Import Testing Requirements and Opportunities for Waivers

Duplicate full testing is performed in market of sale which delays availability of product to patients and creates a burden for companies that maintain appropriate quality sytems. Many countires in Latin America are adapting local regulations to meet quality expectations similar to those in highly regulated markets. Health authorities have been strengthening import testing requirements creating a complex regulatory environment for imported pharmaceuticals. This session will provide an overview on import testing regulations in the region, the requirements in major markets and will dicuss possible ways to waive duplicate testing. Participants will be informed of current regulations and requirements on import testing and opportunities to waive duplicate testing.