The recent passage of a regulation allowing for the express registration of medications has raised concerns across various health sectors in Peru. Under the new rules, medications and biological products registered in countries with high health surveillance may be automatically approved if the DIGEMID does not respond within 45 days. While this measure aims tostreamline access to medical treatments, it could compromise quality and safety controls for products entering the country.

As noted in the statement, the regulation incorporates provisions from Bills No. 1422/2021-CR, 1880/2021-CR, 2273/2021-CR, and 4995/2022-CR, stipulating that if DIGEMID fails to evaluate an application within 45 days, the health registration will be granted automatically.

This automatic approval process has drawn criticism, as it may bypass the rigorous evaluations needed to ensure the efficacy and safety of medicines in the local context. Although the regulation seeks to improveaccess — particularly for treatments targeting rare diseases, orphan drugs, and certain cancers — experts warn that oversimplifying the process could endanger public health. 

Health organizations emphasize that the new rules do not differentiate between medication types, e.g.generics, biologicals, and biosimilars, each of which requires specific evaluations. Without thoroughtechnical reviews, substandard products could enter the market, undermining Peru’s health oversight.  

Additionally, the regulation does not mandate that medicines be manufactured in countries with stringent health surveillance, potentially enabling counterfeit or low-quality products. Pharmacologists caution that even medicines approved in elsewhere may vary in safety and efficacy due to differences in production sites.

This change in the drug registration process exposes DIGEMID’s operational limitations, including resource constraints, that hinder its ability to conduct timely, thorough evaluations. Despite ongoing efforts to strengthen the agency, deadlines and review mechanisms remain critical to safeguarding public health.

In response, health stakeholders urge a re-evaluation of the regulation to mitigate risks to patient safety and medication quality. Implementing these rules without robust technical oversight could compromise protections for Peruvian patients.

The debate continues, highlighting the need to balance expedited access with assurances of safety and efficacy.

Background
In 2011, the Peruvian health authorities established separate regulations for pharmaceutical drugs, i.e. chemically synthesised, and biotechnology drugs. In 2016, the Supreme Decree Number 013-2016-SA was released. This regulation is intended to give more specific requirements for biologicals and biosimilars, and to complement the general requirements covered in Supreme Decree Number 016-2011-SA [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Regulatory landscape for biosimilars in Latin America Latina[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-biosimilars-in-latin-america

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