Mexico: Major change to the regulatory approval system for biosimilars, medicines and medical devices

In brief

On 31 May 2021, the Mexican President published on the Federal Official Gazette a major amendment to the Secondary Regulations for Health Supplies (Reglamento de Insumos para la Salud, “RIS”) (“Decree”). The Decree is effective as of 1 June 2021, affecting both medicines and medical devices. It improves the regulatory environment.


What it means for you?

Regulatory plans would need to revised, commercial intelligence about the biosimilar market would need to be reviewed and legal step plans for M&A transactions would be simplified. 

The Decree modifies significantly several aspects of the regulatory approval system for medicines and medical devices, which involves marketing authorizations (MAs). The amendment includes changes to the process: (i) to obtain MAs for biosimilars, (ii) to transfer all MAs, (iii) to renew all MAs, and (iv) to deplete inventory after any MA modification. However, it also  introduces new requirements for the labelling of medicines placed in the public health sector. 

The amendment mostly simplifies administrative processes, reduces the regulatory burden for both the regulator and the users and consequently reduces the costs for complying with the regulatory framework.

In more detail

The main changes introduced by the Decree include the following:

  • It implements the requirement to label products to be placed in the public sector, which had been incorporated previously to the General Health Law (Article 225). This increases costs and triggers suddenly the urgent need to revise the conditioning information in MAs. 
  • It accepts that supporting documents, submitted with applications, can now be filed in English, without an official translation to Spanish. This reduces the cost of submissions.
  • It eliminates the participation of the Subcommittee for the Evaluation of Biotech Products (SEBP) from the approval process of biosimilars. This simplifies the process and facilitates the introduction of biosimilars to Mexico, but also contradicts the General Health Law, which refers to the SEBP. 
  • It eliminates the step of defining a biocomparability test prior to authorizing indications, including its extrapolation. This will facilitate the introduction of biosimilars to Mexico. 
  • It eliminates the obligation to publish previously certain requirements, such as product specific immunogenicity studies or the set of requirements defined to approve the first biosimilar of a given molecule. This reduces transparency. 
  • It eliminates the obligation to conduct clinical trials in Mexico in order to obtain the first approval of a biosimilar, accepting data produced abroad, but requiring them at the first renewal of the MA. This will accelerate the introduction of biosimilars to Mexico. 
  • It introduces a reference that the process to modify MAs will be subject to a Technical Standard. To recall, there is an intention to issue a Draft Technical Standard for the Approval and Modification of MAs for (all) Medicines
  • It reiterates the rule applicable to the case where the authority does not respond within the legal deadline to applications of MA modifications (i.e., in case of administrative silence). It indicates that the respective application shall be deemed approved, which is known as an afirmativa ficta. This confirms a trend of this federal administration to rely confidently and more heavily on afirmativa fictas
  • It simplifies the system for granting a grace period for depleting inventory, giving directly the maximum of 240 business days (one year), instead of having an initial period of 120 days that required filing several extension requests.  This reduces the regulatory burden, simplifying the te administrative process. 
  • It transforms fundamentally the process to assign MAs, from requiring an approval of the MA (administrative) modification to requiring only a notification. This would generally unload and simplify the administrative process. Most importantly, it would represent a major improvement that would benefit and streamline the acquisition and divestiture of individual products, product portfolios and businesses in Mexico.  
  • For both medicines and medical devices, it transforms significantly the nature and the process to renew MAs. For the first renewals, it moves away from a full review to a more limited exercise. For the second and subsequent renewals, it migrates to a simple notification process. This simplifies the administrative process, reduces the costs of renewals and generally reduces the regulatory burden.
  • It eliminates multiple references to the Third Authorized Parties for the review of dossiers, signaling the disappearance of this useful but criticized stakeholder. This places a heavier responsibility on the regulator to comply with all legal deadlines and tackle alone the backlog of pending applications. 

For further information and to discuss the regulatory and wider implications of this important amendment, please get in touch with Baker McKenzie’s Healthcare & Life Sciences team.    


Contact Information
Christian López-Silva
Mexico City

Copyright © 2024 Baker & McKenzie. All rights reserved. Ownership: This documentation and content (Content) is a proprietary resource owned exclusively by Baker McKenzie (meaning Baker & McKenzie International and its member firms). The Content is protected under international copyright conventions. Use of this Content does not of itself create a contractual relationship, nor any attorney/client relationship, between Baker McKenzie and any person. Non-reliance and exclusion: All Content is for informational purposes only and may not reflect the most current legal and regulatory developments. All summaries of the laws, regulations and practice are subject to change. The Content is not offered as legal or professional advice for any specific matter. It is not intended to be a substitute for reference to (and compliance with) the detailed provisions of applicable laws, rules, regulations or forms. Legal advice should always be sought before taking any action or refraining from taking any action based on any Content. Baker McKenzie and the editors and the contributing authors do not guarantee the accuracy of the Content and expressly disclaim any and all liability to any person in respect of the consequences of anything done or permitted to be done or omitted to be done wholly or partly in reliance upon the whole or any part of the Content. The Content may contain links to external websites and external websites may link to the Content. Baker McKenzie is not responsible for the content or operation of any such external sites and disclaims all liability, howsoever occurring, in respect of the content or operation of any such external websites. Attorney Advertising: This Content may qualify as “Attorney Advertising” requiring notice in some jurisdictions. To the extent that this Content may qualify as Attorney Advertising, PRIOR RESULTS DO NOT GUARANTEE A SIMILAR OUTCOME. Reproduction: Reproduction of reasonable portions of the Content is permitted provided that (i) such reproductions are made available free of charge and for non-commercial purposes, (ii) such reproductions are properly attributed to Baker McKenzie, (iii) the portion of the Content being reproduced is not altered or made available in a manner that modifies the Content or presents the Content being reproduced in a false light and (iv) notice is made to the disclaimers included on the Content. The permission to re-copy does not allow for incorporation of any substantial portion of the Content in any work or publication, whether in hard copy, electronic or any other form or for commercial purposes.