MFDS 지침·고시 아카이브

국소 안과용 의약품 품질 가이드라인

의약품 허가·심사 조정협의체 운영안내서

세포치료제 세포은행 평가 가이드라인

허가외 사용 의약품 평가 절차

의약품용 한약재 수입 업무 가이드라인

수입요건확인 면제대상 물품 중 의약품등의 추천요령 업무처리 지침

바이오의약품 사전 GMP 평가 지침

합성 올리고뉴클레오티드 의약품의 임상시험 시 비임상시험 가이드라인

(GRP-MaPP-심사기준-01)의약품 임상시험계획(변경)승인 검토서 작성기준

신세포암 보조요법으로 의약품 개발 시 고려사항(민원인 안내서)

한약(생약)제제 전성분 분석 정보자료집

한약(생약) 품질관리를 위한 유전자 분석법 마련 표준절차

신약 품목허가·심사 업무절차

제형별 사전 GMP 평가 운영 지침

바이오의약품 품목허가 등 민원 관련 접수, 검토 및 처리 업무절차

의료기기 소프트웨어 밸리데이션 가이드라인

「의약품 병용금기 성분 등의 지정에 관한 규정」 고시 전문(제2026-52호)

Guideline for Drafting and Reviewing Revisions to Herbal Medicine (Crude Drug) Specifications

Procedure for Reviewing Sanctions Related to NIFDS Research and Development Projects

Guideline for Preparing Quality Data for Herbal Medicine (Crude Drug) Extracts

Casebook on Improving Look-Alike Pharmaceutical Containers, Packaging and Labeling

Guideline on Approval and Review of Molecular Genetic Histocompatibility Antigen (HLA) Test Reagents

Procedure for Pharmaceutical Inspections of Drug Importers

「의료기기 제조 및 품질관리 관련 기관 지정 등에 관한 규정」(제2026-47호)

「의료기기 제조 및 품질관리 기준」(제2026-46호)

Questions and Answers on Stability Testing Standards for Pharmaceuticals

Operational Guideline for Recall and Disposal of Pharmaceuticals

Casebook on Comparative Dissolution Testing of Herbal Medicinal Products

Guideline on Approval and Review of Digital Medical Device Change Management Plans

Guideline on Clinical Trials of Herbal Medicinal Products: General Considerations

Guideline on Tumorigenicity Evaluation of Stem Cell Therapy Products

Administrative Notice of Proposed Partial Amendment to the Regulation on Designation of Contraindicated Drug Combinations, etc. (MFDS Public Notice No. 2026-292)

GMP Evaluation Procedure for Biopharmaceutical Contract Manufacturing Organizations

Administrative Notice of a Proposed Regulation on Designation of Institutions Related to Medical Device Manufacturing and Quality Management (MFDS Public Notice No. 2026-283)

Administrative Notice of a Proposed Partial Amendment to the Standards for Medical Device Manufacturing and Quality Management (MFDS Public Notice No. 2026-282)

Operation of Drug Review Guidelines, etc.

Establishment, Revision and Operation of the Good Review Practice Manual of Policies and Procedures (GRP-MaPP)

Procedure for Handling Consultations by the Drug Evaluation Department

Organization and Operation of the Drug Review Advisory Panel

Procedure for In-Depth Review (Peer Review) of Pharmaceuticals

Regulation on Reporting Production and Export/Import Performance of Pharmaceuticals, etc. (MFDS Notice No. 2026-42, 5 June 2026)

Administrative Notice of a Proposed Partial Amendment to the Regulation on Pharmaceutical Approval, Notification and Review

Administrative Notice of a Proposed Partial Amendment to the Regulation on Designation of Drugs of Abuse Concern (MFDS Public Notice No. 2026-275, 5 June 2026)

Guideline on Quality and Nonclinical Evaluation for Clinical Trials of Live Biotherapeutic Products

2025 Report on Renewal of Pharmaceutical Product Approvals

Nonclinical Study Guideline for Herbal Medicinal Products

Administrative Notice of a Proposed Partial Amendment to the Regulation on Approval and Review of Biological Products (MFDS Public Notice No. 2026-251, 28 May 2026)

Procedure for New Drug Approval and Review

Procedure for Biosimilar Product Approval and Review

2025년 의약외품 허가보고서

2025년 의약품 허가보고서

매개변수기반 출하 적용 의약품 품질평가자료 심사 시 일반적 고려사항

제2차 의약품 안전관리 2차년도('26년) 시행계획

생물학적제제등 품목허가심사 규정 고시 전문(제2026-29호, 2026.4.6.)

「생물학적제제 기준 및 시험방법」 전문(식품의약품안전처 고시 제2026-28호, 2026.4.2.)

생물의약품의 국제표준품 확보 및 관리 절차

Full Text of the Standards and Test Methods for Quasi-Drugs (MFDS Notice No. 2026-15, 25 February 2026)