Mexico’s pharmaceutical industry is vibrant and growing, with strict regulations to ensure the safety and efficacy of drugs available to its citizens. Pharmaceutical companies aiming to bring their medicinal products to the Mexican market must carefully understand the drug approval process.

In this blog, we discuss thirteen (13) Frequently Asked Questions (FAQs) on medicinal product registration in Mexico based on the country’s Regulatory guidelines.

1. What is COFEPRIS, and what role does it play in Mexico’s medicinal product approval process?

The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), or the Federal Commission for the Protection against Sanitary Risks, is the central authority in Mexico that is responsible for regulating health products, including drugs, medical devices, and food. COFEPRIS oversees the entire drug approval process in Mexico, from the initial application to the Post-market Surveillance (PMS) stage.

2. What types of medicinal products are subject to registration in Mexico?

Medicinal products intended for sale or use in Mexico must be registered with COFEPRIS. This includes new drugs, generic drugs, biosimilars, and vaccines.

3. What are the different pathways for medicinal product registration in Mexico?

There are three (03) main pathways for medicinal product registration in Mexico, such as:

  • New Drug Registration: This pathway is applicable to New Chemical Entities (NCEs) that have not been previously marketed anywhere in the world.
  • Generic Drug Registration: This pathway is applicable to drugs that are equivalent to a previously approved reference drug in terms of safety, efficacy, and quality.
  • Biosimilar Registration: This pathway is applicable to biological products that are similar to a previously approved reference biological product.

4. What are the key steps involved in Mexico’s medicinal product registration process?

The key steps in the medicinal product registration process in Mexico are highlighted below:

  • A Pre-consultation Meeting with COFEPRIS: This meeting is mandatory for all new molecule applications, and it is strongly recommended for generic applications.
  • Dossier Submission: The applicant must send a comprehensive dossier containing all the necessary data and documentation to COFEPRIS.
  • COFEPRIS Review: COFEPRIS carries out the evaluation, with possible requests for additional information or clarification.
  • Site Inspection: This may include a facility inspection to ensure compliance with Good Manufacturing Practices (GMP).
  • Decision Issuance: COFEPRIS approves or rejects the application.

5. What are the Regulatory guidelines for clinical trials in Mexico?

Clinical trials must be conducted in accordance with the relevant Mexican regulations as well as international standards. Applicants must submit a Clinical Trial Application (CTA) to COFEPRIS for approval before initiating the trial.

6. What are the challenges of navigating the medicinal product Regulatory landscape in Mexico?

Some of the hurdles you need to overcome while navigating the medicinal product Regulatory landscape in Mexico include:

  • Complex and evolving regulations
  • Limited guidance documents
  • Long approval timelines
  • High costs

7. What is the first step toward getting your medicinal product approved?

First and foremost, classify your medicinal product! COFEPRIS uses a risk-based system, with Class I being low-risk and Class III posing the highest potential danger. This classification determines the testing and documentation requirements.

8. What documents do you need to submit to COFEPRIS for approval?

The dossier is your key to unlocking the COFEPRIS gates. It is a comprehensive document containing data on your drug’s safety, efficacy, quality, and manufacturing process.

9. How long does the approval process take?

The timeline of COFEPRIS’ approval depends largely on the complexity of your medicinal product and the chosen registration pathway. While the standard route can take up to one hundred and eighty (180) days, expedited options might be available for certain medicinal product categories.

10. What happens if COFEPRIS requests additional information?

In case COFEPRIS asks for additional information, do not panic! COFEPRIS provides clear communication channels and timelines for addressing any queries or deficiencies in your dossier.

11. Can I appeal a COFEPRIS decision?

Absolutely, you can! You have the right to challenge any unfavourable decision through a well-defined administrative process.

12. Does COFEPRIS offer any guidance or support to applicants?

Yes, COFEPRIS provides various resources, including online guides, workshops, and consultations, to help you navigate the medicinal product registration process smoothly.

13. What are the post-approval requirements for your medicinal product?

COFEPRIS closely monitors your medicinal product’s performance even after it has been given approval. You will have to submit periodic safety reports and comply with any necessary labeling changes.

Do not let Regulatory hurdles hold you back! Contact Freyr today and let our experts guide you toward a successful drug registration in Mexico.


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