The registration pathway for  biologics, or biotech , in Mexico is  essentially the same as for other drugs. Biologics must  prove to be safe and effective , in addition to this they must also  comply with a number of other  dossier requirements. The Dossier must include proof of  good manufacturing practices for medicinal products (NOM-059-SSA1-2013) and for active ingredients (NOM-164-SSA1-2013).

How Are Biologics Defined in Mexico?

A “biotechnological drug”  is defined as any substance produced by molecular biotechnology which has a therapeutic, preventive or rehabilitative effect, which is in pharmaceutical form, and which is identified as such by its pharmacologic activity and physical, chemical and biologic properties.

What Regulations exist for Biosimilar Registration?

 In Mexico, the applicable regulations for registration of Biosimilars include:

  • NOM-012-SSA3-2012
  • NOM-059-SSA1-2013 for GMP
  • NOM-072-SSA1-2012 for Labeling of drugs
  • NOM-117-SSA1-2013 for requirement of third parties for performing comparability studies

What are the different Registration Pathways for biologic products in Mexico?

Biological or Biotechnology products whether Innovators or generics/bio comparable (biosimilar) (local or foreign manufacturing), Orphan Recognition Certificate (Local or foreign Manufacturing), Vaccines can be registered under the pathway defined under the Biological/Biotechnology Products Pathway.

Registration pathways for Drugs in Mexico

Fast Track Pathways:

Bioequivalence agreements can be used where API not approved in Mexico but approved in USA, Canada, Switzerland, Australia, EU.

What is the registration process for  biologic/biosmilar in Mexico for a foreign manufactuer?

Registration with COFRPRIS with Prior Registration in Reference Country

Registration with COFRPRIS without Prior Registration in Reference Country

What are biologic / biosimilar COFEPRIS assessment timelines ?

  • Once the application is submitted, COFEPRIS takes about 180 calendar days  in Mexico for review of the dossier. In case of queries the duration may be extended.
  • Orphan Drugs take 60 business days but there is not an enabled prioritization scheme in Cofepris.

Are there provisions under which the review & approval be fast tracked for biologic / biosimilar products?

Different approaches need to be discussed with health authorities. In general following  products can be evaluated for possibility of fast track:

  • Specific Vaccines (BCG, Hepatitis B, Penta VIP/VOP, Pneumocócica 10V   –  Rotavirus Humano, Meningocócica C   –  Febre Amarela Hepatite A   –  Tríplice Viral   –  Tetra Viral, HPV –  Dupla Adulto   –  dTpa*)
  • New Products
  • Brand new generics – if there are not enough drugs available to treat the disease

What are the timelines for a license transfer in Mexico?

For license transfer, the steps include,

  • *Gap analysis of administrative and technical documents required for submission
  • Preparing and submitting application for license transfer
  • GMP certificate update
  • Updated label
  • Import license
  • Local representative with necessary sanitary license and business license

It takes about 9-12 months depending on Cofepris review timelines and readiness of documents. 

*GRP will provide a comprehensive list of administrative and technical documents required for submission.

What requirements must  Foreign Companies comply with to order to import and market a product in Mexico?

The Ministry of Health regulates all products affecting the human body in any way. That is: pharmaceuticals, vitamins, cosmetics and medical equipment/devices. Because of the nature of the products, they can only be imported and marketed in Mexico if the foreign company establishes a local Mexican manufacturing unit or local office, or if the foreign company appoints a Mexican legal representative who is able to market the products.

  • The representative must also be authorized by the Mexican authorities to import and distribute medical products.
  • The pharmaceutical company will declare the value of the shipment before sending the products and will provide its legal representative with all the documents as s/he will need them to support the declarations to Custom.

About Global Regulatory Partners:

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations..  To learn more, please contact us at  info@globalregulatorypartners.com

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