Costa Rica opens consultation on biological medicines registration and control reform

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Costa Rica opens consultation on biological medicines registration and control reform

Home/Policies & Legislation | Posted 24/04/2026 0 Post your comment

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

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

LATIN AMERICAN FORUM
The objective of GaBI’s Latin American Forum is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: La jeringa precargada del biosimilar de aflibercept (AVT06) promete inyecciones oculares más seguras y rápidas

Browse the news in the Latin American Forum!

FORO LATINOAMERICANO
El objetivo del Foro Latinoamericano de GaBI es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: La jeringa precargada del biosimilar de aflibercept (AVT06) promete inyecciones oculares más seguras y rápidas

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.