The Executive Branch opened a consultation exempting drugs endorsed by internationally recognized agencies from evaluation in the CMN
2 diciembre 2021


On December 2, the Federal Commission for the Protection against Health Risks (COFEPRIS in Spanish), through the National Commission for Regulatory Improvement (CONAMER in Spanish), opened a public consultation to modify the operation of the New Molecules Committee (CMN in Spanish). This body is in charge of analyzing, in the first instance, the safety and relevance of allowing the commercialization of any new drug in the country. The aim of the text is, according to the entity, to make the management methods more agile and to make the committee’s processes more operational and efficient. The text will be available for public consultation until at least December 27 and interested parties can send their opinions through the following link.

The draft regulation comes to replace the Regulation issued in 2012 as well as its first amendment issued in 2018. Thus, the text under consultation proposes the following:

  • Clarify the scope of the functions of the CMN. Thus it includes the following:
    • Analyze technical scientific information related to the safety, quality and efficacy aspects of drugs containing in their formulation a new molecule, new combination that does not exist in the national market of two or more drugs, new therapeutic indication, new concentration, inclusion or modification of age groups, new pharmaceutical forms of drugs already existing in the market or new pharmaceutical alternatives.
    • To give priority attention to those new molecular entities that are a priority for public health, in accordance with the guiding principles of the National Development Plan and the National Health Program.
  • Regarding its operation, it allows the sessions to be carried out in a semi-presential or virtual manner. All sessions must be videotaped.
  • It allows more than one case to be analyzed in each session, always respecting the principles of economy, speed, efficiency, legality and good faith.
  • It establishes that the opinions issued by the Committee will not be binding and do not imply the authorization of the Sanitary Registration by COFEPRIS. Requests for technical meetings with the Committee will be scheduled under the criteria of emergency attention (catastrophes, epidemics or pandemics); priority inputs in public health, neglected and orphan diseases and finally by first in-first out.
  • Those products approved by other recognized agencies will not require a technical meeting with the Committee, except when the clinical information presented is controversial or there is a discrepancy between the resolutions issued by the recognized agencies. When a technical meeting is not required, the Committee will issue a special technical opinion stating that it does not need to be presented to the plenary.
  • The text, once the public consultation has been completed, will enter into force the day after its publication in the Official Gazette, and will repeal the previously issued regulation as well as its amendments.

What is the COFEPRIS New Molecules Committee?

The CMN functions as an auxiliary body for consultation and opinion prior to applications related to medicines and other health inputs. It is made up of experts in health regulation and issues technical opinions related to molecules that do not exist in the national market, or that are intended to be used in health research for human use. The opinion of the CMN is the previous step that any new drug must complete before being able to request the sanitary registration for such product before COFEPRIS.