Overview:
On March 31, 2022, Mexico’s Health Authority COFEPRIS introduced a pilot program that will allow the pharmaceutical and medical device sectors to ask for regulatory guidance in a technical session concerning a variety of topics and will be held by COFEPRIS experts.
Which issues do the Sessions aim to resolve?
The Sessions aim to resolve concerns about any of the following procedures in a transparent and innovative way:
- Bioequivalences.
- Classification, import and storage of controlled drugs.
- Technical, legal, and administrative modifications to registration conditions and undefined requirements.
- Obtaining the Certificate of Good Manufacturing Practices for drugs, medicines, and medical devices.
- Processes linked to the release of biological drugs.
- Clinical protocols for Biotechnological and Orphans.
- Registry of Biotechnological and Orphans.
- Registration of Class III Medical Devices.
What does participation in the technical sessions not guarantee?
- The automatic authorization of your requests.
- Preferential treatment in the regulatory review process.
- Particular follow-up on the requests
Timelines & Fees:
- Once the form has been sent, it will be evaluated to see if it is “appropriate” and if so, a date will be assigned for the meeting.
- The request for a technical session is free of charge until COFEPRIS publish new information.
- It is important to consider that Cofepris will give priority to procedures that have not yet been entered, since the objective of the Technical Sessions is to guide the regulated industry (companies from pharmaceutical and/or medical devices sectors) to avoid queries or rejections due to the lack of understanding of the current regulations.
Rules to Consider about technical session
The companies that participate in a Technical Session are asked to consider the following guidelines:
- Personnel from the regulated sector who were not accredited in the request or confirmation of the meeting will not be allowed to enter the meeting.
- All technical sessions will be recorded.
- You can only talk about the topic for which the technical session was agreed.
- Personal information may not be exchanged between the technical areas and those regulated.
- Only one topic per session will be discussed.
- Questions will be answered whose answer helps to increase transparency in COFEPRIS procedures towards the regulated parties.
- This mechanism cannot be used to find out the status of procedures, since there is already a specific portal on the matter.
- If there is a need to give continuity to the interaction between the technical area and the company, this will be done through the Executive Directorate for Sanitary Promotion.
Questions? GRP team is ready to help you!
GLOBAL REGULATORY PARTNERS MEXICO IS LICENSED WITH COFEPRIS TO REGISTER:
- DRUGS
- BIOLOGICS
- MEDICAL DEVICES
- IVDS
- FOODS SUPPLEMENTS
- COSMETICS.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.