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Hospital Pharmacology - International Multidisciplinary Journal
2015, vol. 2, br. 3, str. 322-327
jezik rada: engleski
vrsta rada: članak
doi:10.5937/hpimj1503322V
Regulativa kliničkih ispitivanja u Republici Srbiji
aMedicines and Medical Devices Agency of Serbia, Belgrade
bMedicines and Medical Devices Agency of Serbia - retired, Belgrade + Section for Clinical Pharmacology Serbian Medical Society, Belgrade

e-adresa: zorica.vucinic@alims.gov.rs

Sažetak

Uvod: Savremena kretanja u farmaciji, proizvodnji i prometu lekova kao primarni resurs stavljanja u promet kvalitetnih, efikasnih i bezbednih lekova imaju značajan zadatak da kroz klinička ispitivanja lekova obezbede bezbedne, efikasne i kvalitetne lekove. Tema: U radu se daje pregled uspostavljene aktuelne regulative u oblasti kliničkih ispitivanja lekova i ukazuje na značaj sprovođenja kliničkih ispitivanja. Metodologija: Na osnovu važećih propisa u Republici Srbiji i onih koji su uspostavljeni na nivou Evropske agencije (EMA) daje se prikaz ključnih elemenata koji su bitni za objektivne procedure koje se sprovode u kliničkim ispitivanjima lekova u Srbiji. Zaključak: Savremena farmakoterapija danas je izložena ozbiljnim izazovima obzirom na brojna istraživanja u oblasti medicine i farmacije koja se sprovode danas u svetu. Klinička ispitivanja su posebno osetljiv segment u ovoj oblasti koji zahteva od učesnika u tim procesima visoku edukovanost kao i ozbiljan etički pristup svim fazama ovih procesa.

Ključne reči

Reference

*** (2011) Rulebook on the contents of the application, and/or documentation on the approval of clinical trials for medicines and medical devices, as well as the method of implementation for clinical trials of medicines and medical devices. Official Gazette of the RS, The Rulebook hereof was published in the, nr. 64/2011 of 31 August 2011
*** (2011) Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines. Official Gazette of RS, No. 64, 31 August
*** Serbian legislation for clinical trials. available at http://www.alims.gov.rs/ciril/regulativa
*** (2010) Law on medicinal products and medical devices. Official Gazette of the Republic of Serbia, No. 30, 7th May
*** EU Anex-13: EU guidelines to good manufacturing practice for investigational medicinal products for human use. Volume 4
*** Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
*** Note for guidance on clinical investigation of medicinal products in the paediatric population. CPMP/ICH/2711/99
EC (2005) Commission directive 2005/28/EC of 8 April 2005. Official Journal of the European Union, L91/13-L91/19, 9. 4
European Medicines Agency (2002) ICH Topic E 6 (R1): Guideline for good clinical practice. CPMP/ ICH/135/95, July, GUIDANCE ON GOOD CLINICAL PRACTICE, CPMP/ICH/135/95
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