Drug Product Registration Process in Mexico – Overview
The Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS) is the primary Regulatory authority overseeing the drug product registration process in Mexico.
The drug department of the COFEPRIS is responsible for pharmaceutical Regulatory affairs in Mexico, including licensing, manufacture, import, export, distribution, promotion, and COFEPRIS registration of pharmaceutical products. It plays a key role in evaluating the safety, efficacy, and quality of medicinal products, issuing marketing authorization, and ensuring the safety of marketed drugs in line with Mexico drug Regulatory guidelines and the overall Mexico Regulatory framework.
COFEPRIS drug approval is a vital step in the drug product registration pathway, ensuring compliance with COFEPRIS drug registration guidelines and Mexico pharmaceutical regulations.
Drug Product Registration Process in Mexico: Classification of Medicinal Products
Medicinal products in Mexico are classified into the following categories:
- Chemical Synthesis Drugs (New Drug/New Chemical Entity and Generic Drug)
- Biological Products (New Entity and Generic Drug)
- Biotechnological Products (New Entity and Biosimilar)
- Traditional Herbal Medicines
Drug Product Registration Process in Mexico: Step-by-Step Guide
Drug registration in Mexico is carried out in the following steps:
Note - Foreign manufacturers must appoint an authorized local agent to handle pharmaceutical Regulatory affairs in Mexico.
A) Marketing Authorization
Steps:
- Submission of an ‘’Operation Notice’’ to the Centro Integral de Servicios (CIS)
- Submission of the Marketing Authorization Application (MAA) and pharmaceutical dossier
- Validation, assessment, and laboratory testing by COFEPRIS
- Product pricing review by the pricing department
- Final review by the registration committee for product license issuance
B) Verification and Abridged Procedure
This applies if the product is already approved and marketed by:
- USFDA
- Health Canada
- European Medicines Agency (EMA)
- Pharmaceutical and Food Safety Bureau (PFSB), Japan
- Therapeutic Goods Administration (TGA), Australia
- Any other entity recognized by COFEPRIS
C) Waiver of Onsite GMP Inspection
Onsite GMP inspection may be waived if the manufacturing facility is approved by any COFEPRIS-recognized regulatory authority mentioned above.
Import Regulations in Mexico
COFEPRIS permits importation of non-registered drugs in specific situations:
- Essential drugs
- Security/extraordinary cases
The local agent must acquire an import permit from COFEPRIS for each shipment, aligning with import regulations related to pharmaceutical drug registration in Mexico.
Product Maintenance and Compliance:
|
Sr. No |
Application |
Validity |
|
01 |
Validity for Registration Certificate |
Five (05) years from the date of registration |
|
02 |
Renewal of Registration certificate |
The renewal application should be submitted six (06) months before the expiration of the existing registration certificate |
|
03 |
Post Approval Changes (Variations) |
Any change of registered medicine should be sent to the COFEPRIS with relevant documents, on a case-by-case basis. |
Freyr Expertise in Mexico Drug Registration - Freyr Expertise
- Complete pharmaceutical drug product registration support
- Strategic Regulatory affairs consulting for market access
- Authorized local agent services
- Gap analysis per COFEPRIS drug registration guidelines
- Preparation of gap reports and remediation plans
- Dossier preparation & submission for COFEPRIS approval
- Lifecycle management & post-approval variation support
- COFEPRIS query handling
- Import permits and label compliance
- Support with advertising permits, drug marketing, and commercialization of medicines
- Label assessment and pharmaceutical artwork management
- Ad-hoc Mexico Regulatory consultation
Conclusion
Navigating the drug product registration process in Mexico requires a clear understanding of COFEPRIS regulations, classification criteria, and documentation standards.
Whether you are a domestic company or a foreign manufacturer, compliance with Mexico’s pharmaceutical regulatory framework is essential for successful market entry and product commercialization. With the right strategic guidance and local representation, companies can streamline approvals, minimize delays, and ensure full regulatory alignment throughout the lifecycle of their products.
