Watch-Regulatory
Watch-Regulatory
FDA, EMA, PMDA, 식약처 문서를 국가·기관·주제·연도 기준으로 표 형태로 정리합니다.
Sources
기관 요약
PMDA · 39
MFDS · 30
FDA · 6
EMA · 5
Topics and years
주제 / 연도 요약
Safety / PV · 33
General Regulatory · 12
AI / Machine Learning · 9
Digital / Device · 6
RWE Strategy · 5
Statistical Methods · 4
Unknown · 58
2025 · 12
2024 · 4
Current · 3
2016 · 1
2021 · 1
Filter
Structured table
규제기관 문서 표
| 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 |
| Korea | MFDS | General Regulatory | 2025 | MFDS Drugs Guideline List | 영문 공개 가이드라인 목록 페이지로, 현재 어떤 의약품 관련 가이드가 나와 있는지 추적하는 기본 출발점입니다. | 원문 |
| Korea | MFDS | AI / Machine Learning | 2025 | Guidelines on Generative AI Medical Devices | 생성형 AI 기반 의료기기의 허가·심사 방향을 설명하는 식약처 발표 자료입니다. | 원문 |
| United States | FDA | RWE Strategy | 2025 | Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | 의료기기 규제 판단에서 RWE를 어떤 기준으로 받아들일지 정리한 핵심 final guidance입니다. | 원문 |
| United States | FDA | AI / Machine Learning | 2025 | Predetermined Change Control Plans for AI-Enabled Device Software Functions | AI-enabled 의료기기 소프트웨어의 변경관리와 사전 변경계획을 어떻게 규제에 연결할지 정리한 final guidance입니다. | 원문 |
| European Union | EMA | RWE Strategy | 2025 | 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. | 원문 |
| European Union | EMA | RWE Strategy | 2025 | Real-world evidence | EMA의 RWE 허브 페이지로, 현재 guidance roadmap과 reflection paper, registry-based studies 문서를 함께 추적하기에 좋습니다. | 원문 |
| European Union | EMA | RWE Strategy | 2025 | 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. | 원문 |
| United States | FDA | Non-Interventional Design | 2024 | 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. | 원문 |
| United States | FDA | Data Source / Registry | 2024 | 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. | 원문 |
| United States | FDA | RWE Strategy | 2024 | 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. | 원문 |
| European Union | EMA | AI / Machine Learning | 2024 | 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. | 원문 |
| United States | FDA | Data Source / Registry | 2023 | 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. | 원문 |
| European Union | EMA | Data Source / Registry | 2021 | Guideline on registry-based studies | 레지스트리 기반 연구를 규제 목적 근거로 사용할 때 필요한 설계와 데이터 품질을 다루는 EMA guideline입니다. | 원문 |
| Korea | MFDS | Statistical Methods | 2016 | Clinical Trial Statistical Guideline | 임상시험 통계 해석과 분석 원칙을 볼 때 여전히 기준 문서로 참고할 수 있는 식약처 자료입니다. | 원문 |
| Japan | PMDA | Safety / PV | Unknown | 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... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | 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... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | The Yellow Letter / Blue Letter | 日本語ページはこちら To prevent health hazards associated with the use of drugs, it is important that post-marketing reports of adverse d... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Strategy of SAKIGAKE by MHLW | On June 17th, 2014, the Ministry of Health, Labour and Welfare (MHLW) announced the "Strategy of SAKIGAKE" to lead the world in... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Scientific Research and Analyses | 日本語ページはこちら PMDA conducts research and reviews of the collected information through scientific analyses, interviews with compani... | 원문 |
| Japan | PMDA | Causal Inference | Unknown | Safety Measures - RMP | 日本語ページはこちら Summary of risk management plan (RMP) In order to ensure the safety of drugs, it is important to assess measures for... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Safety Alert & Recalls/ Review Reports/ Package Inserts etc. | Jump to body Pmda Pharmaceuticals and Medical Devices Agency ここから本文です。 Safety Alert & Recalls / Review Reports / Package Insert... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Revisions of PRECAUTIONS | 日本語ページはこちら Revisions of PRECAUTIONS in drug package inserts PRECAUTIONS in package inserts include information such as WARNING,... | 원문 |
| Japan | PMDA | Digital / Device | Unknown | Reviews and Related Services | What's new All What's new All February 24, 2026 Devices New Software as a Medical Device (SaMD) page updated February 20, 2026... | 원문 |
| Japan | PMDA | General Regulatory | Unknown | 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 Feb... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Regulatory Information・Early Consideration | 日本語ページはこちら Links to pages containing key guidance and guidelines related to PMDA operations. PMDA's Early Consideration General... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Regulatory Information | 日本語ページはこちら Links to major regulatory information of Database Survey. Regulations and Notifications Safety Measures Drugs Medica... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Regenerative Medical Products | 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/... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Provision of Information Regarding Post-marketing Safety | 日本語ページはこちら Information related to drugs, medical devices, regenerative medical products, and in vitro diagnostics, PMDA medical... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Post-marketing Safety Measures | What's new All What's new All February 25, 2026 Devices New Revisions of PRECAUTIONS (Medical Devices): Perfluoron posted Febru... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | PMDA Medical Safety Information | 日本語ページはこちら Among the medical incident reports and adverse drug reaction/malfunction reports that have been collected to date, i... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | PMDA Alert for Proper Use of Drugs | 日本語ページはこちら PMDA Alert for Proper Use of Drugs provides information on the proper use of pharmaceutical products for which patie... | 원문 |
| Japan | PMDA | Statistical Methods | Unknown | Office of Advanced Evaluation with Electronic Data | 日本語ページはこちら In recent drug development, the use of data-based quantitative information such as those using modeling and simulati... | 원문 |
| Japan | PMDA | Digital / Device | Unknown | New Modalities and NAMs | 日本語ページはこちら The PMDA actively promotes initiatives aimed at the development of new modalities and novel evaluation technologies... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | New 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/... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | 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/... | 원문 |
| Japan | PMDA | Digital / Device | Unknown | 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 th... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | 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/... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | 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/... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | 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/... | 원문 |
| Japan | PMDA | General Regulatory | Unknown | Japanese Pharmacopoeia | About JP JP History and Legal Status[69.9KB] PMDA and JP{5.9KB] Basic Principles for Preparation of JP (Abstract)[286KB] Establ... | 원문 |
| Japan | PMDA | Clinical Trials / GCP | Unknown | GMP / QMS / GCTP Inspections | 日本語ページはこちら When drug products, medical devices or cellular and tissue-based products are manufactured, all product batches shou... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | GLP / GCP / GPSP Compliance Assessments | 日本語ページはこちら PMDA conducts inspections and data integrity assessments in relation to applications for marketing approval, re-exam... | 원문 |
| Japan | PMDA | Statistical Methods | Unknown | Drugs Reviews In the review of drug applications, PMDA reviewers, who have degrees in pharmaceutical science, medicine, veterinary medicine, physical science, biostatistics, or other specialties, form | Drugs Reviews In the review of drug applications, PMDA reviewers, who have degrees in pharmaceutical science, medicine, veterin... | 원문 |
| Japan | PMDA | Safety / PV | Unknown | Consultations | Consultations PMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and cellular... | 원문 |
| Japan | PMDA | Digital / Device | Unknown | 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 Com... | 원문 |
| Japan | PMDA | Digital / Device | Unknown | Assessments to Registered Certification Bodies | 日本語ページはこちら A person who intends to market a medical device or in-vitro diagnostic reagent which is designated by the Minister o... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | 전체 30 건, 현재페이지 1 /3 게시물 검색 조건 선택 제목 내용 keyword 검색 [식약처-26-001] 신기술의료기기 현장 도입 기간 대폭 단축 식품의약품안전처 2026-02-27 [식약처-25-030] 국제적 공인과 신뢰 기반의 K-식의약 글로벌 진출 확대 식품의약품안전처 2026-02-27 [식약처-25-027] 국가 필수의약품 안정공급의 제도 | 전체 30 건, 현재페이지 1 /3 게시물 검색 조건 선택 제목 내용 keyword 검색 [식약처-26-001] 신기술의료기기 현장 도입 기간 대폭 단축 식품의약품안전처 2026-02-27 [식약처-25-030] 국제적 공인과... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | [USA] Texas bill that would outlaw lab-grown meat passes Senate committee, heads to Senate vote (2025-05-06) | [USA] Texas bill that would outlaw lab-grown meat passes Senate committee, heads to Senate vote (2025-05-06) Registration Date... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | [USA] FSIS Removal of Pumped Bacon Sampling Regulations (2025-07-01) | [USA] FSIS Removal of Pumped Bacon Sampling Regulations (2025-07-01) Registration Date 2025-07-02 Hit 2198 AGENCY: Food Safety... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | [USA] FSIS Issues Public Health Alert for Ground Beef Products Due to Possible E. Coli O157:H7 Contamination (2025-06-03) | [USA] FSIS Issues Public Health Alert for Ground Beef Products Due to Possible E. Coli O157:H7 Contamination (2025-06-03) Regis... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | [USA] FDA releases results on economically motivated adulteration (short weighting) in seafood (2025-09-02) | [USA] FDA releases results on economically motivated adulteration (short weighting) in seafood (2025-09-02) Registration Date 2... | 원문 |
| South Korea | MFDS | AI / Machine Learning | Unknown | [USA] FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment (2025-12-01) | [USA] FDA Expands Artificial Intelligence Capabilities with Agentic AI Deployment (2025-12-01) Registration Date 2025-12-03 Hit... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | [USA] American Heart Association Scientific Sessions 2025, Long-term use of melatonin supplements to support sleep may have negative health effects (2025-11-03) | [USA] American Heart Association Scientific Sessions 2025, Long-term use of melatonin supplements to support sleep may have neg... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | [UK] FSA launches consultation on proposed ban of Bisphenol A (BPA) and related chemicals in food packaging (2025-10-02) | [UK] FSA launches consultation on proposed ban of Bisphenol A (BPA) and related chemicals in food packaging (2025-10-02) Regist... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | [UK] DHSC Landmark junk food ad ban to protect kid’s health (2026-01-05) | [UK] DHSC Landmark junk food ad ban to protect kid’s health (2026-01-05) Registration Date 2026-01-06 Hit 471 Children will be... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | [Australia] FSANZ has updated the Compendium of Microbiological Criteria for Food (2025-08-04) | [Australia] FSANZ has updated the Compendium of Microbiological Criteria for Food (2025-08-04) Registration Date 2025-08-04 Hit... | 원문 |
| South Korea | MFDS | Statistical Methods | Unknown | Total 7 Articles, Present Page 1 /1 All Subject Contents 검색어 Search 7 Guideline on Evaluation of New Extended Release(ER) Preparations[Guidance for Industry] Guideline_on_Evaluation_of_New_Extended_Re | Total 7 Articles, Present Page 1 /1 All Subject Contents 검색어 Search 7 Guideline on Evaluation of New Extended Release(ER) Prepa... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | Total 65 Articles, Present Page 1 /7 All Subject Contents 검색어 Search 65 Advisory Meeting Outcomes on Moderna COVID-19 Vaccine [Press Release, May 10, 2021] (5.10) Advisory Meeting Outcomes on Moderna | Total 65 Articles, Present Page 1 /7 All Subject Contents 검색어 Search 65 Advisory Meeting Outcomes on Moderna COVID-19 Vaccine [... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | Total 59 Articles, Present Page 1 /6 All Subject Contents 검색어 Search 59 2024 Drug Approval Report The MFDS published the “2024Drug Approval Report” for the purpose of informing the current trends of d | Total 59 Articles, Present Page 1 /6 All Subject Contents 검색어 Search 59 2024 Drug Approval Report The MFDS published the “2024D... | 원문 |
| South Korea | MFDS | AI / Machine Learning | Unknown | Total 5059 Articles, Present Page 2 /506 All Subject Contents 검색어 Search 5049 [USA] Bill would prohibit Red 40 in foods sold in Tennessee school lunch programs(2025-04-08) NASHVILLE, Tenn. (WKRN) — Ab | Total 5059 Articles, Present Page 2 /506 All Subject Contents 검색어 Search 5049 [USA] Bill would prohibit Red 40 in foods sold in... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Total 35 Articles, Present Page 1 /4 게시물 검색 조건 선택 All Subject Contents keyword search MFDS Achieves Highest Maturity Level in Regulatory System by WHO 2022-12-02 Make sure to check KF mark when buying | Total 35 Articles, Present Page 1 /4 게시물 검색 조건 선택 All Subject Contents keyword search MFDS Achieves Highest Maturity Level in R... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | Total 22 Articles, Present Page 1 /3 All Subject Contents 검색어 Search 22 Novarex 1. Business: (1) Dietary Supplements(Vitamin, Probiotics, Omega-3, Saw palmetto, Eye health and Beauty, Weight managemen | Total 22 Articles, Present Page 1 /3 All Subject Contents 검색어 Search 22 Novarex 1. Business: (1) Dietary Supplements(Vitamin, P... | 원문 |
| South Korea | MFDS | Digital / Device | Unknown | Total 175 Articles, Present Page 1 /18 All Subject Contents 검색어 Search 175 2024 Medical Device Approval Report The MFDS published the “2024 Medical Device Approval Report” with a purpose to introduce | Total 175 Articles, Present Page 1 /18 All Subject Contents 검색어 Search 175 2024 Medical Device Approval Report The MFDS publish... | 원문 |
| South Korea | MFDS | AI / Machine Learning | Unknown | Total 122 Articles, Present Page 1 /11 게시물 검색 조건 선택 All Subject Contents keyword search Food truck site visit 2024-05-27 Meeting on improvement strategy of food for patients 2024-05-23 Afras 2024 2024 | Total 122 Articles, Present Page 1 /11 게시물 검색 조건 선택 All Subject Contents keyword search Food truck site visit 2024-05-27 Meetin... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Reuters(US), France tightens infant milk rules after recalls (2026-01-31) | Reuters(US), France tightens infant milk rules after recalls (2026-01-31) Registration Date 2026-02-03 Hit 778 PARIS, Jan 31 (R... | 원문 |
| South Korea | MFDS | AI / Machine Learning | Unknown | Regulations | Total 40 Articles, Present Page 1 /4 All Subject Contents 검색어 Search 40 Medical Device Good Manufacturing Practice (GMP) Regula... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Regulations | Total 53 Articles, Present Page 1 /6 All Subject Contents 검색어 Search 53 2024 Annal Report of National Lot Release The Ministry... | 원문 |
| South Korea | MFDS | General Regulatory | Unknown | Regulations | Total 48 Articles, Present Page 1 /5 All Subject Contents 검색어 Search 48 Korean Pharmacopoeia (Twelfth Edition) Korean Pharmacop... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Regulations | Total 49 Articles, Present Page 1 /5 All Subject Contents 검색어 Search 49 Regulation on Recognition of Functional Ingredient and... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Regional Office of Food and Drug Safety | Regional Office of Food and Drug Safety Seoul Regional Office of Food and Drug Safety General Affairs Division Food Safety Mana... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Overview Overview of Pharmaceutical Approval Process Approve pharmaceuticals whose safety, efficacy, and quality are identified (including pharmaceutical ingredients) through technological review and | Overview Overview of Pharmaceutical Approval Process Approve pharmaceuticals whose safety, efficacy, and quality are identified... | 원문 |
| South Korea | MFDS | Safety / PV | Unknown | Notification to WTO TBT and WTO SPS | Total 25 Articles, Present Page 1 /3 All Subject Contents 검색어 Search 25 [G/SPS/N/KOR/702] Enforcement Rule of the Special Act o... | 원문 |