Costa Rica opens consultation on biological medicines registration and control reform – Generics and Biosimilars Initiative

The Costa Rican Ministry of Health has initiated a 60-day public consultation period on proposed amendments to Executive Decree No. 37006-S of 15 November 2011 [1, 2], which establishes the regulatory framework for the registration and control of biological medicines under ‘RTRC 440: 2010’ (Reglamento de Inscripción y Control de Medicamentos Biológicos).
The announcement, published under notice MS-AJ-CB-801-2026, calls for a reform and addition to the existing decree. While the specific amendments are not detailed in the notice, interested parties are directed to review the full draft on the Prior Control System (SICOPRE) platform of the Ministry of Economy, Industry and Commerce (MEIC).
Key details for stakeholders
Why this matters
Biological medicines – including monoclonal antibodies, insulins, vaccines, and biosimilars – are subject to stricter regulatory oversight due to their complexity and immunogenicity risks. The proposed reform may affect registration requirements, post-marketing surveillance, traceability, pharmacovigilance standards, and biosimilar approval conditions.
For pharmaceutical companies operating in or exporting to Costa Rica, this consultation represents an opportunity to influence the regulatory environment before the decree is finalized. Healthcare professionals should be aware that changes to registration and control may affect product availability, prescribing protocols, and adverse event reporting requirements. 
Compliance note
Under Article 70 of Executive Decree No. 44908-MEIC, comments submitted outside the MEIC’s SICOPRE system will not be considered.
Next steps
Following the close of the consultation on 9 June 2026, the Ministry of Health will evaluate submissions before issuing a final decree. No enactment date has been announced.
Stakeholders are advised to review the full draft text promptly, as 60 days is a relatively short window for technical and legal analysis.
Related articles
Biosimilars approved in Costa Rica
The biosimilars market in Latin America: a summary
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References
1. GaBI Online – Generics and Biosimilars Initiative. Regulation of similar biotherapeutic products in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 24]. Available from: www.gabionline.net/biosimilars/research/Regulation-of-similar-biotherapeutic-products-in-Latin-America
2. GaBI Online – Generics and Biosimilars Initiative. Regulatory landscape for similar biotherapeutic products in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 24]. Available from: www.gabionline.net/biosimilars/research/regulatory-landscape-for-similar-biotherapeutic-products-in-latin-america
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