EDQM and Anvisa sign MoU on future use of CEPs in Brazil

By Gareth Macdonald

- Last updated on GMT

The EDQM and Anvisa have signed an agreement that may allow drug firms seeking clearance to sell products in Brazil to file CEPs in approval applications.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA announced the memorandum of understanding this week, explaining the aim is to build trust between the two organisations.

Drug companies and their active pharmaceutical ingredient (API) suppliers use Certificates of Suitability (CEPs) to show that their product's active substances comply with quality and purity specifications set out in the European Pharmacopoeia.

While the agreement does not mean Anvisa will consider CEPs in its evaluation of marketing authorisation applications (MAAs) at present, it sets the groundwork for their use in the future according to the EDQM.

The Strasbourg-based directorate said: “Confidence building activities will be essential for ANVISA to incorporate CEPs into its evaluation of MAAs​.”

The Memorandum will see the EDQM informing ANVISA on all actions taken in relation to CEPs or applications for CEPs, including reasons for GMP non-compliance, whereas EDQM inspection and quality assessment reports will be made available upon request by ANVISA​.”

The organisations have also agreed to share information on their respective review practices and organise technical workshops, site visits and joint comparison exercises on the suitability of CEPs.

An EDQM spokeswoman told us “the MoU lays the foundation for future use of CEPs in MA applications in Brazil. We know from experience that different countries/authorities take different approaches. In the past, some of them have decided to accept CEPs, sometimes together with the submission of additional information, within a rather short time-frame.

ANVISA has decided to take a stepwise approach and acquire a more in-depth understanding of the process and evaluation criteria before accepting CEPs​" she added.

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