Overview:
On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.
Cofepris proposed three major changes included in the amendment. The changes included primarily, regards to extensions allowing for indefinite validity after the first five year; secondly accepting foreign clinical studies real world evidence (RWE) , thirdly, procedure no longer have to be translated to Spanish, English documents are allowed.
1. Changed to extensions
- Cofepris proposes to strengthen health surveillance and only require an extension after the first 5 years.
- After that, already having surveillance on the product, the validity would be
2. Interchangeability
- In addition to these changes, the health authority will accept clinical studies of origin for bio-comparable biotech drugs.
Changes to Clinical Trial Applications:
Changes for clinical trials application in Mexico have also occurred, which reduce deadlines for authorization applications and strengthen surveillance include :
- The authorizations of new protocols go from 90 days to 30 days.
- Amendments with an impact on the conduct of the study go from 90 to 20 days.
- Administrative amendments will be reduced from 90 to 10 days.
3. Procedures in English
- The Commission will now accept documents in Spanish or English, eliminating the high costs of a translation.
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 and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.