The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has published Disposición 7998/2025, updating its Good Manufacturing Practices (GMP) certification process for foreign pharmaceutical manufacturing sites.
The new framework adopts Good Reliance Practices (GRP), aligned with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), allowing ANMAT to recognize GMP certificates and inspection reports issued by trusted regulatory authorities. The system is now risk-based, with differentiated requirements depending on the country of origin.
A new bilingual (Spanish–English) GMP certificate format with digital verification has also been introduced, replacing the previous procedure in force since 2005.
The measure strengthens regulatory convergence, reduces duplication of inspections, and facilitates faster market access to Argentina while maintaining high safety and quality standards.
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