Clinical trial Evaluation
Clinical trial is one of the fundamental steps in the marketing authorization of any product. The regulation of clinical trials aims to ensure the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible. In addition, the organization plays a key role in ensuring that the standards of good clinical practice (GCP) are applied.
The National Organization of Research and Control Of Biological Products relies on the results of preclinical and clinical trials carried out by pharmaceutical companies to reach its opinions on the authorization of medicines.
The regulatory oversight of clinical trials for biologicals is implemented by the Clinical Trials Evaluation department at NORCB on basis of presidential decrees no. (398/1995, 244/2009), ministerial decrees no. (95/2005, 436/2006, 297/2009, 399/2010, 150/2015, 820/2016), national and international guidelines ( ICH, WHO, and others…etc.).