[{"_1":2,"_125":-5,"_126":-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","f40b3208-916b-4e75-9469-974b2d07c9eb","regulationData",{"_36":33,"_37":38,"_121":122,"_123":124},"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,"_100":101,"_102":103,"_104":105,"_106":107,"_108":109,"_110":111,"_112":113,"_114":115,"_116":117,"_118":-5,"_119":120},"title","Peraturan Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2025 tentang Tata Laksana Persetujuan Obat Pengembangan Baru","short_title","Peraturan Badan Pengawas Obat dan Makanan Nomor 24 Tahun 2025","number","24","year","2025","published_date","2025-08-13","effective_date","2025-08-20","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 Obat Pengembangan Baru","subject_matter","abstract","\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n

Tata Laksana - Persetujuan - Obat - Pengembangan Baru
2025
Peraturan Badan Pengawas Obat dan Makanan NO. 24, BN 2025 (613); 37 hlm
Peraturan Badan Pengawas Obat dan Makanan TENTANG Tata Laksana Persetujuan Obat Pengembangan Baru
ABSTRAK:	\n \n bahwa pengaturan mengenai tata laksana persetujuan\r\nobat pengembangan baru sebagaimana diatur dalam\r\nPeraturan Kepala Badan Pengawas Obat dan Makanan\r\nNomor 16 Tahun 2015 tentang Tata Laksana dan\r\nPenilaian Obat Pengembangan Baru sudah tidak sesuai\r\ndengan kebutuhan hukum serta perkembangan ilmu\r\npengetahuan dan teknologi di bidang obat, sehingga\r\nperlu diganti \n Dasar hukum peraturan ini adalah PP Nomor 28 Tahun 2024; Perpres Noor 80 Tahun 2017; PErka BPOM Nomor 24 Tahun 2017 sebagaimana telah beberapa kali diubah terakhir dengan Peraturan BPOM Nomor 23 Tahun 2025; Peraturan BPOM Nomor 21 Tahun 2020 sebagaimana telah diubah dengan Peraturan BPOM Nomor 13 Tahun 2022 \n PEraturan ini mengatur mengenai permohonan penilaian obat pengembangan baru; penilaian obat pengembangan baru; keputusan atas penilaian obat pengembangan baru; masa berlaku surat keterangan obat pengembangan baru; perubahan dokumen; dan pelaporan \n \n
CATATAN:	\n \n Peraturan Badan Pengawas Obat dan Makanan ini mulai berlaku pada tanggal 20 Agustus 2025. \n 37 hlm; hlm 1 sd 10 (batang tubuh); hlm 11 sd 37 (lampiran) \n \n

","regulatory_relationship","Peraturan ini mencabut: 1. Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 16 Tahun 2015 tentang Tata Laksana dan Penilaian Obat Pengembangan Baru (Berita Negara Republik Indonesia Tahun 2015 Nomor 1854). Peraturan ini mengubah: (-)","scope_and_parties","policy_content","Peraturan ini bertujuan untuk memastikan bahwa obat pengembangan baru memenuhi standar khasiat, keamanan, dan mutu sebelum beredar. Badan Pengawas Obat dan Makanan (BPOM) bertanggung jawab atas pengawasan ini, sesuai dengan Peraturan Presiden Nomor 80 Tahun 2017. Peraturan ini menggantikan Peraturan Kepala BPOM Nomor 16 Tahun 2015 yang dianggap tidak sesuai dengan perkembangan ilmu pengetahuan dan teknologi. Pelaku usaha yang ingin mendapatkan persetujuan untuk obat pengembangan baru harus mengajukan permohonan secara elektronik dan memenuhi persyaratan dokumen yang ditetapkan. BPOM akan melakukan verifikasi dan penilaian terhadap dokumen yang diajukan. Jika dokumen lengkap, pelaku usaha harus membayar biaya penilaian sebagai penerimaan negara bukan pajak. Penilaian dilakukan oleh tim penilai OPB yang dapat melibatkan tim ahli. Keputusan atas penilaian dapat berupa persetujuan atau penolakan. Surat Keterangan OPB berlaku selama lima tahun dan dapat diperpanjang. Pelaku usaha juga dapat mengajukan perubahan dokumen jika terdapat perubahan pada mutu OPB.","transitional_provisions","1. Permohonan Persetujuan OPB yang telah diajukan sebelum berlakunya Peraturan Badan ini tetap diproses sesuai dengan Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 16 Tahun 2015 tentang Tata Laksana dan Penilaian Obat Pengembangan Baru.","sanctions","(-)","revokes",[94],{"_95":96,"_97":98,"_36":99},"text","Peraturan Kepala Badan Pengawas Obat dan Makanan Nomor 16 Tahun 2015 tentang Tata Laksana dan Penilaian Obat Pengembangan Baru","link","https://peraturan.go.id/id/peraturan-bpom-no-16-tahun-2015","5002323b-a01f-4df7-9965-6ef3f5f976bf","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 24 OF 2025
CONCERNING
PROCEDURES FOR APPROVAL OF NEW DRUG DEVELOPMENT

BY THE GRACE OF GOD ALMIGHTY

HEAD OF THE FOOD AND DRUG MONITORING AGENCY,

\n\n \n \n

Considering:

that to ensure new drug development before being circulated has met the standards and/or requirements of efficacy, safety, and quality, it is necessary to have procedures for approval of new drug development;
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 carries out the function of implementing pre-circulation and post-circulation supervision;
that the regulation regarding the procedures for approval of new drug development as stipulated in the Regulation of the Head of the Food and Drug Monitoring Agency Number 16

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