{"id":3871,"date":"2024-12-02T16:18:39","date_gmt":"2024-12-02T13:18:39","guid":{"rendered":"https:\/\/pharmaworlddergi.com\/?p=3871"},"modified":"2024-12-02T16:19:16","modified_gmt":"2024-12-02T13:19:16","slug":"turkiyede-ilac-ruhsatlandirma-sureci-ve-iyilestirilmesi-gereken-alanlar","status":"publish","type":"post","link":"https:\/\/pharmaworlddergi.com\/turkiyede-ilac-ruhsatlandirma-sureci-ve-iyilestirilmesi-gereken-alanlar\/","title":{"rendered":"T\u00fcrkiye\u2019de \u0130la\u00e7 Ruhsatland\u0131rma S\u00fcreci ve \u0130yile\u015ftirilmesi Gereken Alanlar"},"content":{"rendered":"\n

D\u00fcnyada ve T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcre\u00e7lerine ili\u015fkin sorular\u0131m\u0131z\u0131 yan\u0131tlayan \u0130E\u0130S Genel Sekreteri Sava\u015f Malko\u00e7, 2023 y\u0131l\u0131nda T\u00fcrkiye\u2019de T\u0130TCK taraf\u0131ndan sonu\u00e7land\u0131r\u0131lan ila\u00e7 ruhsat ba\u015fvurusu say\u0131s\u0131n\u0131n 421 oldu\u011funu ve bu hali ile 2011-2023 y\u0131llar\u0131 aras\u0131ndaki ortalama y\u0131ll\u0131k 640 ruhsat say\u0131s\u0131n\u0131n olduk\u00e7a alt\u0131nda kald\u0131\u011f\u0131n\u0131 belirtti. Malko\u00e7, 2024 y\u0131l\u0131n\u0131n ilk 8 ay\u0131nda \u00e7\u0131kart\u0131lan ruhsat say\u0131s\u0131n\u0131n 270 adet ile s\u0131n\u0131rl\u0131 kald\u0131\u011f\u0131n\u0131 ifade etti.<\/strong><\/p>\n\n\n\n

T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcre\u00e7leri nas\u0131l i\u015fliyor, D\u00fcnyadaki di\u011fer \u00fclkelerde durum nas\u0131l, bizdeki i\u015fleyi\u015f ile farklar var m\u0131?<\/strong><\/p>\n\n\n

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Bilindi\u011fi \u00fczere, T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcre\u00e7leri, Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131m\u0131za ba\u011fl\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu (T\u0130TCK) taraf\u0131ndan y\u00fcr\u00fct\u00fcl\u00fcyor.<\/p>\n\n\n\n

\u00dclkemizde ila\u00e7lar\u0131n ruhsatland\u0131rma i\u015flemleri, 1262 say\u0131l\u0131 \u0130spen\u00e7iyari ve T\u0131bbi M\u00fcstahzarlar Kanunu ve Avrupa Birli\u011fi mevzuat\u0131na uyum \u00e7al\u0131\u015fmalar\u0131 \u00e7er\u00e7evesinde haz\u0131rlanan, 2005 y\u0131l\u0131 ba\u015f\u0131nda y\u00fcr\u00fcrl\u00fc\u011fe giren ve 2013 y\u0131l\u0131nda g\u00fcncellenen Be\u015feri T\u0131bbi \u00dcr\u00fcnler Ruhsatland\u0131rma Y\u00f6netmeli\u011fi h\u00fck\u00fcmlerine g\u00f6re yap\u0131lmaktad\u0131r. Ba\u015fvuru dosyalar\u0131 uluslararas\u0131 bir dosya bi\u00e7imi olan ve 5 mod\u00fclden olu\u015fan CTD (Common Technical Document) bi\u00e7imindedir. CTD; Avrupa, ABD ve Japonya\u2019daki ila\u00e7 ruhsatland\u0131rma makamlar\u0131na yap\u0131lacak ba\u015fvurular\u0131n planl\u0131 bir \u015fekilde sunulmas\u0131n\u0131 hedefleyen ve uluslararas\u0131 alanda \u00fczerinde uzla\u015fmaya var\u0131lan bir formatt\u0131r.<\/p>\n\n\n\n

Bu format \u00e7er\u00e7evesinde ila\u00e7 firmalar\u0131m\u0131z taraf\u0131ndan eksiksiz yap\u0131lan ba\u015fvurunun, kabul edilmesini takiben sonu\u00e7land\u0131r\u0131lmas\u0131 Avrupa Birli\u011fi\u2019nde oldu\u011fu gibi bizde de mevzuat\u0131m\u0131zda 210 g\u00fcn ile s\u0131n\u0131rland\u0131r\u0131lm\u0131\u015ft\u0131r. T\u0130TCK\u2019n\u0131n \u00fcr\u00fcnlerin; kalite, etkililik ve g\u00fcvenlik verileri do\u011frultusunda bilimsel a\u00e7\u0131dan de\u011ferlendirmesi sonras\u0131 ruhsat verilir.<\/p>\n\n\n\n

Avrupa Birli\u011fi\u2019nde ila\u00e7 firmalar\u0131 do\u011frudan Avrupa \u0130la\u00e7 Ajans\u0131\u2019na (EMA) ba\u015fvurarak merkezi prosed\u00fcr\u00fc ba\u015flatabilir. Bu prosed\u00fcrle ruhsatland\u0131r\u0131lan \u00fcr\u00fcnler, AB\u2019nin t\u00fcm \u00fcye \u00fclkelerinde ge\u00e7erli olacak \u015fekilde piyasaya sunulur. Ancak, bu konuda esas otorite AB Komisyonu olup EMA\u2019n\u0131n tavsiyeleri do\u011frultusunda nihai karar\u0131 vermektedir.<\/p>\n\n\n\n

\u00d6te yandan, AB\u2019de her \u00fcye \u00fclkenin ayr\u0131 ulusal ruhsatland\u0131rma otoriteleri de bulunmaktad\u0131r. Bu itibarla, mevcut bulunan ulusal bir ruhsat\u0131n kar\u015f\u0131l\u0131kl\u0131 tan\u0131ma yoluyla di\u011fer \u00fcye \u00fclkelerde de tan\u0131nmas\u0131 ya da hi\u00e7bir ruhsat yoksa ayn\u0131 ruhsat ba\u015fvurusunun birden fazla \u00fcye devlette yap\u0131ld\u0131\u011f\u0131 merkezi olmayan prosed\u00fcre ba\u015fvurulmas\u0131 m\u00fcmk\u00fcnd\u00fcr.<\/p>\n\n\n\n

ABD\u2019de ise, ruhsatland\u0131rma konusunda tek yetkili merkezi kurulu\u015f Amerikan G\u0131da ve \u0130la\u00e7 \u0130daresi\u2019dir (FDA).<\/p>\n\n\n\n

2023 y\u0131l\u0131nda ne kadar ila\u00e7 ruhsat ald\u0131, \u00f6nceki y\u0131llarda bu rakamlar nas\u0131ld\u0131? Ge\u00e7mi\u015f y\u0131llara g\u00f6re say\u0131lar\u0131n azald\u0131\u011f\u0131n\u0131 biliyoruz, nedenleri neler?<\/strong><\/p>\n\n\n\n

Ruhsatland\u0131rma s\u00fcre\u00e7lerinin mevzuatta belirtilen s\u00fcrelerde sonu\u00e7land\u0131r\u0131lmas\u0131 sekt\u00f6r\u00fcm\u00fcz\u00fcn ve T\u0130TCK\u2019n\u0131n \u00f6ncelikli konular\u0131ndand\u0131r. Bununla birlikte, \u00f6zellikle 2024 y\u0131l\u0131nda ruhsat s\u00fcre\u00e7lerinde yava\u015flama oldu\u011fu g\u00f6r\u00fclmektedir. Mevzuatta 210 g\u00fcnle s\u0131n\u0131rland\u0131r\u0131lan ruhsatland\u0131rma s\u00fcre\u00e7leri fiiliyatta \u00e7ok daha uzun s\u00fcreler alabilmektedir.<\/p>\n\n\n\n

2023 y\u0131l\u0131nda T\u00fcrkiye\u2019de T\u0130TCK taraf\u0131ndan sonu\u00e7land\u0131r\u0131lan ila\u00e7 ruhsat ba\u015fvurusu say\u0131s\u0131 421 olmu\u015ftur. Bu, 2011-2023 y\u0131llar\u0131 aras\u0131ndaki ortalama y\u0131ll\u0131k 640 ruhsat say\u0131s\u0131n\u0131n olduk\u00e7a alt\u0131nda kalmaktad\u0131r. 2024 y\u0131l\u0131n\u0131n ilk 8 ay\u0131nda ise elimizdeki veriye g\u00f6re \u00e7\u0131kart\u0131lan ruhsat say\u0131s\u0131 270 adet ile s\u0131n\u0131rl\u0131 kalm\u0131\u015ft\u0131r.  <\/p>\n\n\n\n

2000 y\u0131l\u0131 ba\u015f\u0131ndan bu yana devam eden sorunlarda; komisyonlarla ilgili ya\u015fanan ciddi ve kritik sorunlar, personel say\u0131s\u0131ndaki yetersizlikler, kurumun uluslararas\u0131 otoritelere uyum sa\u011flamak amac\u0131yla mevzuat ve uygulamalar\u0131n\u0131 g\u00fcncelliyor olmas\u0131n\u0131n ilk a\u015famalarda ilave y\u00fckler getiriyor olmas\u0131 etkili olmu\u015ftur. Ayr\u0131ca, E-CTD uygulamas\u0131nda ya\u015fanan sorunlar da s\u00fcre\u00e7lerin uzamas\u0131na yol a\u00e7maktad\u0131r.<\/p>\n\n\n\n

Ruhsatland\u0131rma konusunda son y\u0131llarda ya\u015fanan en \u00f6nemli zorluk ve sorunlar\u0131 neler olu\u015fturuyor?<\/strong><\/p>\n\n\n

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Sekt\u00f6r\u00fcm\u00fcz\u00fcn en \u00f6ncelikli ve kritik konusu; ruhsatland\u0131rma s\u00fcre\u00e7lerinde ya\u015fanan s\u0131k\u0131nt\u0131lar ve gecikmelerdir. Bunun yan\u0131 s\u0131ra varyasyon de\u011ferlendirme s\u00fcre\u00e7lerinin \u00e7ok uzun olmas\u0131, firmalar taraf\u0131ndan yap\u0131lmas\u0131 planlanan de\u011fi\u015fikliklerin uygulamaya al\u0131nmas\u0131nda aksamalara neden olmaktad\u0131r. Acil varyasyon kapsam\u0131na al\u0131nma durumu sadece “tedarik sorunu ya\u015fanan \u00fcr\u00fcnler” olarak g\u00f6z \u00f6n\u00fcne al\u0131nd\u0131\u011f\u0131ndan aciliyeti olan di\u011fer ba\u015fvurular \u00f6nceliklendirilememektedir. Bu kapsam\u0131n geni\u015fletilmesi b\u00fcy\u00fck \u00f6nem ta\u015f\u0131maktad\u0131r.<\/p>\n\n\n\n

Uygulamaya ge\u00e7i\u015f i\u00e7in onay gerektiren Tip IB ve Tip II ba\u015fvurular\u0131n\u0131n \u00f6n de\u011ferlendirme s\u00fcrelerinin \u00f6ng\u00f6r\u00fclememesi sebebiyle olu\u015fan maddi kay\u0131plar \u00e7ok b\u00fcy\u00fck olmaktad\u0131r. Di\u011fer bir zorluk ise AB\u2019de \u00e7oklu doz ruhsat ba\u015fvurular\u0131nda tek dosya ile ilerlenebilmekte iken T\u00fcrkiye\u2019de halen her bir doz i\u00e7in ayr\u0131 ruhsat ba\u015fvuru dosyas\u0131 sunulmas\u0131n\u0131n talep edilmesidir.<\/p>\n\n\n\n

En \u00f6nemli sorunlardan biri de T\u0130TCK ile ileti\u015fimin h\u0131zl\u0131 ilerleyememesidir. Randevu konusunda bir iyile\u015ftirme yap\u0131lmas\u0131 sekt\u00f6rdeki firmalar\u0131n yat\u0131r\u0131mlar\u0131n\u0131 daha h\u0131zl\u0131 \u015fekilde yapmalar\u0131n\u0131 sa\u011flayacakt\u0131r.<\/p>\n\n\n\n

Ruhsat s\u00fcre\u00e7lerini k\u0131saltmak ve prosed\u00fcr\u00fc azaltmak ad\u0131na neler yap\u0131labilir, bu konuda \u0130E\u0130S olarak \u00f6nerileriniz neler olabilir?<\/strong><\/p>\n\n\n

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Son d\u00f6nemde T\u0130TCK taraf\u0131ndan uluslararas\u0131 normlara uygun \u00e7\u0131kart\u0131lan d\u00fczenlemelerin yerinde oldu\u011funu d\u00fc\u015f\u00fcnmekle birlikte, uyum s\u00fcre\u00e7lerinin ruhsat s\u00fcre\u00e7lerini uzatmas\u0131ndan da endi\u015fe duymaktay\u0131z. Uyum \u00e7al\u0131\u015fmalar\u0131n\u0131n T\u0130TCK\u2019n\u0131n kurumsal yap\u0131s\u0131n\u0131n g\u00fc\u00e7lendirilmesi sonras\u0131nda ve a\u015fama a\u015fama hayata ge\u00e7irilmesinin yerinde olaca\u011f\u0131n\u0131 de\u011ferlendiriyoruz. \u00d6zellikle, ruhsatland\u0131rma s\u00fcre\u00e7lerinde talep edilen analizlerin, t\u00fcm d\u00fcnyada oldu\u011fu gibi, ila\u00e7 piyasaya sunulduktan sonra piyasa kontrolleri yoluyla yap\u0131lacak olmas\u0131n\u0131 \u00e7ok de\u011ferli buluyoruz. Bu yasal d\u00fczenlemeye dair alt mevzuat\u0131n bir an evvel y\u00fcr\u00fcrl\u00fc\u011fe girmesini bekliyoruz.<\/p>\n\n\n\n

Do\u011fal olarak yap\u0131lan her d\u00fczenleme, Kurum\u2019a ilave y\u00fck getirmekte, bu ise ruhsat s\u00fcre\u00e7lerin uzamas\u0131na yol a\u00e7maktad\u0131r. Bunun a\u015f\u0131lmas\u0131 i\u00e7in T\u0130TCK\u2019n\u0131n nitelikli personel say\u0131s\u0131n\u0131n art\u0131r\u0131lmas\u0131n\u0131n ve sonras\u0131nda mevcut kurumsal yap\u0131da da baz\u0131 yeni d\u00fczenlemeler yap\u0131lmas\u0131 elzem g\u00f6r\u00fcyoruz. <\/p>\n","protected":false},"excerpt":{"rendered":"

D\u00fcnyada ve T\u00fcrkiye\u2019de ila\u00e7 ruhsatland\u0131rma s\u00fcre\u00e7lerine ili\u015fkin sorular\u0131m\u0131z\u0131 yan\u0131tlayan \u0130E\u0130S Genel Sekreteri Sava\u015f Malko\u00e7, 2023 y\u0131l\u0131nda T\u00fcrkiye\u2019de T\u0130TCK taraf\u0131ndan sonu\u00e7land\u0131r\u0131lan ila\u00e7 ruhsat ba\u015fvurusu say\u0131s\u0131n\u0131n 421 oldu\u011funu ve bu hali ile 2011-2023 y\u0131llar\u0131 aras\u0131ndaki ortalama y\u0131ll\u0131k 640 ruhsat say\u0131s\u0131n\u0131n olduk\u00e7a alt\u0131nda kald\u0131\u011f\u0131n\u0131 belirtti. Malko\u00e7, 2024 y\u0131l\u0131n\u0131n ilk 8 ay\u0131nda \u00e7\u0131kart\u0131lan ruhsat say\u0131s\u0131n\u0131n 270 adet ile s\u0131n\u0131rl\u0131 kald\u0131\u011f\u0131n\u0131 ifade etti.<\/p>\n","protected":false},"author":1,"featured_media":3876,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[48,2],"tags":[],"_links":{"self":[{"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/posts\/3871"}],"collection":[{"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/comments?post=3871"}],"version-history":[{"count":2,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/posts\/3871\/revisions"}],"predecessor-version":[{"id":3878,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/posts\/3871\/revisions\/3878"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/media\/3876"}],"wp:attachment":[{"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/media?parent=3871"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/categories?post=3871"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmaworlddergi.com\/wp-json\/wp\/v2\/tags?post=3871"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}