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University of the Western Cape
The impact an accredited third party assessor will have on the regulator’s response time
Abstract
dc:description.abstractGlobally regulators have been under scrutiny for delays in market application (MA) approvals. The main issue that surfaces in studies related to these delays is a shortage in competent reviewers. The concept of a third party assessor (TPA) who performs pre-market approvals is introduced, one who will be providing assistance to the national medicine regulatory authority (NMRA), therefore functioning on the principle of public private partnerships (PPPs). The aim of this professional body would be to decrease dossier review time, increasing the availability to medicine, medicine-related products and medical devices that comply with quality, safety and efficacy standards to treatment programs in a shorter time
Degree
thesis:*- Grantor dc:publisher.institution
- University of the Western Cape
- Year dc:date.issued
- 2014
Author and committee
dc:creator, dc:contributor.*- Author dc:creator
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- Dreyer, Nadia