A qualitative evaluation on the appropriateness of the current regulatory guidelines, on the manufacture of medicines within the radiopharmaceutical industry

Abstract

The purpose of this research thesis, is to evaluate the appropriateness of the current regulatory guidelines on the manufacture of medicinal products within the radiopharmaceutical industry. The manufacture of radiopharmaceuticals is governed by two main regulatory bodies. The regulatory authority responsible for the governance of the pharmaceutical product has the primary objective of ensuring the safety, efficacy and purity of the products manufactured, while the nuclear regulator has the responsibility of ensuring that the products used and manufactured are done so in a safe and responsible manner. The main problem faced by this industry is one where the requirements between the two regulators are, in some instances, in direct conflict of each other. The methodology employed in this study included the review of current regulatory guidelines applicable to the manufacture of orthodox pharmaceuticals, compared to its applicability to the radiopharmaceutical industry. This review showed that the regulatory guidelines, when adopted without industry specific concessions, resulted in an industry which is not as appropriately regulated as orthodox medicines are. It is therefore concluded that, in order for the radiopharmaceutical manufacturing industry to be as appropriately regulated as the orthodox pharmaceutical industry, industry-specific guidelines are required to be developed by the regulatory authorities and adopted by the manufacturing industry.