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.    

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