On December 15th, 2023, Cofepris published on its internet portal the “Guide for entering information for the Registration application of pharmaceutical products”, which specifies the information that must be submitted together with the drug products health registration application (allopathic, vaccines, blood products or biologicals), the characteristics of the information, as well as the order and format in which the information must be presented, all of this in harmonization with the Common Technical Document (CTD).
With the publication of the aforementioned guide, Cofepris formalizes the adoption of the CTD for the dossiers with which a registration of pharmaceutical products is requested in Mexico, and with this continues to advance in the implementation of the ICH guidelines, and in this way, it intends to comply with the commitments acquired upon being accepted as a member of ICH in November 2021.
But now that the CTD format is implemented, we are going to analyze the differences it has in the integration processes of the dossier for the registration of pharmaceutical products:
In reality, Cofepris continues to request the same information as before, it just changes the order in which it is presented:
Module I is administrative and legal information and it is specific by country. For Mexico, it includes the requirements that Cofepris has always requested without any changes, such as: legal documents, formats, endorsement letters, payments, operating notifications, licenses, GMPs, etc.
Module II is the following in the CTD format and corresponds to the summaries of the experts on the topics of quality, clinical and preclinical information; its implementation in Mexico is new and it is now part of the dossier, just as European manufacturers have it (in the case of foreign manufacturers). In the case of national manufacturers, they will have to generate these documents, which had not been requested until now.
Module III is the quality module, it includes the information on the drug, excipients and finished product and has the same structure as the international CTD, so products that are manufactured abroad, this module will be submitted to Cofepris as sent by the manufacturer of the product. In the case of national manufacturers, only the order in which the information is presented changes.
Regarding the information that Cofepris requested that does not correspond to the CTD format and that is not requested in other countries, such as: the batch records of the finished product batches used in stability, certificates of analysis of API and excipients issued by their manufacturers, corresponding specifically to the batches used in the manufacturing process of the batches used in the stability study (also called stability batch traceability); information on medical devices (when applicable), diluents and primary packaging. The authority continues to request it, but now it is presented in the Regional Information section.
Therefore, there were no changes in these requirements, since in many cases it is difficult or impossible for foreign manufacturers to provide traceability information, because in many countries manufacturing information is only kept for 5 years after the manufacturing date or expiration date of the product, depending on the country. So only in the case of new products can they be registered, and in the end the similarity with the CTD will continue to be partial and traceability will continue to be lacking.
Modules IV and V, correspond to preclinical information and clinical information, respectively, the main impact is how the information is organized for generic products and for new molecules. Previously, only general information or studies that specifically supported efficacy and safety were presented at the discretion of the applicant and now the type of studies that must be presented must be specified in detail.
As a perspective, we hope that the implementation of the CTD format will help speed up the resolution of new and pending applications for registration of pharmaceutical products, improving the response times that the Authority has officially established for the processing of registration applications of pharmaceutical products, and finally, the lag is eliminated.
However, Regional Information will now be the name of the new challenge, since in no other country where the CTD is used, traceability is a requirement for the registration of drug products and it is information that can only be obtained for products that have less than 5 years in which the batches of finished product for stability tests have been manufactured.
