title: Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization.
abstract: BACKGROUND
  Clinical Trial Committee (CTC) has been established in Food and Drug Organization (FDO), in 2003 to assure efficacy and safety of all types of medicinal products which are meant to be registered in Iran Drug List and/or obtain market authorization.
  
  
  METHODS
  All clinical trial files, meeting minutes and databases in CTC secretariat in FDO were reviewed. Relevant information and data extracted, analyzed and reported.
  
  
  RESULTS
  Total number of clinical trial (CT) files received by CTC, in 2011, was 76 cases: 21 CT protocols, 45 CT reports and 10 requests for importation of investigational new medicinal products (IMPs). Number of CT files received for herbal and natural products was 8 cases while CT files reviewed for vaccines and biological products was 50; 66% of all CT files received. Local industries sponsored 28 CT studies while 47 studies were supported by multinational/foreign companies. Of all CT files reviewed, 54 cases accounted for phase III CTs and 20 cases for phase IV and periodic safety updated reports (PSUR). With respect to the decisions made by CTC in 2011, 23 out of 45 CT reports were approved and the number of clinical trial authorizations (CTA) issued were 11; 52% of all CT protocols reviewed.
  
  
  CONCLUSIONS
  Results presented in this report are indicative of a positive trend in compliance of pharmaceutical industries and clinical research groups to national regulations of CTs and IR-GCP. Effective communication with different parties involved in regulatory and industry sides of CTs will further enhance conducting quality CTs.
authors.affiliation: Office for Clinical Trials, Food and Drug Organization, Ministry of Health and Medical Education, Tehran, Iran ; Food and Drug Research Center, Food and Drug Organization, Ministry of Health and Medical Education, Tehran, Iran.
authors.forename: Seyed Ali Reza
authors.initials: SA
authors.lastname: Hosseini
authors.forename: Shadan
authors.initials: S
authors.lastname: Darbooy
authors.forename: Akram
authors.initials: A
authors.lastname: Salimi
keywords: Clinical Trial Committee; Clinical trials; Iran; Regulation; Report