Magister Pharmaceuticae - MPharm / In Central American countries (Guatemala, El Salvador, Honduras, Nicaragua,
Costa Rica and Panama) and Dominican Republic (DR) the approval timelines for major changes
are described ranging from 12 to 18 months, these timelines are considerably extensive. Other
countries or regions applying FDA post-approval change and EMA post-approval variation
guidelines have timelines of 6 months or less (Hoath et al, 2016, Murray, 2016). The research
aims to identify opportunities for alignment of the post-approval changes categories of Central
America (CA) and Dominican Republic (DR) National Regulatory Agencies (NRA) with the riskbased
categories of FDA and EMA as encouraged by the ICH. The FDA and EMA are considered
reference authorities for many countries, as they are Stringent Authorities.
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:uwc/oai:etd.uwc.ac.za:11394/8641 |
| Date | January 2021 |
| Creators | Vásquez, Ana Gabriela Trejos |
| Contributors | Upton, Edward |
| Publisher | University of Western Cape |
| Source Sets | South African National ETD Portal |
| Language | English |
| Detected Language | English |
| Rights | University of Western Cape |
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