Regulatory Control of Radiopharmaceuticals in Tanzania

摘要

Millions of nuclear medicine procedures are performed each year worldwide and the demandrnfor radioisotopes is increasing rapidly. The use of radiopharmaceuticals in Tanzania like in many otherrncountries has been increasing in recent years that necessitate the need for close regulatory control. Theirrnapplications in the country started in 1980`s in the areas of medical diagnosis and therapy and at presentrnone center provides such services. The regulatory framework for nuclear safety, radiation protection andrnsecurity of radioactive materials was established following the national interest in the area of peacefulrnapplications of nuclear technology. The regulations require that any person intending to import, export orrntransport any apparatus, article, plant, installation or other material or substance which is a source orrnintended to be used for the purposes of an undertaking involving the emission of radiation, must apply forrna license from the regulatory authority. Radiopharmaceuticals are not produced in the country thereforernwhoever intends to import, possess and use has to obtain an authorization from the regulatory authority.rnThis paper describes how radiopharmaceuticals are regulated from importation, their use and thernmanagement of the resulting radioactive wastes. It explains the strengths and weakness of the existing Actrnand regulations governing the authorization of peaceful nuclear applications in the country. At presentrnnearly all aspects of peaceful applications of nuclear technology, including the use ofrnradiopharmaceuticals are being regulated satisfactorily. However, the following drawbacks in thernregulatory process have been identified; inadequate number of qualified nuclear medicine personnel, lackrnof periodical calibration of dose calibrators, one year validity of license to import radiopharmaceuticalsrnmay give the licensee a room for multiple importations of radiopharmaceuticals without verification byrnthe regulatory authority. Providing adequate training to nuclear medicine personnel and providingrnadequate resources to the regulatory authority can overcome most of the difficulties encountered.