国立医薬品食品衛生研究所生化学部

国立医薬品食品衛生研究所へのリンク

放射性医薬品に関する国内外の文書等（一覧）

医薬品・医療機器｜厚生労働省
独立行政法人医薬品医療機器総合機構

タイトル	発行年	URL
「診断用放射性医薬品の臨床評価方法に関するガイドライン」について	2012	https://www.pmda.go.jp/files/000157190.pdf

EMA ｜ European Medicines Agency

タイトル	発行年	URL
Guideline on the non-clinical requirements for radiopharmaceuticals (Draft)	2018	https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-non-clinical-requirements-radiopharmaceuticals-first-version_en.pdf
Guideline on core SmPC and Package Leaflet for (⁶⁸Ge/⁶⁸Ga) generator	2017	https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-package-leaflet-68ge/68ga-generator-first-version_en.pdf
Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (^99mTc) albumin	2016	https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-package-leaflet-nanocolloidal-technetium-99mtc-albumin-first-version_en.pdf
Guideline on core SmPC and Package Leaflet for sodium fluoride (¹⁸F)	2015	https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-smpc-package-leaflet-sodium-fluoride-18f_en.pdf
Guideline on core SmPC and package leaflet for (⁹⁹Mo/^99mTc) generator	2014	https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-core-summary-product-characteristics-smpc-package-leaflet-99mo/99mtc-generator_en.pdf
Guideline on core SmPC and Package Leaflet for technetium (^99mTc) sestamibi	2013	https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-core-summary-product-characteristics-package-leaflet-technetium-99mtc-sestamibi_en.pdf
Core SmPC for radiopharmaceuticals	2010	https://www.ema.europa.eu/en/documents/scientific-guideline/core-summary-product-characteristics-radiopharmaceuticals_en.pdf
Radiopharmaceuticals based on monoclonal antibodies	1991	https://www.ema.europa.eu/en/documents/scientific-guideline/radiopharmaceuticals-based-monoclonal-antibodies_en.pdf
Radiopharmaceuticals	1990	https://www.ema.europa.eu/en/documents/scientific-guideline/radiopharmaceuticals_en.pdf

FDA ｜ Food and Drug Administration

タイトル	発行年	URL
Guidance for Industry Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations	2019	https://www.fda.gov/media/129547/download
Guidance for Industry Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities	2018	https://www.fda.gov/media/102637/download
Guidance for Industry Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities	2018	https://www.fda.gov/media/102615/download
Guidance for Industry Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations	2018	https://www.fda.gov/media/107641/download
Guidance FDA Oversight of PET Drug Products Questions and Answers	2012	https://www.fda.gov/media/82911/download
Guidance Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs	2012	https://www.fda.gov/media/83077/download
Guidance for Industry Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals	2011	https://www.fda.gov/media/72237/download
Guidance PET Drugs — Current Good Manufacturing Practice (CGMP) (Small Entity Compliance Guide)	2011	https://www.fda.gov/files/drugs/published/PET-Drugs--Current-Good-Manufacturing-Practice-%28CGMP%29--Small-Entity-Compliance-Guide.pdf
Guidance PET Drug Applications — Content and Format for NDAs and ANDAs	2011	https://www.fda.gov/media/72271/download
Guidance for Industry New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products	2009	https://www.fda.gov/media/77679/download
Guidance PET Drugs — Current Good Manufacturing Practice (CGMP)	2009	https://www.fda.gov/media/71013/download
Guidance for Industry CGMP for Phase 1 Investigational Drugs	2008	https://www.fda.gov/media/70975/download

Health Canada

タイトル	発行年	URL
Regulatory roadmap for radiopharmaceutical (Schedule C) drugs in Canada	2021	https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/regulatory-roadmap-schedule-c.html
Guidance document Radiopharmaceuticals, Kits, and Generators: Submission Information for Schedule C Drugs	2019	https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/drug/radiopharmaceuticals-schedule-c/sch_c-ann_c_document_en_2019-07.pdf
Annex 3B to the Good manufacturing practices guide – Positron-emitting radiopharmaceuticals	2006	https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gui-0071/gui-0071-eng.pdf
Draft Guidance for Industry Preparation of the Quality Information for Radiopharmaceuticals (Schedule C Drugs) using the Quality Information Summary-Radiopharmaceuticals (QIS-R) and Certified Product Information Document	2001	https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/draft-guidance-industry-preparation-quality-information-radiopharmaceuticals.html

WHO ｜ World Health Organization

タイトル	発行年	URL
International Atomic Energy Agency (IAEA)/World Health Organization (WHO) guideline on good manufacturing practices for investigational radiopharmaceutical products（draft）	2021	https://cdn.who.int/media/docs/default-source/medicines/ norms-and-standards/current-projects/ qas21_878_iaea_who_gmp_for_radiopharmaceutical _products.pdf?sfvrsn=6285a50a_3
International Atomic Energy Agency (IAEA)/WHO guideline on good manufacturing practices for radiopharmaceutical products	2019	https://apps.who.int/iris/bitstream/handle/10665/330869/ DI333-395-409-eng.pdf?sequence=1&isAllowed=y
International Atomic Energy Agency (IAEA)/WHO guideline on good manufacturing practices for radiopharmaceutical products（draft）	2019	https://www.who.int/medicines/areas/quality_safety/ quality_assurance/QAS18.782_Rev1_IAEA_WHO _gmp_for_radiopharmaceutical_products.pdf?ua=1

IAEA ｜ International Atomic Energy Agency

タイトル	発行年	URL
IAEA-TECDOC-1856 Quality Control in the Production of Radiopharmaceuticals	2018 (Emended 2019)	https://www-pub.iaea.org/MTCD/Publications/PDF/TE-1856web.pdf
IAEA-TECDOC-1782 Good Practice for Introducing Radiopharmaceuticals for Clinical Use	2016	https://www-pub.iaea.org/MTCD/Publications/PDF/TE-1782_web.pdf
IAEA HUMAN HEALTH SERIES No. 33 Quality Management Audits in Nuclear Medicine Practices Second Edition	2015	https://www-pub.iaea.org/MTCD/Publications/PDF/Pub1683Web-68161172.pdf

「日本薬局方」ホームページ｜厚生労働省

タイトル	発行年	URL
日本薬局方（厚生労働省）		https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000066530.html
第十七改正日本薬局方（PMDA）		https://www.pmda.go.jp/rs-std-jp/standards-development/jp/0013.html
日本薬局方と関連情報（衛研）		https://jpdb.nihs.go.jp/kyokuhou/index.html
放射性医薬品基準（衛研）		http://www.nihs.go.jp/kanren/iyaku/radiopharma_std.html

EP | European Pharmacopoeia

タイトル	発行年	URL
European pharmacopeia 10.0 english index	2019	https://www.edqm.eu/sites/default/files/medias/fichiers/ European_Pharmacopoeia/The_European_Pharmacopoeia/ European_Pharmacopoeia_10th_Edition/Index/ european_pharmacopeia_10.0_english_index.pdf
Guide for the elaboration of monographs on radiopharmaceutical preparations	2018	https://www.edqm.eu/sites/default/files/ guide_-_guide_for_the_elaboration_of_monographs_on_radio-pharmaceutical_preparations_-_october_2018.pdf

USP | United States Pharmacopeia

タイトル	発行年	URL
(821) Radioactivity	2015	https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/key-issues/general-chapter-821-proposed-revision.pdf
(823) Radiopharmaceuticals for Positron Emission Tomography—Compounding	2011	https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/key-issues/uspgeneralchapter823.pdf
(825) Radiopharmaceuticals-Preparation, Compounding, Dispensing, and Repackaging	2019	https://www.usp.org/sites/default/files/usp/document/our-work/chemical-medicines/proposed-gc-825.pdf
(1821) Radioactivity—Theory and Practice	2015	https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/key-issues/general-chapter-1821-proposed-revision.pdf
(1823) Positron Emission Tomography Drugs—Information	2015	https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/key-issues/general-chapter-1823-proposed-revision.pdf

IP | The International Pharmacopoeia

タイトル	発行年	URL
The International Pharmacopoeia, Ninth Edition 2019	2019	https://apps.who.int/phint/en/p/docf/

令和３年５月３１日現在

戻る

トップへ戻るボタン