Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization.
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.All clinical trial files, meeting minutes and databa...
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| Format: | Article |
| Language: | English |
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Tehran University of Medical Sciences
2013-01-01
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| Series: | Iranian Journal of Public Health |
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| Online Access: | https://ijph.tums.ac.ir/index.php/ijph/article/view/4756 |
| _version_ | 1818663332857511936 |
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| author | Seyed Ali Reza Hosseini Shadan Darbooy Akram Salimi |
| author_facet | Seyed Ali Reza Hosseini Shadan Darbooy Akram Salimi |
| author_sort | Seyed Ali Reza Hosseini |
| collection | DOAJ |
| description | 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.All clinical trial files, meeting minutes and databases in CTC secretariat in FDO were reviewed. Relevant information and data extracted, analyzed and reported.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.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. |
| first_indexed | 2024-12-17T05:15:10Z |
| format | Article |
| id | doaj.art-25b838221b244dc48d64c5b357e42880 |
| institution | Directory Open Access Journal |
| issn | 2251-6085 2251-6093 |
| language | English |
| last_indexed | 2024-12-17T05:15:10Z |
| publishDate | 2013-01-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Iranian Journal of Public Health |
| spelling | doaj.art-25b838221b244dc48d64c5b357e428802022-12-21T22:02:08ZengTehran University of Medical SciencesIranian Journal of Public Health2251-60852251-60932013-01-01421Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization.Seyed Ali Reza Hosseini0Shadan Darbooy1Akram Salimi2Office 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. 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.All clinical trial files, meeting minutes and databases in CTC secretariat in FDO were reviewed. Relevant information and data extracted, analyzed and reported.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.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.https://ijph.tums.ac.ir/index.php/ijph/article/view/4756Clinical Trial CommitteeClinical trialsIranRegulationReport |
| spellingShingle | Seyed Ali Reza Hosseini Shadan Darbooy Akram Salimi Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization. Iranian Journal of Public Health Clinical Trial Committee Clinical trials Iran Regulation Report |
| title | Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization. |
| title_full | Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization. |
| title_fullStr | Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization. |
| title_full_unstemmed | Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization. |
| title_short | Regulatory aspects of clinical trials in iran: third year report of clinical trial committee in food and drug organization. |
| title_sort | regulatory aspects of clinical trials in iran third year report of clinical trial committee in food and drug organization |
| topic | Clinical Trial Committee Clinical trials Iran Regulation Report |
| url | https://ijph.tums.ac.ir/index.php/ijph/article/view/4756 |
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