##  [COFEPRIS Publishes Technical Guide for the Recognition of Orphan Medicines (CTD-based)](/index%2ephp/mandate/cofepris-publishes-technical-guide-for-the-recognition-of-orphan-medicines-ctd-based) 

October 17, 2025

The guide defines a prevalence threshold of ≤ 5 individuals per 10,000 inhabitants and details the structure of Modules 1–5, including requirements for pharmacovigilance, stability, labeling, and manufacturing certification.

This initiative aims to align Mexico’s regulatory framework with international best practices and to facilitate access to treatments for rare diseases.



[Consult Now](/webform/consult?url=https://preprod.freyrsolutions.com/index%2ephp/mandate/cofepris-publishes-technical-guide-for-the-recognition-of-orphan-medicines-ctd-based)



Source

[https://www.gob.mx/cofepris/documentos/documento-tecnico-comun-ctd-para-reconoc…](https://www.gob.mx/cofepris/documentos/documento-tecnico-comun-ctd-para-reconocimiento-de-medicamentos-huerfanos?state=published&utm_source=chatgpt.com)

 

 

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[Country Regulatory Affairs](/index%2ephp/mandate-by-function/country-regulatory-affairs)