Radiopharmaceutical regulation worldwide - The resemblances and the differences [Persian]

Document Type : Review Article


1 Department of Medicinal Chemistry, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

2 Research Institute for Nuclear Medicine, Tehran University of Medical Sciences, Tehran, Iran


A Radiopharmaceutical is a radioactive compound used for the diagnosis and treatment of human diseases. Radiopharmaceuticals are among the most highly regulated materials administered to patients because they are controlled both as drugs and as radioactive substances. The use of radiopharmaceuticals for any purpose is governed by regulatory agencies in different countries all over the world. Application of radiopharmaceuticals in humans was almost unregulated until the late 1950s. Since then a progression of regulations have been imposed on the use of these compounds in humans. The United states, United Kingdom, European community, Australia and New Zealand are among the pioneer countries in legislation of regulations concerning the preparation, distribution and use of radiopharmaceuticals. Several regulations, guidelines and reports have been published by federal or professional agencies involved in nuclear pharmacy and nuclear medicine to improve the quality of radiopharmaceutical services. While there are similarities in the backbone of the regulations and guidelines regarding radiopharmaceutical practice worldwide, the comprehensiveness of these regulations varies considerably from country to country and even among states of a country. In order to establish a set of radiopharmaceutical regulations for Iran, reviewing the previously published regulations and guidelines and access their conformity to domestic situations have valuable position and selected acts and topics based on local exigencies may serve as a guide for legislation of the regulations for importation, production and use of radiopharmaceuticals in Iran. The aim of this review is to summarize some of the important aspect of radiopharmaceutical regulations and principal agencies that have regulatory authority over the practice of radiopharmacy.


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