Regulatory pathway of clinical trials in Iran

According to the WHO, the national regulatory authority should cover at least eight function in drug area including selection, registrations, licensing, clinical trials, inspections, distribution, marketing, and promotions. Monitoring clinical studies are one of the important regulatory requirement functions according to their interdisciplinary nature and research-implementation. In Iran, the Food and Drug Administration (NSA) acts as a national regulatory authority in the implementation of the monitoring of clinical trials and is committed to maintain close contact with ethics committees and the Iranian Registry of Clinical Trials. In fact, the structure of monitoring clinical trials is based on the three main committees Clinical Studies of the Food and Drug Organization, Ethics Committees for Medical Research, and Scientific Committee of the Center for Registering Trials. The Clinical Study Committee has been working at the Food and Drug Administration since recommendations from the World Health Organization (WHO) from 2003. We followed to identify the principles of the Good Clinical Practice (GCP) by the relevant ministry and simultaneously country s pharmaceutical division passed in the field of biotechnology knowledge as well as establishment of knowledge-based biotechnology products companies. The GCP is a set of international ethical and scientific qualifications that could cover all aspects of a clinical trial performed on a human. It assures design, development, process progression, documentation, and reporting phases and finally present results of the clinical study. Meanwhile, Iran s Clinical Trials Optimization Principles (IR GCP) has exploited and adapted the ICH / WHO GCP standards. We have a set of guidelines and rules which established based-on generally observed evidence and practical processes verified by laws, regulations and available procedures for the registration of medicines. In addition, IR GCP system possessed internationally designed and developed principles as well as has Iranian and applied features. In recent years, in line with technology innovation policy in Iran, significant progression has been made in the field of medical rehabilitation, with the formation of many knowledge-based companies. Furthermore, along with these innovative activities, the cell therapy and gene therapy is considered as an agenda of the food organization. In this program, standards and regulatory requirements for clinical trials will be highlighted, with emphasis on clinical trials.

کلیدواژه ها:

Clinical trials ، Drug organization ، Ethics committees ، Food and drug administration