Medicinal Products

Drug Product Registration in Mexico – Overview

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) is Mexico’s national health authority. It protects the population against health risks arising from the use and consumption of goods and services, health supplies, as well as exposure to environmental and occupational factors, public health emergencies, and the provision of health services, through regulation, control, surveillance, and sanitary promotion.

COFEPRIS operates through regulatory, control, and sanitary promotion actions, within the framework of current health legislation and international best practices. These activities are supported by scientific evidence, technical capacity, and professional ethics, using a risk-based, process-oriented approach, in collaboration with federal and local health authorities, while promoting best regulatory practices.

Through its specialized areas and commissions, COFEPRIS plays a key role in evaluating the safety, efficacy, and quality of medicinal products, granting marketing authorizations, and overseeing the quality and safety of products available in the Mexican market.

Classification of Medicinal Products in Mexico

Medicinal products are classified into the following categories.

• Chemical Synthesis Drugs (New Drug/New Chemical Entity and Generic Drug).
• Biological (New Entity and Generic Drug).
• Biotechnological (New entity and Biosimilar).
• Traditional Herbal Medicines.

Medicinal Product Registration in Mexico

Drug registration in Mexico is carried out in the following steps:

Note - For a foreign manufacturer, it is mandatory to have an authorized representative to handle Pharmaceutical Regulatory Affairs in Mexico.

A) Marketing Authorization Steps

• Submission of the application for “Operation Notice’’ by official platform DIGIPRIS
• Submission of the Marketing Authorization Application (MAA) and pharmaceutical dossier preparation.
• Validation, assessment, testing, and evaluation by the relevant departments of the COFEPRIS.

B) Verification and Abridged Procedure

This process will be applicable if the product has been approved and marketed by any of the following entities:

• The United States Food and Drug Administration (USFDA)
• Health Canada
• The European Medicines Agency (EMA)
• The Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and
• The Australian Therapeutic Goods Administration (TGA), or
• Another entity recognized by the COFEPRIS.

C) Waiver of Onsite GMP Inspection

Onsite GMP inspection can be waived if the manufacturing facility is approved by a COFEPRIS-recognized entity such as:

• The USFDA
• The EMA
• Health Canada
• The PMDA of Japan, and
• The Australian TGA, or
• Another entity recognized by the COFEPRIS.

However, prior to importation, the local agent must obtain an import permit for each shipment from COFEPRIS, as part of the pharmaceutical importation process in Mexico.

Product Maintenance and Compliance

Pharmacovigilance 

At Freyr, we are committed to patient safety and regulatory management; therefore, pharmacovigilance constitutes an essential component of our service portfolio, aligned with the requirements of the applicable health regulations in Mexico.

In Mexico, pharmacovigilance activities are regulated by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) by Evidence and Risk Management Commission These activities include, among others:

• Receipt, management, and reporting of Individual Case Safety Reports (ICSRs).
• Preparation and submission of Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports (PSUR/PBRER).
• Literature monitoring.
• Development of Risk Management Plans (RMPs).
• Post-marketing surveillance studies.
• Safety signal detection and management.
• Additional pharmacovigilance activities, when applicable.

Pharmaceutical companies must have a pharmacovigilance unit constituted, and all pharmacovigilance activities must be overseen by a local person responsible for pharmacovigilance, duly appointed in accordance with COFEPRIS requirements.