{"id":473,"date":"2025-12-20T02:47:55","date_gmt":"2025-12-19T19:47:55","guid":{"rendered":"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/"},"modified":"2025-12-20T02:47:55","modified_gmt":"2025-12-19T19:47:55","slug":"direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025","status":"publish","type":"post","link":"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/","title":{"rendered":"Direktur EMA Melihat Perubahan Perundang-undangan sebagai Puncak Tahun 2025"},"content":{"rendered":"<div id=\"block-content\"> <astro-island uid=\"1XVULP\" prefix=\"r64\" component-url=\"\/_astro\/figure.ZRD0rU0l.js\" component-export=\"default\" renderer-url=\"\/_astro\/client.4AZqD4Tw.js\" props=\"{&quot;value&quot;:(0,{&quot;_key&quot;:(0,&quot;1cc4c0d58261&quot;),&quot;_type&quot;:(0,&quot;figure&quot;),&quot;alignment&quot;:(0,&quot;left&quot;),&quot;alt&quot;:(0,&quot;Concept of EMA European Medicines Agency. Drugs evaluation and quality control department. | Image Credit: \u00a9wladimir1804 -stock.adobe.com&quot;),&quot;asset&quot;:(0,{&quot;_ref&quot;:(0,&quot;image-04bde34a65def76dbd22cdb5f9da9b2ca04f810b-1280x720-jpg&quot;),&quot;_type&quot;:(0,&quot;reference&quot;)}),&quot;disableLightBox&quot;:(0,true),&quot;imageFit&quot;:(0,&quot;crop&quot;),&quot;imgcaption&quot;:(1,((0,{&quot;_key&quot;:(0,&quot;586926fb077d&quot;),&quot;_type&quot;:(0,&quot;block&quot;),&quot;children&quot;:(1,((0,{&quot;_key&quot;:(0,&quot;636b468c2285&quot;),&quot;_type&quot;:(0,&quot;span&quot;),&quot;marks&quot;:(1,()),&quot;text&quot;:(0,&quot;Concept of EMA European Medicines Agency. Drugs evaluation and quality control department. | Image Credit: \u00a9wladimir1804 -stock.adobe.com&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=\"\">Pada 19 Desember 2025, Emer Cooke, direktur eksekutif Badan Obat Eropa (EMA), menerbitkan ringkasan pencapaian badan tersebut pada tahun 2025, yang menandai tiga dekade sejak didirikan. Di antara keberhasilan EMA adalah merekomendasikan 104 obat baru sepanjang tahun, dengan hampir 40% mengandung zat aktif baru (1).<\/p>\n<p class=\"\">Peristiwa terbesar pada tahun 2025, menurut Cooke, adalah <astro-island uid=\"C3gBX\" prefix=\"r58\" 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;0e3936074f8e&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;agreement&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;6d899bc30585&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/european-parliament-revamps-pharmaceutical-policy-framework&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;6d899bc30585&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">perjanjian<!--astro:end--><\/astro-island>    antara Komisi Eropa (EC), Parlemen Eropa, dan Dewan Uni Eropa untuk mengubah undang-undang farmasi (2), <astro-island uid=\"1gD7vC\" prefix=\"r59\" 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;f54a779ddf66&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;which will allow EMA&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;987dacfe6c61&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.pharmtech.com\/view\/ema-calls-new-eu-pharma-legislation-most-significant-in-two-decades&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;987dacfe6c61&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">yang akan memungkinkan EMA<!--astro:end--><\/astro-island>    untuk menyederhanakan prosedurnya (3).<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Bagaimana EMA akan beralih untuk menangani undang-undang baru?<\/strong><\/h2>\n<p class=\"\">\u201cPerjanjian mengenai undang-undang farmasi baru ini merupakan tonggak sejarah bagi regulasi obat-obatan di Eropa dan bagi pasien di seluruh UE, sebuah peluang emas untuk menjadi lebih tangkas dan efisien,\u201d kata Cooke dalam rilisnya (1).<\/p>\n<p class=\"\">Cooke mengatakan badan tersebut akan menggunakan kesempatan yang diberikan oleh undang-undang tersebut untuk memfokuskan upaya pada tiga bidang. Badan tersebut akan \u201cmembayangkan kembali\u201d cara kerjanya, dan Cooke berencana untuk mengadaptasi sistem agar dapat menangani kemajuan ilmu pengetahuan dan teknologi dengan lebih baik. Pengembangan dan inovasi awal akan didukung untuk memungkinkan otorisasi pasar yang lebih cepat. Investasi juga akan dilakukan pada staf dan jaringan tenaga kerja untuk membangun kapasitas dan kemampuan.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Rekomendasi obat apa yang dibuat oleh EMA?<\/strong><\/h2>\n<p class=\"\">EMA merekomendasikan 104 obat baru pada tahun 2025, 40% di antaranya merupakan zat aktif baru. Ini termasuk pengobatan pertama untuk menunda timbulnya diabetes tipe 1 stadium 3 pada orang dewasa dan anak-anak berusia delapan tahun ke atas. Pengobatan pertama untuk distrofi otot Duchenne juga direkomendasikan untuk pasien berusia enam tahun ke atas yang dapat berjalan. Eropa juga mendapatkan vaksin Chikungunya yang pertama untuk remaja berusia 12 tahun ke atas.<\/p>\n<p class=\"\">EMA juga merekomendasikan perubahan penggunaan antibiotik azitromisin untuk mengurangi kemungkinan resistensi antimikroba. Selain itu, tindakan direkomendasikan untuk meminimalkan risiko bunuh diri dengan finasteride dan dutasteride, yang digunakan untuk mengobati androgenetic alopecia pada pria.<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\"><strong>Bagaimana EMA berkolaborasi pada tahun 2025?<\/strong><\/h2>\n<p class=\"\">EMA meluncurkan <astro-island uid=\"Z3kUbn\" prefix=\"r60\" 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;1ac0e6780fb3&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;European Shortages Monitoring Platform&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;10c754d61d34&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/post-authorisation\/medicine-shortages-availability-issues\/european-shortages-monitoring-platform-esmp&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;10c754d61d34&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">Platform Pemantauan Kekurangan Eropa<!--astro:end--><\/astro-island>    pada bulan Januari untuk menyediakan sistem dan kerangka kerja yang terkoordinasi mengenai bagaimana badan tersebut bekerja dengan otoritas nasional dan pelaku di Uni Eropa untuk memastikan bahwa rantai pasokan obat-obatan kuat.<\/p>\n<p class=\"\">Badan tersebut berkoordinasi dengan Komisi Eropa dan badan pengatur lainnya untuk berkomunikasi di seluruh saluran dan bekerja dengan pembuat konten untuk mempromosikan penggunaan obat GLP-1 yang aman dan bertanggung jawab. \u201cDalam lingkungan di mana misinformasi menyebar lebih cepat daripada fakta, kita harus menerapkan pendekatan inovatif dalam komunikasi dan keterlibatan pemangku kepentingan,\u201d kata Cooke.<\/p>\n<p class=\"\">&#8220;Eropa selalu menjadi tempat di mana ide-ide memicu perubahan. Eropa memiliki ilmu pengetahuan dan keahlian kelas dunia. Kita perlu melindungi dan mempromosikan kekuatan-kekuatan ini,&#8221; lanjutnya. &#8220;Kita membutuhkan Eropa di mana fakta penting, inovasi berkembang, dan kolaborasi menang. Masa depan adalah milik kita untuk dibentuk\u2014mari kita bentuk bersama-sama, dengan ilmu pengetahuan.&#8221;<\/p>\n<h2 class=\"pb-4 pt-2 text-2xl\">Referensi<\/h2>\n<ol class=\"my-2\">\n<li class=\"ml-8 list-decimal\">EMA. Emer Cooke, Direktur Eksekutif EMA: Pencapaian 2025 dalam Regulasi Kedokteran. Siaran Pers. 19 Desember 2025. <astro-island uid=\"Z12UJGV\" prefix=\"r61\" 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;cd1c003ad278&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;https:\/\/www.ema.europa.eu\/en\/news\/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;4cf02ecaffcb&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.ema.europa.eu\/en\/news\/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;4cf02ecaffcb&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">https:\/\/www.ema.europa.eu\/en\/news\/emer-cooke-emas-executive-director-2025-achievements-medicine-regulation<!--astro:end--><\/astro-island><\/li>\n<li class=\"ml-8 list-decimal\">Parlemen Eropa. Kesepakatan tentang Reformasi Komprehensif Perundang-undangan Farmasi UE. Siaran Pers. 11 Desember 2025. <astro-island uid=\"Zmr6d5\" prefix=\"r62\" 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;2dd873f16c99&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;https:\/\/www.europarl.europa.eu\/news\/en\/press-room\/20251209IPR32110\/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;65cea2c8186a&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.europarl.europa.eu\/news\/en\/press-room\/20251209IPR32110\/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;65cea2c8186a&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">https:\/\/www.europarl.europa.eu\/news\/en\/press-room\/20251209IPR32110\/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation<!--astro:end--><\/astro-island><\/li>\n<li class=\"ml-8 list-decimal\">EMA. EMA Menyambut Baik Kesepakatan Politik mengenai Perundang-undangan Farmasi UE yang Baru. Siaran Pers. 11 Desember 2025. <astro-island uid=\"1qkQCx\" prefix=\"r63\" 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;ba4a94273918&quot;),&quot;children&quot;:(1,((0,{&quot;_type&quot;:(0,&quot;@text&quot;),&quot;text&quot;:(0,&quot;https:\/\/www.ema.europa.eu\/en\/news\/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation&quot;)}))),&quot;markDef&quot;:(0,{&quot;_key&quot;:(0,&quot;4c1bbeaa8eec&quot;),&quot;_type&quot;:(0,&quot;link&quot;),&quot;href&quot;:(0,&quot;https:\/\/www.ema.europa.eu\/en\/news\/ema-welcomes-political-agreement-new-eu-pharmaceutical-legislation&quot;)}),&quot;markType&quot;:(0,&quot;link&quot;),&quot;markKey&quot;:(0,&quot;4c1bbeaa8eec&quot;)})}\" ssr=\"\" client=\"load\" opts=\"{&quot;name&quot;:&quot;ExternalLinkPlugin&quot;,&quot;value&quot;:true}\" await-children=\"\">https:\/\/www.ema.europa.eu\/en\/news\/ema-welcomes-politik-agreement-new-eu-pharmaceutical-legislation<!--astro:end--><\/astro-island><\/li>\n<\/ol><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Pada 19 Desember 2025, Emer Cooke, direktur eksekutif Badan Obat Eropa (EMA), menerbitkan ringkasan pencapaian badan tersebut pada tahun 2025, yang menandai tiga dekade sejak didirikan. Di antara keberhasilan EMA adalah merekomendasikan 104 obat baru sepanjang tahun, dengan hampir 40% mengandung zat aktif baru (1). Peristiwa terbesar pada tahun 2025, menurut Cooke, adalah perjanjian antara [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":474,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-473","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>Direktur EMA Melihat Perubahan Perundang-undangan sebagai Puncak Tahun 2025 - Nova Anggreni, S.Farm, APT<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/\" \/>\n<meta property=\"og:locale\" content=\"id_ID\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Direktur EMA Melihat Perubahan Perundang-undangan sebagai Puncak Tahun 2025 - Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"og:description\" content=\"Pada 19 Desember 2025, Emer Cooke, direktur eksekutif Badan Obat Eropa (EMA), menerbitkan ringkasan pencapaian badan tersebut pada tahun 2025, yang menandai tiga dekade sejak didirikan. Di antara keberhasilan EMA adalah merekomendasikan 104 obat baru sepanjang tahun, dengan hampir 40% mengandung zat aktif baru (1). Peristiwa terbesar pada tahun 2025, menurut Cooke, adalah perjanjian antara [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/\" \/>\n<meta property=\"og:site_name\" content=\"Nova Anggreni, S.Farm, APT\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-19T19:47:55+00:00\" \/>\n<meta name=\"author\" content=\"pythonsonline\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Ditulis oleh\" \/>\n\t<meta name=\"twitter:data1\" content=\"pythonsonline\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimasi waktu membaca\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 menit\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/\"},\"author\":{\"name\":\"pythonsonline\",\"@id\":\"https:\/\/pythonsonline.com\/#\/schema\/person\/c1dd578cabc4e398492d9e25f7aff156\"},\"headline\":\"Direktur EMA Melihat Perubahan Perundang-undangan sebagai Puncak Tahun 2025\",\"datePublished\":\"2025-12-19T19:47:55+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/\"},\"wordCount\":504,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/pythonsonline.com\/#organization\"},\"image\":{\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/pythonsonline.com\/wp-content\/uploads\/2025\/12\/04bde34a65def76dbd22cdb5f9da9b2ca04f810b-1280x720.jpg\",\"articleSection\":[\"Blog\"],\"inLanguage\":\"id\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/\",\"url\":\"https:\/\/pythonsonline.com\/index.php\/2025\/12\/20\/direktur-ema-melihat-perubahan-perundang-undangan-sebagai-puncak-tahun-2025\/\",\"name\":\"Direktur EMA Melihat Perubahan Perundang-undangan sebagai Puncak Tahun 2025 - 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Di antara keberhasilan EMA adalah merekomendasikan 104 obat baru sepanjang tahun, dengan hampir 40% mengandung zat aktif baru (1). 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