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COFEPRIS Introduces Changes to Drug Registration Process in Mexico

The Mexican health authority, COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), has a new drug registration process that went into effect in January 2023 in Mexico. The new process is designed to be more efficient and transparent, and it includes a number of changes from the previous process.

Here are some of the key changes to the drug registration process in Mexico:

  • The new process is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. This means that the requirements for drug registration in Mexico are now more aligned with the requirements in other countries.

  • The new process includes a pre-submission consultation meeting with COFEPRIS. This meeting allows the applicant to discuss their drug registration dossier with COFEPRIS before submitting it, which can help to expedite the review process.

  • The new process includes a single review team for all aspects of drug registration. This means that the applicant only has to deal with one team of reviewers, which can help to streamline the review process.

  • The new process has shorter review times. The average review time for a new drug registration dossier is now 12-18 months, compared to 24-36 months under the previous process.

The new drug registration process in Mexico is a positive step towards ensuring that safe and effective drugs are available to Mexican patients more quickly. The process is more efficient and transparent, and it includes a number of changes that are designed to streamline the review process.

Here are some of the key documents that need to be submitted as part of the new drug registration process in Mexico:

  • Sanitary Registration Application: This is the main document that is submitted to COFEPRIS. It includes information on the drug's safety, efficacy, and quality.

  • Clinical Trial Report: This document reports the results of the clinical trials that were conducted to support the drug's safety and efficacy.

  • Manufacturing Information: This document provides information on the drug's manufacturing process.

  • Labeling and Packaging Information: This document provides information on the drug's labeling and packaging.

The new drug registration process in Mexico is a complex process, but it is designed to ensure that safe and effective drugs are available to Mexican patients. If you are interested in registering a drug in Mexico, you should contact a qualified regulatory affairs consultant to help you through the process.


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