ŠÚKL stanovil termín na predloženie pripomienok k usmerneniam týkajúcim sa klinického skúšania liekov | Medicínske právo
              

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ŠÚKL stanovil termín na predloženie pripomienok k usmerneniam týkajúcim sa klinického skúšania liekov


 | 29.6.2016 | komentárov: 328

ŠÚKL dňa 28.6.2016 informuje o možnosti vyjadriť sa k usmerneniam Európskej komisie, týkajúcich sa klinického skúšania liekov.

Obrazok

Oblasť klinického skúšania v súčasnosti upravuje Nariadenie Európskeho parlamentu a Rady Európskej únie č. 536/2014 o klinickom skúšaní liekov na humánne použitie, ktorým sa zrušuje smernica 2001/20/ES(ďalej len Nariadenie).Nariadenie predovšetkým chráni práva
a dôstojnosť účastníkov klinického skúšania liekov a zabezpečuje ich celkovú pohodu a bezpečnosť. Cieľom Nariadenia je zjednodušiť a harmonizovať správne ustanovenia, ktorými sa riadi klinické skúšanie v Únií a zabezpečiť tak postup, ktorý bude pružný a efektívny a to bez toho, aby sa ohrozila bezpečnosť pacientov alebo verejné zdravie. Veľmi dôležitú úlohu pri klinickom skúšaní zohrávajú členské štáty, ktoré by mali efektívne posúdiť všetky aplikácie klinického skúšania v rámci stanovených lehôt.
V rámci úloh zverených členským štátom sa ŠÚKL od roku 2014 snaží v čo najväčšej miere vyvíjať aktivity v rámci príprav na zásadné zmeny, ktoré Nariadenie prinesie. Medzi hlavné činnosti, ktoré ŠÚKL v tomto smere uskutočnil patrí príprava návrhov príslušných právnych
predpisov, ktoré boli predložené Ministerstvu zdravotníctva SR alebo upozorňovanie na rôzne problémy týkajúce oblasti klinického skúšania liekov. V tomto smere Európska komisia prijala niekoľko usmernení ktoré by mali pomôcť pri samotnej aplikácií Nariadenia.
Usmernenia sa týkajú  primeraných prístupov, súvisiacich s možnými rizikami, ktoré by mohli byť spojené s vykonávaním 
a plánovaním klinických skúšaní, primeraného spôsobu, ako vypracovať súhrn výsledkov klinického skúšania pre neodborníkov alebo napríklad  etických aspektov klinického skúšania s maloletými osobami. Komisia považuje za veľmi dôležité, aby zainteresované strany mali možnosť dôsledne preskúmať návrhy vyššie zmienených usmernení, a tak aktívne participovať na ich príprave. Preto dňa 1. júna 2016 oficiálne zahájila 3-mesačnú verejnú konzultáciu k uvedeným usmerneniam. ŠÚKL informuje, o tejto aktivite Komisie, aby sa do
verejnej konzultácie mala možnosť sa zapojiť široká odborná prípadne laická verejnosť aj v SR.

 



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