On February 5, 2026, Argentina and the United States signed the Reciprocal Trade and Investment Agreement between both countries (“ARTI”), which introduces relevant commitments in the areas of Life Sciences, market access, and intellectual property, with a direct impact on the pharmaceutical and medical devices industry.
With respect to medical devices, the ARTI provides that Argentina will accept as sufficient the prior approval or authorization issued by the U.S. Food and Drug Administration (FDA) to evidence compliance with local marketing authorization requirements for medical devices manufactured in the United States. Likewise, the Agreement establishes that marketing authorization will not be required for low‑risk medical devices where such authorization is not required by the FDA.
Additionally, Argentina commits to recognizing audits and quality management system certificates for medical device manufacturers conducted in accordance with the Medical Device Single Audit Program (MDSAP), without imposing additional regulatory requirements.
In the area of pharmaceuticals, the Agreement provides that Argentina will accept marketing authorizations granted by the FDA as sufficient evidence that pharmaceutical products manufactured in the United States comply with applicable local requirements. It further establishes that no re‑inspections or periodic reauthorizations will be required for such products, unless significant risks related to safety, quality, or efficacy are identified.
The ARTI also provides for the recognition of Good Manufacturing Practices (GMP) inspections conducted by the FDA at pharmaceutical manufacturing facilities located in the United States, without the need for additional inspections by the Argentine health authority, provided that the conditions set forth in the Agreement are met.
In the field of intellectual property, the ARTI includes commitments that could affect the Argentine pharmaceutical market, particularly by providing that Argentina submits the Patent Cooperation Treaty (PCT) for consideration by Congress, which would facilitate the filing of foreign patent applications.
In this context, there is a possibility that the patentability criteria currently in force in Argentina—which restrict certain developments commonly associated with the phenomenon known as evergreening—may be repealed or relaxed.
Should this scenario materialize, an increase in pharmaceutical patent filings could be expected, particularly with respect to second medical uses, new dosing regimens, pharmaceutical combinations, crystalline forms, salts, and alternative methods of manufacture or preparation.
The full text of the ARTI can be viewed here.
