Posted on: 28th March 2018

BPOG is working together with Brazil’s ANVISA to help increase the rate at which approvals are made by up a year. The current approval timeline in Brazil is between 18 months and two years, it is the intention of the Post-Approval Strategies (PAS) workstream to reduce this and support ANVISA to harmonize their approvals with the International Congress for Harmonization (ICH) of which ANVISA are now members.

The PAS team has a strategy of direct engagement with regulators who have a history of long approval timelines and divergent, poorly defined regulatory requirements, where we have promising channels of engagement and as such, they held workshop with ANVISA in November 2017.

During the team’s educational workshop, the Biologics Review team manager asked the BPOG team to recommend revisions to their requirements for stability data, and submission of analytical method changes.  This is a unique opportunity. If accepted into law, these revisions will reduce approval timelines for changes involving stability data by about 12 months, and move about 30 per cent of analytical method changes from a category of ‘prior approval’, to ‘do and tell’ (effectively zero approval time).  The benefits for the BPOG membership, indeed the industry as a whole will be huge.

Kavita Ramalingam Iyer of Merck (MSD) fed back that: “[her]company colleagues recognized the potential to influence timeline reduction through direct engagement with ANVISA, and welcomed the insights into ANVISA’s ways of working that came from direct discussions with their review team.”

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