | Risk Management / RMP | 2025 | PMDA-ATC Pharmacovigilance Seminar 2025 | PMDA가 pharmacovigilance와 RMP를 어떤 언어로 다루는지 엿볼 수 있는 교육·세미나 페이지입니다. | 원문 |
| Japan | PMDA | AI / Machine Learning | 2025 | Action Plan for the Use of AI in Operations at the PMDA | PMDA가 내부 운영과 심사 역량에서 AI를 어떻게 활용하려는지 보여주는 공식 action plan입니다. | 원문 |
| Japan | PMDA | Clinical Trials / GCP | 2025 | APEC Center of Excellence Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2025 | MRCT와 GCP inspection 관점에서 PMDA가 임상시험과 규제 조화를 어떻게 다루는지 볼 수 있는 세미나 페이지입니다. | 원문 |
| Korea | MFDS | AI / Machine Learning | 2025 | Six AI-related Clinical Trial Guidelines | AI 기반 임상시험에서 실무적으로 참고할 수 있는 식약처 가이드 6종 배포 안내입니다. | 원문 |
Paper preview
Watch-Paper 미리보기
| 국가 | 저널 / 출처 | 주제 | 연도 | 제목 | 설명 | 링크 |
|---|---|---|---|---|---|---|
| Global | Pharmacoepidemiology and drug safety | General Regulatory | 2026 | The Impact of Balance Solution on the Outcomes of Incident Peritoneal Dialysis Patients. | The Impact of Balance Solution on the Outcomes of Incident Peritoneal Dialysis Patients. | 원문 |
| Global | Pharmacoepidemiology and drug safety | General Regulatory | 2026 | Psychotropic Use Among Classroom Teachers in Espírito Santo: A Cross-Sectional Study. | Psychotropic Use Among Classroom Teachers in Espírito Santo: A Cross-Sectional Study. | 원문 |
| Global | Pharmacoepidemiology and drug safety | Safety / PV | 2026 | Performance of the Self-Controlled Case Series for Drug Safety Signal Detection: A Multi-Database Study. | Performance of the Self-Controlled Case Series for Drug Safety Signal Detection: A Multi-Database Study. | 원문 |
| Global | Pharmacoepidemiology and drug safety | General Regulatory | 2026 | Knowledge, Attitudes and Sources of Information About Adverse Drug Reactions-A Survey Study Among Patients and Healthcare Professionals in Poland. | Knowledge, Attitudes and Sources of Information About Adverse Drug Reactions-A Survey Study Among Patients and Healthcare Profe... | 원문 |
| Global | Pharmacoepidemiology and drug safety | General Regulatory | 2026 | Impact of COVID-19 Restrictions on Nationwide Antipsychotic Use: Results From the Trends in Drug Utilization During COVID-19 Pandemic in Turkey (PANDUTI-TR) Study. | Impact of COVID-19 Restrictions on Nationwide Antipsychotic Use: Results From the Trends in Drug Utilization During COVID-19 Pa... | 원문 |
| Global | Pharmacoepidemiology and drug safety | Causal Inference | 2026 | High-Dimensional Propensity Scores for Mitigating Confounding: Implementation Using Primary and Secondary Care Data in Hong Kong. | High-Dimensional Propensity Scores for Mitigating Confounding: Implementation Using Primary and Secondary Care Data in Hong Kong. | 원문 |
| Global | Pharmacoepidemiology and drug safety | AI / Machine Learning | 2026 | Filling the Gaps in Health Data: Using a Machine Learning Approach to Augment Partially Observed Variables Such as Smoking in Claims Data. | Filling the Gaps in Health Data: Using a Machine Learning Approach to Augment Partially Observed Variables Such as Smoking in C... | 원문 |
| Global | Pharmacoepidemiology and drug safety | Data Source / Registry | 2026 | Evaluating Data Quality by Proxy: Can We Evaluate All Dimensions of the European Medicines Agency Data Quality Framework for Registry-Based Post-Authorization Safety Studies? | Evaluating Data Quality by Proxy: Can We Evaluate All Dimensions of the European Medicines Agency Data Quality Framework for Re... | 원문 |
Standards preview
Watch-Standards 미리보기
| 국가 | 기관 | 주제 | 연도 | 제목 | 설명 | 링크 |
|---|---|---|---|---|---|---|
| Global | OHDSI | Methods / Network | Current | OHDSI Home | 커뮤니티 발표, 오픈소스 도구, 네트워크 업데이트를 따라가기 위한 OHDSI 메인 페이지입니다. | 원문 |
| Global | OHDSI | OMOP / Data Model | Current | OHDSI Data Standardization | OMOP CDM과 표준화 전략을 따라가기 위한 OHDSI의 핵심 페이지입니다. | 원문 |
| Global | ICH | Clinical Trials / GCP | Current | Search the Index of ICH Guidelines | ICH 가이드라인 전체를 검색하고 현재 어떤 문서가 어떤 카테고리에 있는지 확인하는 기본 허브입니다. | 원문 |
| Global | ICH | RWE Strategy | Current | ICH Multidisciplinary Guidelines | M 계열 문서와 함께 RWD/RWE, 전자자료, 혁신적 평가 주제가 모일 가능성이 높은 ICH 허브입니다. | 원문 |
| Global | ICH | Clinical Trials / GCP | Current | ICH Efficacy Guidelines | 임상시험 설계와 평가 관련 ICH E 계열 가이드라인을 추적하는 허브입니다. | 원문 |
| Global | CDISC | Submission Standards | Current | CDISC Standards | CDISC 표준 전반을 보는 기본 허브로, SDTM, ADaM, Define-XML 등 제출 표준의 출발점입니다. | 원문 |
| Global | CDISC | RWE Strategy | Current | CDISC Real-World Data | CDISC가 RWD와 observational studies를 어떤 표준 언어로 연결하는지 추적할 수 있는 허브입니다. | 원문 |
| Global | OHDSI | OMOP / Data Model | Unknown | ↓ Skip to Main Content Who We Are Mission, Vision & Values Areas of Focus Who We Serve Collaborators Titan Awards Regional Chapters Website Privacy Policy Notice Updates & News Community News & Update | ↓ Skip to Main Content Who We Are Mission, Vision & Values Areas of Focus Who We Serve Collaborators Titan Awards Regional Chap... | 원문 |
Latest documents
최근 문서
Generalizability Analyses with a Partially Nested Trial Design: The Necrotizing Enterocolitis Surgery Trial.
Generalizability Analyses with a Partially Nested Trial Design: The Necrotizing Enterocolitis Surgery Trial.
Comparison of Lactation Information from Electronic Health Records with Survey Data Across Five US Health Systems.
Comparison of Lactation Information from Electronic Health Records with Survey Data Across Five US Health Systems.
Effect of School Reopenings on Children's Mental Health During COVID-19: Quasi-experimental Evidence from California.
Effect of School Reopenings on Children's Mental Health During COVID-19: Quasi-experimental Evidence from California.
Comparing Area-level Patient Density and Physician Prescribing Preference Instruments for the Effect of Antidiabetics on Adverse Cardiovascular Events Among Medicare Beneficiaries.
Comparing Area-level Patient Density and Physician Prescribing Preference Instruments for the Effect of Antidiabetics on Adverse Cardiovascular Events Among Medicare Beneficiaries.
Longer-term Survival of UK People with Bleeding Disorders Infected by Human Immunodeficiency Virus and/or Hepatitis C Virus Through Contaminated Blood Transfusions.
Longer-term Survival of UK People with Bleeding Disorders Infected by Human Immunodeficiency Virus and/or Hepatitis C Virus Through Contaminated Blood Transfusions.
Neighborhood-level Measures of Structural Racism and Severe Maternal Morbidity Among Black Mothers in California.
Neighborhood-level Measures of Structural Racism and Severe Maternal Morbidity Among Black Mothers in California.
Historical Neighborhood Redlining and Fertility in a Cohort of US Black Women.
Historical Neighborhood Redlining and Fertility in a Cohort of US Black Women.
Test-negative Designs with Various Reasons for Testing: Statistical Bias and Solution.
Test-negative Designs with Various Reasons for Testing: Statistical Bias and Solution.
Adapting Back-calculation Methods to Estimate the Incidence of Tuberculosis.
Adapting Back-calculation Methods to Estimate the Incidence of Tuberculosis.
The Ideal Trial: Defining Causal Estimands that Balance Relevance and Feasibility in Target Trial Emulations and Actual Randomized Trials.
The Ideal Trial: Defining Causal Estimands that Balance Relevance and Feasibility in Target Trial Emulations and Actual Randomized Trials.
Novel Pooling Method for Nonlinear Cohort Analysis and Meta-analysis Estimates: Predicting Health Outcomes from Dietary Changes.
Novel Pooling Method for Nonlinear Cohort Analysis and Meta-analysis Estimates: Predicting Health Outcomes from Dietary Changes.
Considerations for Estimating Causal Effects of Informatively Timed Treatments.
Considerations for Estimating Causal Effects of Informatively Timed Treatments.
Characteristics of United States Food and Drug Administration Drug Recalls Involving Opioid Medications, 2002-2025.
Characteristics of United States Food and Drug Administration Drug Recalls Involving Opioid Medications, 2002-2025.
Assessment of Off-Label Psychotropic Drug Use in Children and Adolescents: A Multi-Center Cross-Sectional Study in China.
Assessment of Off-Label Psychotropic Drug Use in Children and Adolescents: A Multi-Center Cross-Sectional Study in China.
The effect of damp housing on psychological distress: does respiratory health matter?
The effect of damp housing on psychological distress: does respiratory health matter?
Transparency of post-authorisation studies.
Transparency of post-authorisation studies.
Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.
Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.
Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications.
Intraoperative Driving Pressure-Guided High PEEP vs Standard Low PEEP for Postoperative Pulmonary Complications.
A Lay Health Worker-Led Symptom Intervention and Acute Care Use in Older Adults With Cancer: A Randomized Clinical Trial.
A Lay Health Worker-Led Symptom Intervention and Acute Care Use in Older Adults With Cancer: A Randomized Clinical Trial.
Self-Disclosed Use of AI in Research Submissions to BMJ Journals.
Self-Disclosed Use of AI in Research Submissions to BMJ Journals.
Win Ratio Method for Hierarchical Composite Outcomes in Randomized Clinical Trials.
Win Ratio Method for Hierarchical Composite Outcomes in Randomized Clinical Trials.
Author Disclosure of Use of AI in Submissions to 13 JAMA Network Journals.
Author Disclosure of Use of AI in Submissions to 13 JAMA Network Journals.
CONSORT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and impact of paediatric randomised trials.
CONSORT-C 2026 explanation and elaboration: recommendations for enhancing the reporting and impact of paediatric randomised trials.
CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials.
CONSORT-Children and Adolescents (CONSORT-C) 2026 extension statement: enhancing the reporting and impact of paediatric randomised trials.
Recent changes
변경 감지
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
MFDS guideline/page content changed at the same URL.
Regulatory map
규제기관 가이드라인 분류
국가
Japan · 39
South Korea · 34
United States · 6
European Union · 5
Korea · 4
기관
PMDA (Japan) · 39
MFDS (South Korea) · 34
FDA (United States) · 6
EMA (European Union) · 5
MFDS (Korea) · 4
주제
Safety / PV · 39
General Regulatory · 13
AI / Machine Learning · 10
Digital / Device · 6
RWE Strategy · 5
Statistical Methods · 4
Risk Management / RMP · 3
Clinical Trials / GCP · 3
Data Source / Registry · 3
Non-Interventional Design · 1
Causal Inference · 1
발표 연도
Unknown · 66
Current · 3
2025 · 12
2024 · 4
2023 · 1
2021 · 1
2016 · 1
Guideline watch
최근 규제기관 문서
PMDA Review Reports
심사 보고서와 검토 문서를 통해 실제 규제 판단 흐름을 따라갈 수 있는 PMDA 영문 포털입니다.
PMDA English RSS Feed
PMDA 영문 업데이트를 가장 넓게 따라가는 기본 피드입니다. AI, 안전성, 심사 관련 문서를 우선 감시할 때 유용합니다.
PMDA Drug Safety Information
약물 안전성, 위해 정보, 시판 후 안전관리 관련 공지를 추적하는 PMDA 영문 포털입니다.
Report of the PMDA-ATC Pharmacovigilance Seminar 2025
세미나 결과 보고 페이지로, PMDA가 post-marketing safety와 RMP를 어떤 내용으로 다뤘는지 확인할 수 있습니다.
PMDA-ATC Pharmacovigilance Seminar 2025
PMDA가 pharmacovigilance와 RMP를 어떤 언어로 다루는지 엿볼 수 있는 교육·세미나 페이지입니다.
Action Plan for the Use of AI in Operations at the PMDA
PMDA가 내부 운영과 심사 역량에서 AI를 어떻게 활용하려는지 보여주는 공식 action plan입니다.
APEC Center of Excellence Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2025
MRCT와 GCP inspection 관점에서 PMDA가 임상시험과 규제 조화를 어떻게 다루는지 볼 수 있는 세미나 페이지입니다.
Six AI-related Clinical Trial Guidelines
AI 기반 임상시험에서 실무적으로 참고할 수 있는 식약처 가이드 6종 배포 안내입니다.
MFDS Drugs Guideline List
영문 공개 가이드라인 목록 페이지로, 현재 어떤 의약품 관련 가이드가 나와 있는지 추적하는 기본 출발점입니다.
Guidelines on Generative AI Medical Devices
생성형 AI 기반 의료기기의 허가·심사 방향을 설명하는 식약처 발표 자료입니다.
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
의료기기 규제 판단에서 RWE를 어떤 기준으로 받아들일지 정리한 핵심 final guidance입니다.
Predetermined Change Control Plans for AI-Enabled Device Software Functions
AI-enabled 의료기기 소프트웨어의 변경관리와 사전 변경계획을 어떻게 규제에 연결할지 정리한 final guidance입니다.
Reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence
비중재 연구에서 RWD로 RWE를 만들 때 필요한 데이터 품질과 설계 엄밀성을 다루는 EMA 문서입니다.
Real-world evidence
EMA의 RWE 허브 페이지로, 현재 guidance roadmap과 reflection paper, registry-based studies 문서를 함께 추적하기에 좋습니다.
Journey towards a roadmap for regulatory guidance on use of real-world evidence in the EU
EU에서 RWE 규제 가이던스를 어떤 로드맵으로 가져갈지 보여주는 방향성 문서입니다.
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
비중재 연구를 의약품 규제 의사결정 근거로 사용할 때 설계와 편향 통제를 어떻게 볼지 정리한 FDA draft guidance입니다.
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
EHR와 claims 데이터를 규제 목적 근거로 쓸 때 데이터 적합성과 품질을 어떻게 평가할지 다루는 FDA final guidance입니다.
Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products
의약품과 생물학적제제에서 RWD/RWE를 어떻게 제출하고 해석할지 다루는 FDA draft guidance입니다.
Reflection paper on the use of Artificial Intelligence in the medicinal product lifecycle
의약품 생애주기 전반에서 AI를 어떻게 보고, 어디서 규제적 검토가 필요한지 정리한 EMA reflection paper입니다.
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products
레지스트리를 규제 근거로 활용할 때 설계와 운영상 고려점을 다루는 FDA final guidance입니다.
Guideline on registry-based studies
레지스트리 기반 연구를 규제 목적 근거로 사용할 때 필요한 설계와 데이터 품질을 다루는 EMA guideline입니다.
Clinical Trial Statistical Guideline
임상시험 통계 해석과 분석 원칙을 볼 때 여전히 기준 문서로 참고할 수 있는 식약처 자료입니다.
日本語ページはこちら We collect safety information, such as adverse drug reactions, infections caused by use of pharmaceuticals and medical devices and adverse events caused by medical devices from companies an
日本語ページはこちら We collect safety information, such as adverse drug reactions, infections caused by use of pharmaceuticals and medic...
日本語ページはこちら During the review process, PMDA evaluates the quality,efficacy, and safety of drugs, medical devices, and cellular and tissue-based products in light of current scientific and technological
日本語ページはこちら During the review process, PMDA evaluates the quality,efficacy, and safety of drugs, medical devices, and cellular a...
PMDA focus
PMDA 문서 추적
Jump to body HOME 日本語サイト Site map Contact us Font size Standard Large Menu Close Favorite pages Search Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Formats DL About PMDA About PMDA For
Jump to body HOME 日本語サイト Site map Contact us Font size Standard Large Menu Close Favorite pages Search Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Formats DL About PMDA About PMDA Formats DL Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Menu of each service Menu for each of you Menu of each product type Back Reviews and Related Services Outline Consultations Reviews New Modalities and NAMs GLP / GCP / GPSP Compliance Assessments GMP / QMS / GCTP Inspections Assessments to Registered Certification Bodies Regulatory Information・Early Consideration Public comments Post-marketing Safety Measures Outline Scientific Research and Analyses Provision of Information Regarding Post-marketing Safety Regulatory Information Public comments Relief Services for Adverse Health Effects Outline Public comments Regulatory Science/The Science Board/Standard Development Outline of Regulatory Science Recent Publications by PMDA Staff The Science Board Measures for advanced science and technology RS Projects Across Multi-Offices in PMDA Outline Japanese Pharmacopoeia Medical Device Standards International Activities Outline For Industry - for development in Japan International Harmonization Bilateral Arrangements and Cooperation Cooperation with Asia Asia Training Center Overseas Office Public comments Back For Regulatory Authorities Regulations & Services of PMDA Training Seminar Reviews Safety Measures - Outline Safety Measures - RMP Relief Services for Adverse Health Effects GLP / GCP / GPSP Compliance Assessments GMP / QMS / GCTP Inspections Japanese Pharmacopeia Medical Device Standards Regulatory Information Information about Approved Products in Japan New D
Regulatory Science/The Science Board/Standard Development
What's new All What's new All March 2, 2026 JP New PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (March 2026) posted February 20, 2026 Other Recent Publications by PMDA Staff updated Back number
Master File System
日本語ページはこちら The Drug Master File (DMF) System, allows the manufacturers of Active Pharmaceutical Ingredients (APIs) to submit the detailed information (manufacturing methods, data, etc.) of APIs to the Review Authority (PMDA).The registered information (manufacturing methods, data, etc.) is quoted as the necessary information for an approval review of the pharmaceutical products in which APIs is used. DMF is reviewed at the time of the approval review for the pharmaceutical products quoting DMF. At the time of DMF registration, PMDA checks whether it is written in the correct format, e.g., minimum required items are included (application) and data is attached (CTD M3).
Companion Diagnostics
日本語ページはこちら Links to major regulatory information of Companion Diagnostics（CDx）. Regulations and Notifications Drug-Agnostic Companion Diagnostics Application for Partial Changes Based on Evaluation of Applicability to Drug-agnostic Companion Diagnostics, etc. (EGFR gene mutations in patients with non-small cell lung cancer)[242KB] September 5, 2025 PSB/PED Notification No.
Medical Devices
Jump to body HOME 日本語サイト Site map Contact us Font size Standard Large Menu Close Favorite pages Search Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Formats DL About PMDA About PMDA Formats DL Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Menu of each service Menu for each of you Menu of each product type Back Reviews and Related Services Outline Consultations Reviews New Modalities and NAMs GLP / GCP / GPSP Compliance Assessments GMP / QMS / GCTP Inspections Assessments to Registered Certification Bodies Regulatory Information・Early Consideration Public comments Post-marketing Safety Measures Outline Scientific Research and Analyses Provision of Information Regarding Post-marketing Safety Regulatory Information Public comments Relief Services for Adverse Health Effects Outline Public comments Regulatory Science/The Science Board/Standard Development Outline of Regulatory Science Recent Publications by PMDA Staff The Science Board Measures for advanced science and technology RS Projects Across Multi-Offices in PMDA Outline Japanese Pharmacopoeia Medical Device Standards International Activities Outline For Industry - for development in Japan International Harmonization Bilateral Arrangements and Cooperation Cooperation with Asia Asia Training Center Overseas Office Public comments Back For Regulatory Authorities Regulations & Services of PMDA Training Seminar Reviews Safety Measures - Outline Safety Measures - RMP Relief Services for Adverse Health Effects GLP / GCP / GPSP Compliance Assessments GMP / QMS / GCTP Inspections Japanese Pharmacopeia Medical Device Standards Regulatory Information Information about Approved Products in Japan New D
Jump to body HOME 日本語サイト Site map Contact us Font size Standard Large Menu Close Favorite pages Search Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Formats DL About PMDA About PMDA For
Jump to body HOME 日本語サイト Site map Contact us Font size Standard Large Menu Close Favorite pages Search Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Formats DL About PMDA About PMDA Formats DL Safety Alert & Recalls/ Review Reports/ Package Inserts etc. Menu of each service Menu for each of you Menu of each product type Back Reviews and Related Services Outline Consultations Reviews New Modalities and NAMs GLP / GCP / GPSP Compliance Assessments GMP / QMS / GCTP Inspections Assessments to Registered Certification Bodies Regulatory Information・Early Consideration Public comments Post-marketing Safety Measures Outline Scientific Research and Analyses Provision of Information Regarding Post-marketing Safety Regulatory Information Public comments Relief Services for Adverse Health Effects Outline Public comments Regulatory Science/The Science Board/Standard Development Outline of Regulatory Science Recent Publications by PMDA Staff The Science Board Measures for advanced science and technology RS Projects Across Multi-Offices in PMDA Outline Japanese Pharmacopoeia Medical Device Standards International Activities Outline For Industry - for development in Japan International Harmonization Bilateral Arrangements and Cooperation Cooperation with Asia Asia Training Center Overseas Office Public comments Back For Regulatory Authorities Regulations & Services of PMDA Training Seminar Reviews Safety Measures - Outline Safety Measures - RMP Relief Services for Adverse Health Effects GLP / GCP / GPSP Compliance Assessments GMP / QMS / GCTP Inspections Japanese Pharmacopeia Medical Device Standards Regulatory Information Information about Approved Products in Japan New D