The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), or the Federal Commission for the Protection against Sanitary Risks, released Mexico’s first Regulatory Guidance Module on May 19, 2023. This innovative module was developed based on advice from the Internal Control Body, showcasing COFEPRIS’s institutional advancements in transparency, anti-corruption, and process optimization.

The module aims at advancing service capabilities and improving the efficacy of processes. It seeks to benefit users by providing clear instructions on preparing the Common Technical Document (CTD) for the registration of pharmaceutical drugs in Mexico. By offering concise advice, the module simplifies the review and approval process to a great extent.

COFEPRIS’s Regulatory Guidance Module can assist manufacturers in ensuring Regulatory compliance in Mexico’s pharmaceutical market. It extends support in the following ways:

  • Providing clear assistance to applicants in completing the CTD for the registration of pharmaceutical drugs in Mexico.
  • Informing applicants about the necessary steps they need to follow to be compliant with the regulations.
  • Streamlining the review and approval process by providing applicants with clear and concise guidance.
  • Ensuring compliance with medical device regulations for applicable modules.
  • Adhering to the Regulatory or statutory requirements specified in pre-market submissions for device software functions.
  • Complying with the Uniform Guidance, as provided in the most recent Office of Management and Budget (OMB) compliance supplement.

To sum up, the Regulatory Guidance Module helps applicants meet the Regulatory requirements by offering guidance and ensuring that they are aware of the measures they need to take to be compliant.

Complying with COFEPRIS regulations and navigating Mexico’s complex submission process can be a daunting task!  Freyr offers a range of Regulatory services, ranging from Notice to Applicants (NTA) to CTD conversions and labeling to medical writing, to meet your needs. To explore further, contact us today!