[{"_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","f4add29c-5f70-416d-8cfc-21f93da01666","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,"_72":73,"_74":75,"_76":77,"_78":79,"_80":-5,"_81":82,"_83":84,"_85":-5,"_86":87,"_88":89,"_90":91,"_92":93,"_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 8 Tahun 2024 tentang Tata Laksana Persetujuan Pelaksanaan Uji Klinik","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 8 Tahun 2024","number","8","year","2024","published_date","2024-05-15","effective_date","2024-05-21","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],{"_55":70,"_56":71,"_58":-5},"10e70ff8-158d-4e9e-849e-554938c706d9","Pelayanan Kesehatan","tags",[],"location","Badan Pengawas Obat dan Makanan","place_of_enactment","Jakarta","theme","Tata Laksana Persetujuan Pelaksanaan Uji Klinik","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n


2024
Peraturan Badan Pengawas Obat dan Makanan NO. 8, BN 2024 (272); 121 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Tata Laksana Persetujuan Pelaksanaan Uji Klinik
ABSTRAK:	\n \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 21 Mei 2024. \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.3.4991 Tahun 2004 tentang Inspeksi Uji Klinik; 2. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 21 Tahun 2015 tentang Tata Laksana Persetujuan Uji Klinik (Berita Negara Republik Indonesia Tahun 2015 Nomor 1987).","scope_and_parties","policy_content","Peraturan ini bertujuan untuk melindungi masyarakat dari penggunaan obat dan produk terkait yang tidak memenuhi persyaratan keamanan, khasiat, dan mutu. Badan Pengawas Obat dan Makanan (BPOM) memiliki fungsi pengawasan sebelum dan selama produk beredar. Peraturan ini menggantikan ketentuan sebelumnya untuk menyesuaikan dengan perkembangan ilmu pengetahuan dan teknologi. Uji klinik harus dilakukan untuk memastikan keamanan dan khasiat produk, termasuk obat, obat bahan alam, obat kuasi, suplemen kesehatan, kosmetik, dan pangan olahan. Uji klinik dibagi menjadi prapemasaran dan pascapemasaran, dan harus dilakukan sesuai dengan pedoman Cara Uji Klinik yang Baik (CUKB). Persetujuan pelaksanaan uji klinik (PPUK) harus diperoleh dari BPOM sebelum uji klinik dilaksanakan, kecuali untuk pangan olahan dan kosmetik.","transitional_provisions","1. Sponsor atau ORK yang telah melaksanakan Uji Klinik sebelum berlakunya Peraturan Badan ini harus menyesuaikan dengan ketentuan dalam Peraturan Badan ini paling lama 6 (enam) bulan terhitung sejak Peraturan Badan ini diundangkan.","sanctions","1. Pelanggaran terhadap ketentuan dalam Pasal 5 ayat (1), Pasal 6 ayat (1), Pasal 23 ayat (1), Pasal 24 ayat (1), Pasal 26 ayat (1), Pasal 27 ayat (1), Pasal 27 ayat (2), Pasal 31 ayat (2), dan/atau Pasal 31 ayat (4) dikenai sanksi administratif berupa: a. peringatan; b. peringatan keras; c. penangguhan Uji Klinik; dan/atau d. penghentian pelaksanaan Uji Klinik.","revokes",[94,100],{"_95":96,"_97":98,"_36":99},"text","Perka BPOM No. 21 Tahun 2015 tentang Tata Laksana Persetujuan Uji Klinik","link","https://peraturan.bpk.go.id/Details/286418/perka-bpom-no-21-tahun-2015","57928b02-4476-43d2-8dd6-13f86e9f6e3b",{"_95":101,"_97":102},"Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor HK.00.05.3.4991 Tahun 2004 tentang Inspeksi Uji Klinik","","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

REGULATION OF THE FOOD AND DRUG MONITORING AGENCY
NUMBER 8 OF 2024
CONCERNING
PROCEDURES FOR APPROVAL OF CLINICAL TRIAL IMPLEMENTATION

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG MONITORING AGENCY,

\n\n \n \n

Considering:

that the public needs to be protected from the use of drugs, natural drugs, quasi drugs, health supplements, cosmetics, and processed food that do not meet the requirements for safety, efficacy/benefit, and quality;
that under certain conditions, the safety and efficacy/benefit of drugs, natural drugs, quasi drugs, health supplements, cosmetics, and processed food must be proven scientifically through clinical trials;
that based on the provisions of Article 3 paragraph (1) letter d of Presidential Regulation Number 80 of 2017 concerning the Food and Drug Monitoring Agency, the Food and Drug Monitoring Agency has the function of carrying out pre-market

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