{"id":11500,"date":"2026-04-24T13:19:29","date_gmt":"2026-04-24T13:19:29","guid":{"rendered":"https:\/\/globalnewstoday.uk\/index.php\/2026\/04\/24\/costa-rica-opens-consultation-on-biological-medicines-registration-and-control-reform-generics-and-biosimilars-initiative\/"},"modified":"2026-04-24T13:19:29","modified_gmt":"2026-04-24T13:19:29","slug":"costa-rica-opens-consultation-on-biological-medicines-registration-and-control-reform-generics-and-biosimilars-initiative","status":"publish","type":"post","link":"https:\/\/globalnewstoday.uk\/index.php\/2026\/04\/24\/costa-rica-opens-consultation-on-biological-medicines-registration-and-control-reform-generics-and-biosimilars-initiative\/","title":{"rendered":"Costa Rica opens consultation on biological medicines registration and control reform – Generics and Biosimilars Initiative"},"content":{"rendered":"

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 \u2018RTRC 440: 2010\u2019 (<\/i>Reglamento de Inscripci\u00f3n y Control de Medicamentos Biol\u00f3gicos<\/i>).<\/i>
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<\/b>
Why this matters<\/b>
Biological medicines \u2013 including monoclonal antibodies, insulins, vaccines, and biosimilars \u2013 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. <\/i>
Compliance note<\/b>
Under Article 70 of Executive Decree No. 44908-MEIC, comments submitted outside the MEIC’s SICOPRE system will not be considered.
Next steps<\/b>
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<\/b>
Biosimilars approved in Costa Rica<\/a>
The biosimilars market in Latin America: a summary<\/a>
LATIN AMERICAN FORUM<\/b>
The objective of GaBI\u2019s 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 m\u00e1s seguras y r\u00e1pidas<\/a>
Browse<\/a> the news in the Latin American Forum!
Register<\/a> to receive the GaBI Latin American Forum newsletter. Inform<\/a> colleagues and friends of this new initiative.
FORO LATINOAMERICANO<\/b>
El objetivo del Foro Latinoamericano de GaBI es brindarle las \u00faltimas noticias y actualizaciones sobre desarrollos de medicamentos gen\u00e9ricos y biosimilares en Am\u00e9rica Latina en espa\u00f1ol.
Ver el \u00faltimo art\u00edculo de cabecera: La jeringa precargada del biosimilar de aflibercept (AVT06) promete inyecciones oculares m\u00e1s seguras y r\u00e1pidas<\/a>
!Explore<\/a> las noticias en el Foro Latinoamericano!
Reg\u00edstrese<\/a> para recibir el bolet\u00edn informativo GaBI Foro Latinoamericano. Informe<\/a> a colegas y amigos sobre esta nueva iniciativa. 
 
References<\/b>
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<\/a>
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<\/a>
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any \u2018Content\u2019 found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher<\/a> <\/i>to obtain permission before redistributing.<\/i>
Copyright \u2013 Unless otherwise stated all contents of this website are \u00a9 2026 Pro Pharma Communications International. All Rights Reserved.<\/i>
FDA Monoclonal Antibody Testing Guidance faces industry scrutiny<\/a>
EMA adopts landmark reflection paper on tailored clinical approach for biosimilars<\/a>
Trastuzumab in Peru: current situation and prospects<\/a>
China now accounts for 20% of global drug development<\/a>
About GaBI<\/a>
The best selling biotechnology drugs of 2008: the next biosimilars targets<\/a>
Global biosimilars guideline development \u2013 EGA\u2019s perspective<\/a>
EU guidelines for biosimilars<\/a>
China updates regulations to encourage research and innovation and improved drug safety<\/a>
Brazil and Mexico forge alliance to streamline medical approvals and boost production<\/a>
EU accepts results from FDA GMP inspections for sites outside the US <\/a>
WHO to remove animal tests and establish 17 reference standards for biologicals<\/a>
Sign up today for the weekly briefing on the latest developments in generic and biosimilar medicines!
Building trust in cost-effective treatments
\u00a9 2026 Generics and Biosimilars Initiative (GaBI) All Rights Reserved Designed by Zwebb<\/a>. Powered by IBEXA\u2122<\/span>
Our website uses cookies to improve your user experience. By continuing to browse the site you consent to use of cookies.<\/p>\n

source<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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 \u2018RTRC 440: 2010\u2019 (Reglamento de Inscripci\u00f3n y Control de Medicamentos Biol\u00f3gicos).The announcement, published under notice MS-AJ-CB-801-2026, calls […]<\/p>\n","protected":false},"author":1,"featured_media":11501,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":{"0":"post-11500","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-politics"},"_links":{"self":[{"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/posts\/11500","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/comments?post=11500"}],"version-history":[{"count":0,"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/posts\/11500\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/media\/11501"}],"wp:attachment":[{"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/media?parent=11500"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/categories?post=11500"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/globalnewstoday.uk\/index.php\/wp-json\/wp\/v2\/tags?post=11500"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}