Webinar Recording
Central American Regulation for Drug Products (LATAM)
| On-Demand | 1 Hour | Your Desk! |
| On-Demand | 1 Hour | Your Desk! |
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Diego ZavalaRegional Senior Manager LATAM, PharmaLex |
In October 1993, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama signed the Protocol to the General Agreement of Central American Economic Integration, better known as Guatemala Protocol; such Protocol has as main objectives, among others, to reach an economic union, strengthening the finance system of the region and create a Central American Integration System supported in an Institutional and Legal Order.
This Central American System leads to the creation of the Council of Ministers of Economic Integration (COMIECO) composed by the Ministries of Economy of the country members, these Ministries were responsible to develop the Central American Technical Regulation (RTCA) that rule the Pharmaceutical Industry in the Region.
The RTCA is for the pharmaceutical industry covers several topics from the technical point of view like Analytical Method Validation, Good Manufacturing Practices, Labelling of Pharmaceutical Products, Quality Assurance, Stability Studies and Requirements for Marketing Authorizations. These regulations give clarity to the Pharmaceutical Companies regarding the expectations of the region for technical dossiers and help companies to accelerate their expansion projects in Central America.