ANMAT Streamlines Oversight of Foreign Drug Manufacturers with New GMP Certification Framework

Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) has unveiled a sweeping update to its regulatory framework for imported medicines through Disposición 7998/2025, which establishes new procedures for certifying Good Manufacturing Practices (GMP) at foreign pharmaceutical plants.

The reform,accompanied by two detailed annexes, introduces a modern system that speeds up certification while maintaining the highest standards of safety, quality, and transparency for medicines entering the Argentine market.

Harnessing Global Trust: Reliance and Risk-Based Evaluation

The new regulation allows ANMAT to apply Good Reliance Practices (GRP), a model promoted by the World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S), to recognize inspection results and certifications issued by trusted foreign regulatory authorities.

This means that, depending on the country of origin and the inspecting authority, ANMAT can rely on verified GMP documentation rather than repeating inspections unnecessarily, reducing duplication and facilitating faster market access for compliant medicines. According to Annex I, titled “Guidelines for the Processing of GMP Certificates for Manufacturing Plants Located Abroad,” ANMAT will evaluate certification requests under a tiered, risk-based system:

• PIC/S Member Countries: Applications can include existing GMP certificates and inspection details.
• Authorities Recognized by PAHO/WHO: Plants inspected by national regulators rated Level III or IV by the Pan American Health Organization can apply using similar documentation, plus a Site Master File (SMF).
• MERCOSUR Members: Manufacturers within the regional trade bloc must provide certificates, inspection records, SMFs, and inspection histories.
• Other Countries: Facilities outside these frameworks will undergo direct verification or inspection by ANMAT before approval.

The Instituto Nacional de Medicamentos (INAME) will have 40 business days to review initial submissions and may require additional virtual or on-site inspections. Each certificate’s validity will depend on the risk analysis conducted, and companies must request recertification up to 60 business days before expiry.

New Standardized GMP Certificate

The newly approved Annex II presents a bilingual (Spanish–English) certificate format that will serve as the official proof of compliance. It details the manufacturer’s name and address, the inspecting authority, the manufacturing processes covered, and the date of inspection. Each certificate includes a verification link to ANMAT’s official platform, Visor GEDO, enabling transparent public validation of authenticity.

A Modernized, Cooperative Regulatory Model

By adopting this updated certification system, ANMAT joins leading international regulators in emphasizing collaboration and mutual recognition of inspections. The model supports global supply chain resilience, reduces inspection backlogs, and ensures that Argentina’s oversight remains rigorous yet adaptable to modern pharmaceutical realities. The new measure repeals Disposición ANMAT 2123/2005, replacing a 20-year-old procedure with one grounded in regulatory convergence, digital verification, and science-based decision-making.

Implications for Industry

Pharmaceutical companies exporting to Argentina will now benefit from clearer, harmonized certification criteria, faster evaluations for recognized authorities, and a more predictable renewal process. For further details, you can consult the Disposicion here (in Spanish)