{"id":428,"date":"2025-11-25T01:30:00","date_gmt":"2025-11-24T18:30:00","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/11\/25\/panel-pakar-industri-menimbang-manfaat-risiko-dan-kesiapan-cnpv-bagian-ii\/"},"modified":"2025-11-25T01:30:00","modified_gmt":"2025-11-24T18:30:00","slug":"panel-pakar-industri-menimbang-manfaat-risiko-dan-kesiapan-cnpv-bagian-ii","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/11\/25\/panel-pakar-industri-menimbang-manfaat-risiko-dan-kesiapan-cnpv-bagian-ii\/","title":{"rendered":"Panel Pakar Industri Menimbang Manfaat, Risiko, dan Kesiapan CNPV: Bagian II"},"content":{"rendered":"<div id=\"block-content\"> <astro-island uid=\"Zr25Ad\" prefix=\"r84\" component-url=\"\/_astro\/figure.ROEGDD4M.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_key&quot;:(0,&quot;f2de79c5b785&quot;),&quot;_type&quot;:(0,&quot;figure&quot;),&quot;alignment&quot;:(0,&quot;left&quot;),&quot;alt&quot;:(0,&quot;speech bubbles concept 3d illustration | Image Credit: \u00a9 frender - stock.adobe.com - modified in Canva by Chris Cole, PharmTech.&quot;),&quot;asset&quot;:(0,{&quot;_ref&quot;:(0,&quot;image-5ff5599fcde9b6bacc3c63daf4ca31fe336562d2-1200x627-png&quot;),&quot;_type&quot;:(0,&quot;reference&quot;)}),&quot;disableLightBox&quot;:(0,false),&quot;imageFit&quot;:(0,&quot;crop&quot;),&quot;imgcaption&quot;:(1,((0,{&quot;_key&quot;:(0,&quot;e45f372cba16&quot;),&quot;_type&quot;:(0,&quot;block&quot;),&quot;children&quot;:(1,((0,{&quot;_key&quot;:(0,&quot;fcefbbc2936d&quot;),&quot;_type&quot;:(0,&quot;span&quot;),&quot;marks&quot;:(1,()),&quot;text&quot;:(0,&quot;speech bubbles concept 3d illustration | Image Credit: \u00a9 frender - stock.adobe.com - modified in Canva by Chris Cole, PharmTech.&quot;)}))),&quot;markDefs&quot;:(1,()),&quot;style&quot;:(0,&quot;normal&quot;)}))),&quot;medias&quot;:(0,null),&quot;uploadAudio&quot;:(0,null),&quot;upload_doc&quot;:(0,null),&quot;widthP&quot;:(0,30)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;FigurePlugin&quot;,&quot;value&quot;:true}\"\/><\/p>\n<p class=\"\"><em>Catatan Editor: Pendapat yang dikemukakan di sini tidak mencerminkan pendapat perusahaan\/perusahaan tempat pembicara bekerja.<\/em><br \/><em>Mengakses <astro-island uid=\"1LRQw8\" prefix=\"r72\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;bc581ad591a0&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;part I of this discussion&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;fbe980a51754&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/industry-expert-panel-weighs-cnpv-benefits-risks-and-readiness-part-i&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;fbe980a51754&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">bagian I dari diskusi ini<!--astro:end--><\/astro-island>.<\/em><br \/>Memeriksa <em>cakupan tambahan dan perspektif pakar industri dalam &#8220;<astro-island uid=\"2i7pHX\" prefix=\"r73\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;ecb08c97ed10&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;The Regulatory Crucible: Risk, Resource Drain, and the Hidden Trade-Offs of the CNPV Pilot Program&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;2e425e3f4b86&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/the-regulatory-crucible-risk-resource-drain-and-the-hidden-trade-offs-of-the-cnpv-pilot-program&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;2e425e3f4b86&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Wadah Peraturan: Risiko, Pengurasan Sumber Daya, dan Pengorbanan Tersembunyi dari Program Percontohan CNPV<!--astro:end--><\/astro-island>&#8221; Dan &#8220;<astro-island uid=\"xngOF\" prefix=\"r74\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;d3e0a1c162d6&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Ready or Not: Biopharma Alignment for CNPV\u2019s Rapid Review&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;33c8dfb9f72a&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/ready-or-not-biopharma-alignment-for-cnpvs-rapid-review&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;33c8dfb9f72a&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Siap atau Tidak: Penyelarasan Biopharma untuk Tinjauan Cepat CNPV<!--astro:end--><\/astro-island>.\u201d<\/em><\/p>\n<p class=\"\"><em>Dan lihat &#8220;<astro-island uid=\"Z8kbRH\" prefix=\"r75\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;519c6fb77052&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;How the FDA Commissioner\u2019s National Priority Vouchers Reshape Manufacturing, Pricing &amp; Global Strategy&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;5784542b322d&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmexec.com\/view\/fda-commissioner-national-priority-vouchers-manufacturing-pricing-global-strategy&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;5784542b322d&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Bagaimana Voucher Prioritas Nasional Komisaris FDA Membentuk Kembali Manufaktur, Penetapan Harga &#038; Strategi Global<!--astro:end--><\/astro-island>,&#8221; serta &#8220;<astro-island uid=\"Z17EDXo\" prefix=\"r76\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;45c72ad39eef&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Winners &amp; Losers: What the First FDA Commissioner\u2019s National Priority Vouchers Tell Us About Early Movers vs. Late Movers\\&quot;&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;4042accf86ff&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmexec.com\/view\/fda-commissioner-national-priority-vouchers-early-late-movers&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;4042accf86ff&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Pemenang &#038; Pecundang: Apa yang Diceritakan oleh Voucher Prioritas Nasional Komisaris FDA Pertama Tentang Penggerak Awal vs. Penggerak Terlambat&#8221;<!--astro:end--><\/astro-island><\/em> <em>dari kolega kami di Pharmaceutical Executive.<\/em><\/p>\n<p>Pada pertengahan November 2025, <em>Grup Teknologi Farmasi<\/em> mengadakan diskusi dengan enam pakar industri bio\/farmasi untuk lebih memahami dampak\u2014baik yang diketahui maupun yang potensial\u2014dari program percontohan Voucher Prioritas Nasional (CNPV) Komisioner FDA (1). Program ini menawarkan &#8220;peluang yang belum pernah terjadi sebelumnya untuk mengurangi waktu peninjauan aplikasi obat dan produk biologis atau suplemen khasiat dari 10-12 bulan menjadi hanya 1-2 bulan&#8221; (2,3). Meskipun Komisaris FDA Marty Makary, MD, MPH, menyebut CNPV sebagai \u201cpendekatan yang masuk akal\u201d yang memanfaatkan diskusi \u201cgaya dewan tumor\u201d untuk memberikan \u201clebih banyak penyembuhan dan perawatan yang bermakna bagi masyarakat Amerika\u201d (3), para ahli di bidang kesehatan masyarakat dan kebijakan peraturan (1,4-6), memperingatkan bahwa percepatan ini mungkin mengorbankan standar keselamatan dan tanggung jawab fiskal yang ditetapkan. Berikut ini adalah rekap diskusi paruh kedua, yang dimoderatori oleh Eric Langer, presiden dan mitra pengelola, BioPlan Associates.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Langer: Apakah CNPV merupakan gimmick yang akan terjebak dalam kompleksitas proses<\/strong><\/h2>\n<p class=\"\"><span style=\"text-decoration: underline;\">Aloka Srinivasan, prinsipal dan mitra pengelola di Raaha LLC:<\/span> Voucher prioritas telah dikeluarkan oleh FDA sejak lama, sebagian besar untuk penyakit anak yang langka. Ini hanyalah perpanjangan dari proses. FDA memiliki proses yang kini dapat mereka kembangkan untuk mencakup obat-obatan dalam negeri yang kebutuhannya belum terpenuhi. Saya merasa perusahaan inovator yang telah mengajukan entitas kimia baru ke (berbagai badan pengatur) akan mampu menavigasi proses ini. Namun, perusahaan obat generik, yang biasanya tidak terbiasa berkomunikasi dengan Badan seperti yang dilakukan oleh sponsor obat baru, kini perlu mengubah pola pikir mereka dan siap untuk melakukannya. Mereka juga perlu memahami pentingnya pengajuan bergilir, yang berarti bahwa pekerjaan pengembangan produk dan proses serta peninjauan berjalan secara paralel. Ini jelas bukan gimmick, namun prosesnya mungkin terasa rumit bagi sponsor yang tidak terbiasa bekerja dengan paradigma ini. Sekali lagi, seperti tinjauan prioritas, kita akan mengetahui apakah hal ini bermanfaat hanya ketika proses dimulai dengan penyerahan beberapa dokumen untuk produk yang dipilih.<\/p>\n<p class=\"\"><span style=\"text-decoration: underline;\">Henrik Johanning, wakil presiden senior, Kualitas &#038; Strategi, Epista Life Science: <\/span>Tidak. Ini adalah program percontohan yang sangat terfokus, bukan jebakan birokrasi atau kedok. FDA telah membangun tim \u201cpeninjauan cepat\u201d yang berdedikasi dan lintas fungsi serta pekerjaan CMC dan pelabelan yang dimuat di depan untuk menghindari penyerahan produk secara tepat. Ini adalah kecepatan untuk program siap pakai, bukan jalan pintas dalam hal kualitas.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Langer: Di manakah manfaat on-shoring?<\/strong><\/h2>\n<p class=\"\"><span style=\"text-decoration: underline;\">Srinivasan:<\/span> Manfaat on-shoring sangat tinggi untuk obat generik dan biosimilar. Mereka sekarang akan mendapatkan peluang besar untuk berkomunikasi dengan FDA sebelum pengajuan mereka. Dalam kasus obat generik yang tidak rumit, hal ini merupakan suatu kemewahan yang jarang terjadi, karena sponsor produk tersebut hanya memiliki sedikit cara untuk berkomunikasi dengan Agensi sebelum diserahkan. Amandemen Biaya Pengguna Obat Generik (7) memungkinkan korespondensi terkontrol, yang rumit dan memakan waktu, dan terkadang tanggapan FDA menghasilkan lebih banyak pertanyaan dan jawaban. Sebagian besar komunikasi untuk obat generik terjadi setelah penyerahan, melalui permintaan informasi, surat tinjauan disiplin, dan terkadang surat tanggapan lengkap\u2026 Berdasarkan voucher, sponsor akan mendapatkan banyak kesempatan untuk mendiskusikan produk dan proses dengan Agensi sebelum penyerahan berkas, dan harapannya adalah pada saat mereka menyerahkan berkas, semoga sebagian besar permasalahan telah terselesaikan.<\/p>\n<p class=\"\"><span style=\"text-decoration: underline;\">Yohanes: <\/span>On-shoring adalah salah satu kriteria seleksi eksplisit. FDA menggunakan program ini untuk mengarahkan manufaktur tingkat lanjut, terutama produk suntik steril dan produk biologis, kembali ke AS. Hal ini bertujuan untuk memperkuat ketahanan rantai pasokan, dan juga untuk membangun kembali kapasitas farmasi dalam negeri setelah puluhan tahun melakukan pengiriman ke Asia dan Eropa Timur. Program ini bertujuan untuk:<\/p>\n<ul class=\"my-2\">\n<li class=\"ml-8 list-disc\">Mengurangi ketergantungan strategis pada pemasok API dan produk steril di satu wilayah, non-AS.<\/li>\n<li class=\"ml-8 list-disc\">Menjaga, melindungi, dan \u201cmenumbuhkan\u201d pengetahuan manufaktur yang penting di berbagai bidang seperti biologi, terapi sel, dan sistem aseptik tingkat lanjut.<\/li>\n<li class=\"ml-8 list-disc\">Mendorong modernisasi dengan menggunakan teknologi manufaktur berkelanjutan atau teknologi sekali pakai yang berbasis di AS.<\/li>\n<li class=\"ml-8 list-disc\">Meningkatkan ketangkasan peraturan, karena fasilitas yang berbasis di AS lebih mudah bagi FDA untuk memeriksa, memantau, dan memberikan dukungan selama peningkatan skala atau remediasi.<\/li>\n<li class=\"ml-8 list-disc\">Mendorong keuntungan ekonomi, mendukung pekerjaan biomanufaktur dalam negeri dan infrastruktur sejalan dengan kebijakan industri AS yang lebih luas.<\/li>\n<\/ul>\n<p class=\"\">Jadi, manfaat on-shoring bukan hanya sekedar ketahanan. Ini adalah penyeimbangan kembali yang strategis <em>Di mana<\/em>maupun <em>Bagaimana<\/em>obat-obatan dibuat.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Langer: Bagaimana jika seseorang memproduksi dengan pendekatan ini dan menjual persetujuannya?<\/strong><\/h2>\n<p class=\"\"><span style=\"text-decoration: underline;\">Yohanes: <\/span>Itu tidak mungkin terjadi. Voucher tidak dapat dipindahtangankan. Mereka terikat pada produk dan sponsor tertentu. Sekalipun kepemilikannya berubah, pengawasan FDA dan kewajiban transfer teknologi tetap ada.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Langer: Bagaimana dengan obat praklinis lain yang kalah karena tidak \u201cmenang?\u201d<\/strong><\/h2>\n<p class=\"\"><span style=\"text-decoration: underline;\">Yohanes: <\/span>Mereka mempunyai akses penuh terhadap jalur-jalur yang telah dipercepat (Fast Track, Breakthrough, Priority Review, Accelerated Approval). Voucher ini hanya menambah satu jalur lagi untuk program-program yang sangat matang dan selaras secara strategis.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Langer: Bisakah FDA benar-benar melakukan peninjauan dalam 4 minggu?<\/strong><\/h2>\n<p class=\"\"><span style=\"text-decoration: underline;\">Yohanes: <\/span>Kadang-kadang. Jika berkas sudah lengkap dan bersih. Target 4-8 minggu mengasumsikan tinjauan pra-pengajuan dan CMC yang sempurna. FDA dapat memperluas jangka waktunya ketika kompleksitas menuntutnya.<\/p>\n<p class=\"\"><span style=\"text-decoration: underline;\">Rory Budihandojo, konsultan praktik manufaktur yang baik dan independen:<\/span> Tidak jelas secara logistik bagaimana FDA dapat menyediakan sumber daya yang diperlukan untuk tinjauan singkat\/intens ini tanpa berdampak pada program tinjauan FDA lainnya (misalnya, dapat mengalihkan sumber daya dari program tinjauan standar reguler FDA ke program tinjauan yang dipercepat ini). Oleh karena itu, hal ini juga dapat berdampak pada terapi yang saat ini sedang ditinjau, termasuk potensi alokasi sumber daya dari program tinjauan prioritas FDA lainnya, seperti Voucher Tinjauan Prioritas (PRV), yang mempercepat peninjauan menjadi 6 bulan, bukan 10 bulan.<\/p>\n<p class=\"\">Saran lain adalah agar FDA bekerja sama dengan pihak berwenang lainnya (misalnya, MHRA) dalam melakukan peninjauan, memanfaatkan sumber daya lain dan mencoba menyelaraskan proses peninjauan intra-lembaga, serupa dengan program saling pengakuan FDA dalam memanfaatkan pemeriksaan fasilitas lembaga lain. Meskipun demikian, gaya inspeksi FDA mungkin berbeda dibandingkan dengan lembaga lain (misalnya, biasanya seorang inspektur MHRA memiliki pengalaman industri, sementara beberapa inspektur FDA mungkin tidak memiliki pengalaman industri atau gelar sains, yang seperti \u201cmengetahui cara membaca tentang mengemudi mobil tidak selalu berarti orang tersebut dapat mengemudikan mobil\u201d).<\/p>\n<p class=\"\"><strong>Referensi<\/strong><\/p>\n<ol class=\"my-2\">\n<li class=\"ml-8 list-decimal\">FDA. <astro-island uid=\"Z2cGiw6\" prefix=\"r77\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;913649b35782&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Commissioner's National Priority Voucher (CNPV) Pilot Program&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;3a9bb4981b10&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/www.fda.gov\/industry\/commissioners-national-priority-voucher-cnpv-pilot-program.&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;3a9bb4981b10&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Program Percontohan Voucher Prioritas Nasional Komisaris (CNPV).<!--astro:end--><\/astro-island>. Diakses 18 November 2025.<\/li>\n<li class=\"ml-8 list-decimal\">Dorsey, D; Belanda, S. <astro-island uid=\"271Rfk\" prefix=\"r78\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;d42756af6c09&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;A Tale of Three Vouchers&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;6ec52b451416&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/www.bhfs.com\/insight\/a-tale-of-three-vouchers\/&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;6ec52b451416&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Kisah Tiga Voucher<!--astro:end--><\/astro-island>. <em>BHFS.com<\/em>. 29 September 2025.<\/li>\n<li class=\"ml-8 list-decimal\">FDA. <astro-island uid=\"Z14vj0y\" prefix=\"r79\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;505b7aa16c05&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Commissioner's National Priority Voucher (CNPV) Pilot Program&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;12c974805a8b&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/www.fda.gov\/industry\/commissioners-national-priority-voucher-cnpv-pilot-program.&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;12c974805a8b&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Program Percontohan Voucher Prioritas Nasional Komisaris (CNPV).<!--astro:end--><\/astro-island>. Diakses 18 November 2025.<\/li>\n<li class=\"ml-8 list-decimal\">Dokter untuk Amerika. <astro-island uid=\"1Kavae\" prefix=\"r80\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;96bd68679f8b&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;FDA Commissioner\u2019s National Priority Vouchers Will Endanger Americans&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;42ea34606de3&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/doctorsforamerica.org\/sr-npv\/&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;42ea34606de3&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Voucher Prioritas Nasional Komisaris FDA Akan Membahayakan Orang Amerika<!--astro:end--><\/astro-island>. Siaran Pers. 20 Juni 2025.<\/li>\n<li class=\"ml-8 list-decimal\">Eglovitchm, J. <astro-island uid=\"ZgV57\" prefix=\"r81\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;081f651603e7&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Questions Remain as FDA Opens Submissions for New Priority Voucher Program&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;e58f5ec6ecd3&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/www.raps.org\/news-and-articles\/news-articles\/2025\/7\/questions-remain-as-fda-opens-submissions-for-new&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;e58f5ec6ecd3&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Masih Ada Pertanyaan Saat FDA Membuka Pengajuan untuk Program Voucher Prioritas Baru<!--astro:end--><\/astro-island>. <em>RAPS.org<\/em>. 24 Juli 2025.<\/li>\n<li class=\"ml-8 list-decimal\">Emond, S; Ollendorf, D. <astro-island uid=\"Z1LK9Nl\" prefix=\"r82\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;cc3541490017&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;How to Make One Line in the FDA Commissioner's New Drug Review Program Into a Force for Affordable Access for Patients&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;eadd49f40342&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC12492479\/&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;eadd49f40342&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Bagaimana Membuat Satu Baris dalam Program Tinjauan Obat Baru Komisaris FDA Menjadi Kekuatan untuk Akses Terjangkau bagi Pasien<!--astro:end--><\/astro-island>. <em>Kesehatan Aff Sch<\/em>. 2025;3(10):qxaf182.<\/li>\n<li class=\"ml-8 list-decimal\">FDA. <astro-island uid=\"Z1U2G9O\" prefix=\"r83\" component-url=\"\/_astro\/external-link.WtEnJL32.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_type&quot;:(0,&quot;@span&quot;),&quot;_key&quot;:(0,&quot;243c6241756b&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;Generic Drug User Fee Amendments&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;2b5651e87d60&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;blank&quot;:(0,true),&quot;href&quot;:(0,&quot;https:\/\/www.fda.gov\/industry\/fda-user-fee-programs\/generic-drug-user-fee-amendments&quot;),&quot;nofollow&quot;:(0,true)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;2b5651e87d60&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Perubahan Biaya Pengguna Obat Generik<!--astro:end--><\/astro-island>. Diakses 21 November 2025.<\/li>\n<\/ol><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Catatan Editor: Pendapat yang dikemukakan di sini tidak mencerminkan pendapat perusahaan\/perusahaan tempat pembicara bekerja.Mengakses bagian I dari diskusi ini.Memeriksa cakupan tambahan dan perspektif pakar industri dalam &#8220;Wadah Peraturan: Risiko, Pengurasan Sumber Daya, dan Pengorbanan Tersembunyi dari Program Percontohan CNPV&#8221; Dan &#8220;Siap atau Tidak: Penyelarasan Biopharma untuk Tinjauan Cepat CNPV.\u201d Dan lihat &#8220;Bagaimana Voucher Prioritas Nasional [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":429,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-428","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Panel Pakar Industri Menimbang Manfaat, Risiko, dan Kesiapan CNPV: Bagian II - 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