A new decree modifies several aspects of the regulatory approval system for biosimilars in Mexico

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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’). 

Application V15a16

Of the Latin American countries, Mexico was the first to adopt off-patent biologicals (in 1999), followed by Colombia (2006) and Brazil (2014) [1].

A review in 2019 of the biosimilars market in Latin America [2] found that Argentina, Brazil, and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in other countries was more limited. Mexico was the biggest exporter of pharmaceutical products among the Latin American countries in 2015, however, Brazil is also a major global drug producer [3].

The review recommended investment in biotechnology hubs and further development of regulation on biological drugs [2].

The newly published Decree, effective as of 1 June 2021, 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:

  1. to obtain MAs for biosimilars
  2. to transfer all MAs
  3. to renew all MAs, and
  4. to deplete inventory after any MA modification.

It also introduces new requirements for the labelling of medicines placed in the public health sector.

In more detail, the main changes introduced by the Decree include the following:

  1. 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)
  2. It accepts that supporting documents, submitted with applications, can now be filed in English, without an official translation to Spanish
  3. It eliminates the participation of the Subcommittee for the Evaluation of Biotech Products (SEBP) from the approval process of biosimilars
  4. It eliminates the step of defining a biocomparability test prior to authorizing indications, including its extrapolation
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. It transforms fundamentally the process to assign MAs, from requiring an approval of the MA (administrative) modification to requiring only a notification
  11. 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
  12. It eliminates multiple references to the Third Authorized Parties for the review of dossiers, signalling the disappearance of this useful but criticized stakeholder.

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.

The modification reflects some of the recommendations from Latin American Forum of Experts in multiple sclerosis published in 2019 [4], facilitating the strictly apply current regulations for biosimilar products and complex non-biological molecules, as one of the recommendations by the Forum.

Editor’s comment
If you would like to receive a copy of the decree (Reglamento de Insumos para la Salud, ‘RIS’), please email us.

Related articles
Mexico trade deal impacts biologicals exclusivity

Guidelines for biosimilars around the world

Mexican guidelines for biocomparables


The brand-new section the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. 

View this week’s headline article: Un nuevo decreto modifica varios aspectos del sistema de aprobación regulatoria de biosimilares en México

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.


Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Vea el artículo principal de esta semana: Un nuevo decreto modifica varios aspectos del sistema de aprobación regulatoria de biosimilares en México

Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. Prices for arthritis biologicals in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from: www.gabionline.net/Biosimilars/Research/prices-for-arthritis-biologicals-in-latin-america 
2. Ortiz-Prado E, Ponce-Zea J, Vasconez JE, et al. Current trends for biosimilars in the Latin American market. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(2):64-74. doi:10.5639/gabij.2020.0902.011 
3. GaBI Online - Generics and Biosimilars Initiative. The biosimilars market in Latin America: a summary [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from: www.gabionline.net/Biosimilars/Research/The-biosimilars-market-in-Latin-America-a-summary 
4. GaBI Online - Generics and Biosimilars Initiative. Recommendations for similar biotherapeutic products published by Latin American MS experts [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 25]. Available from:

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