Overview of the Regulatory Framework for Radiopharmaceuticals

Ahmeti Lika, Sihana and Alili Idrizi, Edita and Bexheti, Dorentina and Dauti, Merita and Janevik-Ivanovska, Emilija (2022) Overview of the Regulatory Framework for Radiopharmaceuticals. The Albanian Journal of Medical and Health Sciences, 59. pp. 1-11. ISSN 2413-3892

	Text 6. Edita Alili - Quality Audits - Viewpoints of Auditing in the Pharmaceutical Industry.pdf Download (205kB)
	Text 9-Ahmeti-et-al.pdf - Published Version Download (176kB)

Abstract

Radiopharmaceuticals are products that have the particularity of combining two very restrictive regulatory requirements depending on two different authorities: that of the drug in the pharmaceutical sense and that of a radioactive source linked to a specific authorization system. Radiopharmaceuticals are a new reality in the pharmaceutical industry and are considered to be an indicator of modern medicine and the technological industry. The exponential increase in their use is attributed to their dual use as diagnostic and therapeutic agents. They represent a group of pharmaceutical preparations, which contain radionuclides with short half-lives and are mainly administered intravenously. Maximum care should be taken during their
production, distribution, storage, and disposal because their radiant nature is a concern for both patients and medical staff. All stages of production must be done by the requirements of Good Manufacturing Practice. Therefore, radiopharmaceuticals must meet the requirements of the pharmaceutical regulator, the same as those of the nuclear regulator. The largest number of regulatory bodies in the world have different perspectives in terms of their production, distribution, transportation, storage, and disposal. However, in developed countries, the regulator of radiopharmaceuticals is in its infancy.
In this article, we will shed light on the various regulatorylimitationsimposedbythesestatutes, emphasizing that these regulations are therefore likely to evolve in the years to come and to demonstrate the importance of their development, proper use, and perspective.

Item Type:	Article
Subjects:	Medical and Health Sciences > Health sciences Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Emilija Janevik
Date Deposited:	04 Feb 2023 21:39
Last Modified:	04 Feb 2023 21:39
URI:	https://eprints.ugd.edu.mk/id/eprint/31312

Actions (login required)

View Item