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

• Consultation period: 9 April to 9 June 2026 (60 calendar days)
• Submission platform: SICOPRE (online only – no email or paper submissions accepted)
• Requirements for comments: Each observation must include technical, scientific, or legal justification
• Access to draft: Available via the MEIC’s SICOPRE portal
• Legal basis for consultation: Article 70 of Executive Decree No. 44908-MEIC (21 January 2025), which regulates chapters I and II of the National Quality System Law

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

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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