Drugdu.com expert's response:

The registration requirements for Active Pharmaceutical Ingredients (APIs) in Mexico typically involve a separate registration process, rather than simply being associated with the registration of the final dosage form. This is because APIs, as the essential components of dosage forms, have a direct impact on the quality, safety, and efficacy of the final product.

Registration Requirements for APIs in Mexico

Approval from the Mexican Ministry of Health: The export of APIs to Mexico requires approval from the Mexican Ministry of Health. This signifies that APIs must comply with Mexico's local pharmaceutical regulations and standards.

COFEPRIS Registration: Manufacturers of APIs need to register with the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which is the primary agency under the Mexican Ministry of Health responsible for regulating drugs, medical devices, cosmetics, and hygiene products. During the registration process, companies must submit a range of documents, including but not limited to GMP certificates, product specifications, manufacturing processes, quality control procedures, and more. These documents aim to demonstrate that the API's production process adheres to Mexican regulations and that the product's quality is reliable.

DMF Filing: Mexico has stringent requirements for APIs, often necessitating the submission of a Drug Master File (DMF). The DMF is a document submitted by the manufacturing company to the regulatory agency, detailing critical information about the API's manufacturing process, quality standards, quality control procedures, and more. Providing this information facilitates COFEPRIS's comprehensive evaluation of the API.

Other Certifications: Depending on the type of API, additional certifications may be required, such as GMP certificates, ISO certifications, CAS numbers, import/export licenses, etc. These certifications ensure the quality, safety, and compliance of the API.

Distinction Between Dosage Form Linked Registration and Standalone API Registration

Dosage Form Linked Registration: In some countries or regions, the registration of dosage forms may take into account the APIs they contain. However, this registration approach typically does not involve a detailed evaluation and registration of the APIs themselves. It focuses more on the overall quality and safety of the dosage form.

Standalone API Registration: As required by Mexico, APIs must undergo standalone registration. This approach ensures that the quality, safety, and compliance of the API itself are thoroughly evaluated and recognized. This is crucial for guaranteeing the quality and safety of the final dosage form.

In conclusion, Mexico's requirement for standalone registration of APIs, rather than associating them with the registration of dosage forms, underscores the country's high emphasis on pharmaceutical quality and safety, as well as its rigorous oversight of API production processes.