In the current landscape of Mexican regulatory compliance, the opportunity for an open dialogue with the health agencies is a great asset. In order to strengthen communication channels between the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the regulated sector, a new mechanism known as Technical Sessions has come into play. This piece will provide an overview of this mechanism, as well as its guidelines and the topics that can be discussed during these sessions.
What is a Technical Session?
The Technical Session is a mechanism through which the regulated sector makes inquiries to clarify specific doubts regarding technical and regulatory provisions that apply to goods and services within the scope of competence of COFEPRIS.
A Technical Session may be requested to clarify technical and/or regulatory questions in the following scenarios:
- Before the submission of a new application.
- Doubts about preventions.
- Resolve questions about a negative response of an application.
It is important to note that Technical Sessions do not:
- Guarantee the authorization, prevention, or a negative response of an application.
- Generate preferential treatment in the ruling of an application
Additionally, Technical Sessions cannot be requested to know about the current status of an application in the process of being verified, or for reviewing an application before its official submission.
Technical Session Guidelines
When attending a Technical Session, the participants must adhere to the following guidelines:
- Access is only allowed for individuals from the requesting company who have been previously accredited.
- Discussion will be limited to the agreed-upon topic for the Technical Session.
- In the event that the session time expires and the requesting company believes that more discussions are necessary, a new session must be scheduled through the Sanitary Promotion Commission.
- If it is determined during the Technical Session that there is a need to continue the interaction between the technical area and the companies, a follow-up Technical Session must be requested.
- Personal information exchange between technical areas and regulated individuals present is not allowed; anyone found doing so will be reported to the Internal Control Body (OIC).
- All Technical Sessions will be recorded.
Technical Session Topics
Technical Session topics that can be discussed during the meeting:
- Bioequivalences
- Obtaining a GMP certificate
- Registration of biotechnological drugs
- Registration of orphan drugs
- Classification, importation, and storage of controlled drugs
- Clinical protocols for biotechnological drugs
- Clinical protocols for orphan drugs
- Registration of Class III medical devices
- Processes related to the release of biological drugs
- Modifications to registration conditions
- Sanitary permits for import and export
- Pharmacovigilance and other sessions with some undefined requirements
Related to the DigiPRIS digital platform:
- Issues with the Self-Service Procedures Platform DigiPRIS
Technical Session Application Process
In order to request a Technical Session:
- The company must send an email to sesionestecnicas@cofepris.gob.mx and explain, objectively and in detail, the topic to be discussed and the doubts or points to be clarified.
- COFEPRIS will respond to the email with the request form.
- Once the company submits the form, COFEPRIS will send an email with the following details:
- Topics to be addressed in the meeting
- Date
- Time
- Confidentiality letter
- Meeting confirmation request
Conclusions
Technical Sessions serve as a conduit, fostering understanding and facilitating a streamlined and informed regulatory process for all the parties involved. Providing access to a mechanism that serves to clarify regulatory doubts, COFEPRIS provides a productive and transparent environment between the regulated sector and the government, as well as delivering on enforcing their goals in regulatory certainty.
It is worth noting that it is not clear that, based on the COFEPRIS guideline, the topics to be discussed are limited, or it is possible to extend it to more cases. For instance, covering questions about Class I medical devices. We will be updating this article while we learn more about this in practice.
If you have any inquiries about Technical Sessions, please feel free to contact us at contact@veraqueconsulting.com.
