Mexico City /
Through a presidential decree published in the morning edition of the Official Gazette of the Federation (DOF), various guidelines of the Health Supplies Regulation were repealed and modified, to guarantee the health of Mexicans by regulating medicines.
As of June 1, the labels of medicines destined exclusively for public health and social security institutions must be differentiated from those destined for the private sector. In addition, they must include the legend “forbidden its sale” and contain the code of the National Compendium of Health Supplies, according to the modifications of article 26.
The Ministry of Health (Ssa) has 180 days, from today, to carry out these regulatory modifications. And in the case of manufacturers or establishments whose medications do not comply with said modifications, they will have 120 calendar days to exhaust their existence.
Among other modifications that established said regulation is that the documents that accompany the applications to obtain the sanitary registration must be written in Spanish or English and those issued in other countries will be apostilled or legalized, and once the biotechnological or biocomparable has demonstrated its biocompativity, it will obtain said registration as long as the drug has the same pharmacodynamic effect.
According to the modifications to article 177 of the regulation, in vitro studies of these drugs will not be required if the Ssa so determines based on the New Molecules committee.
Likewise, it establishes that when there is no relevant information in the Pharmacopoeia and its supplements, the SSA may evaluate biocomparability tests using information from international guidelines and clinical studies may be carried out in Mexico.
“An innovative biotechnological medicine or a biocomparable biotechnological medicine can be approved for use in other clinical indications, as long as there is scientific justification approved through clinical studies, determined by the Secretariat considering the opinion of the Committee on New Molecules”, states the document .
The secretariat will resolve the requests for modifications to the health registration conditions of any medicine within a period of forty-five business days, in case this does not happen within the aforementioned period, the request will be understood as appropriate and when more than one type of modification to the sanitary registry, the response time will be equal to the greater of those that are applicable.
The document also clarifies how the first extensions of the various drugs will be established, deadlines for submitting requests and response.