[{"_1":2,"_128":-5,"_129":-5},"loaderData",{"_3":4,"_28":29,"_30":31},"root",{"_5":6,"_7":-5,"_8":9},"locale","en","session","ENV",{"_10":11,"_12":13,"_14":15,"_16":17,"_18":19,"_20":21,"_22":23,"_24":25,"_26":27},"APP_ENV","production","APP_URL","https://veritask.ai","GA_MEASUREMENT_ID","G-X1BV3QBZEM","META_PIXEL_ID","4698743733686194","TIKTOK_PIXEL_IDS","D8A3HTBC77U9J3L243V0","CLARITY_PROJECT_ID","wn9rn7xb4l","AMPLITUDE_API_KEY","74a0c7cc1509a379d3647ec140dd375","MIDTRANS_CLIENT_KEY","Mid-client-hwjEU5pmwAKVMbIA","MIDTRANS_SNAP_URL","https://app.midtrans.com/snap/snap.js","routes/$locale",{"_5":6},"routes/$locale.search-engine.regulation.$regulationId",{"_32":33,"_34":35},"regulationId","edaacf2b-3961-463b-bb2f-438fd085acac","regulationData",{"_36":33,"_37":38,"_124":125,"_126":127},"regulation_id","overview",{"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_60":61,"_62":63,"_67":68,"_75":76,"_77":78,"_79":80,"_81":82,"_83":-5,"_84":85,"_86":87,"_88":-5,"_89":90,"_91":92,"_93":94,"_95":96,"_103":104,"_105":106,"_107":108,"_109":110,"_111":112,"_113":114,"_115":116,"_117":118,"_119":120,"_121":-5,"_122":123},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2022 tentang Pedoman Uji Toksisitas Praklinik secara In Vivo","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 10 Tahun 2022","number","10","year","2022","published_date","2022-05-18","effective_date","2022-05-19","status_id","3611a577-44a0-41ad-986d-7457e14f52ff","status",{"_55":52,"_56":57,"_58":59},"id","name","Berlaku","description","Peraturan yang masih berlaku dan memiliki kekuatan hukum yang mengikat","type_id","6f5779f5-e2ea-448d-8bb0-b22517233239","type",{"_55":61,"_56":64,"_65":66},"Peraturan Badan Pengawas Obat dan Makanan","short_name","Peraturan BPOM","subjects",[69,72],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan",{"_55":73,"_56":74,"_58":-5},"52ab02bc-b4c7-47db-becc-c90c58185c43","Standar & Pedoman Teknis","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Pedoman Uji Toksisitas Praklinik secara In Vivo","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2022
Peraturan Badan Pengawas Obat dan Makanan NO. 10, BN.2022/No.490, peraturan.go.id: 6 hlm.
Peraturan Badan Pengawas Obat dan Makanan TENTANG Pedoman Uji Toksisitas Praklinik secara In Vivo
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 19 Mei 2022. \n \n

","regulatory_relationship","Peraturan ini mencabut:\n1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 7 Tahun 2014 tentang Pedoman Uji Toksisitas Nonklinik secara In Vivo (Berita Negara Republik Indonesia Tahun 2014 Nomor 875).","scope_and_parties","policy_content","Peraturan Badan Pengawas Obat dan Makanan ini mengatur tentang Pedoman Uji Toksisitas Praklinik secara In Vivo. Latar belakang peraturan ini adalah untuk menjamin keamanan pemaparan suatu zat pada manusia melalui uji toksisitas praklinik secara in vivo. Tujuannya adalah untuk mempelajari efek kumulatif dosis yang dapat menimbulkan efek toksik, karsinogenik, teratogenik, mutagenik, dan efek lain yang berpotensi menimbulkan risiko kesehatan.\n\nKetentuan substansial dalam peraturan ini meliputi:\n\n1. Pelaku usaha atau lembaga penelitian/riset wajib melakukan Uji Toksisitas untuk menjamin keamanan obat dan makanan, yang meliputi Obat jadi, Obat Tradisional, Obat Kuasi, Suplemen Kesehatan, Kosmetika, dan Pangan Olahan.\n2. Untuk Obat Tradisional, Obat Kuasi, dan Suplemen Kesehatan, selain persetujuan komisi etik, diperlukan persetujuan pelaksanaan uji praklinik dari BPOM.\n3. Pedoman Uji Toksisitas digunakan sebagai acuan bagi evaluator BPOM, pelaku usaha, dan lembaga penelitian/riset.","transitional_provisions","Protokol Uji Toksisitas dan/atau data toksisitas yang telah diajukan sebelum berlakunya Peraturan Badan ini, tetap diproses berdasarkan Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 7 Tahun 2014 tentang Pedoman Uji Toksisitas Nonklinik secara In Vivo.","sanctions","(-)","revokes",[97],{"_98":99,"_100":101,"_36":102},"text","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 7 Tahun 2014 tentang Pedoman Uji Toksisitas Nonklinik secara In Vivo","link","https://peraturan.go.id/id/peraturan-bpom-no-7-tahun-2014","f5468e2f-e2c3-45b0-a533-7f11b64cc88d","revoked_by",[],"partially_revokes",[],"partially_revoked_by",[],"amends",[],"amended_by",[],"partially_amends",[],"partially_amended_by",[],"establishes",[],"established_by",[],"constitutional_review","is_verified",false,"english_excerpt","\n

STATE GAZETTE
REPUBLIC OF INDONESIA

REGULATION OF THE FOOD AND DRUG CONTROL AGENCY
NUMBER 10 OF 2022
ABOUT
GUIDELINES FOR IN VIVO PRECLINICAL TOXICITY TESTING

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG CONTROL AGENCY,

\n\n \n \n

Considering:

that to ensure the safety of exposure to a substance
in humans, it is necessary to carry out preclinical toxicity tests
in vivo to study the cumulative effects of doses
that can cause toxic effects in humans, carcinogenic
, teratogenic, mutagenic effects and other effects that
potentially pose health risks to humans;
that the Regulation of the Head of the Food and Drug
Agency Number 7 of 2014 concerning Guidelines for
Non-Clinical Toxicity Testing In Vivo is no longer in accordance
with legal needs and the development of science
and technology so it needs to be replaced;
that based on the provisions of Article 3 paragraph (1) letter d of
Presi

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