ANMAT has implemented regulatory reforms aimed at simplifying and accelerating drug approval procedures. These measures, formalized through Provision No. 3752/25 and published in the Official Gazette on 29 May 2025, seek to improve the availability of new therapeutic options on the market and facilitate free choice within the framework of authorized treatment indications.

According to current regulations, the Argentine regulatory process initially requires obtaining a drug's ‘Registration Certificate’. Once issued, the next step is the effective authorization for the commercialization of the first batch, a stage in which ANMAT verifies the technical and quality capabilities of the manufacturing facility.

Prior to this reform, this process included two evaluation stages of 45 business days each, which, combined with production times and potential requests for additional information, could delay market access by more than four months.

Under the new provision, each evaluation stage is reduced to 25 business days, and the required documentation has been reorganized, thus optimizing the process without compromising technical and quality controls. Furthermore, a ‘simplified procedure’ has been introduced for over-the-counter medications or products whose active ingredients have a well-established history of use, allowing the evaluation to focus solely on the product's manufacturing and quality.

These modifications are part of the administrative modernization plan promoted by the National Institute of Drugs (INAME/ANMAT), aimed at aligning procedures with international standards without compromising safety, efficacy, and quality requirements.

This trend has also been observed in other Latin American countries that have implemented specific frameworks for these products to improve their accessibility and technical regulation [1]. The Brazilian health regulatory agency (ANVISA) also previously adopted measures to strengthen its technical capacity and accelerate the approval of these products without relaxing regulatory requirements [2].

In summary, the reform driven by ANMAT represents a significant advancement in the efficiency of the Argentine regulatory system, aligning with a trend towards more agile and effective regulation.

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Regulatory landscape for similar biotherapeutic products in Latin America

References
1. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-biosimilars-in-latin-america
2. GaBI Online - Generics and Biosimilars Initiative. ANVISA's role in biosimilar medicine regulation and innovation promotion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Nov 13]. Available from: www.gabionline.net/biosimilars/research/anvisa-s-role-in-biosimilar-medicine-regulation-and-innovation-promotion

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