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Mexico: New evaluation option for new compositions

In February 2017, new guidelines were published by the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS) that should be followed by medicaments or drugs considered as new molecules before the new molecules committee for evaluation, including the non-person modalities.

Such guidelines define if a drug or medicine should be evaluated under the person modalities or non-person modalities, according to the current law and the risk, complexity or nature of the product.

It is worth mentioning that the committee of new molecules for evaluation define that a new molecule is a natural or synthetic substance that is an active drug in a medicine, not previously used in Mexico, wherein the safety, effectiveness and therapeutic uses are not completely documented in the scientific bibliography.

On the other hand, consider that the previous practice to evaluate a medicine was under person modalities, wherein the applicant for a drug or medicine together with his committee appear before the New Molecules Committee presenting the information to support the quality, safety and effectiveness of product.

With the non-person modalities, the applicant should prove to COFEPRIS the information to support the quality, safety and effectiveness of a product to be evaluated without appearing before the Committee of New Molecules.

The considerations that the applicant should take into account about the characteristics of the product are:

a) first marketing authorisation in the world;

b) new marketing authorisation in Mexico (product authorised by other country);

c) new combination with a fixed dose; and

d) therapeutic indication (including: bordering of therapeutic indication, changes in the treatment line).

If the product was evaluated by some international sanitary agency with which COFEPRIS has an agreement, the applicant should consider the option of non-present modalities. Some such agencies are the Food and Drug Administration of USA (FDA), Health Canada, European Medicines Agency (EMA), Therapeutic Goods Administration (TGA) and the Swiss Agency for Therapeutic Products (Swissmedic).

Agustin Azcatl


Pedro Luis Ogazón No 17

Col San Angel

01000 México DF

Tel: +5255 53 22 30 00

Fax: +5255 53 22 30 01

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