Both Guy Villax, CEO of Hovione, in a press conference and Janice Soreth, deputy director of the London office of the US Federal Drugs Administration (FDA), who was the keynote speaker at the EFCG Dinner, which was also held during CPhI, discussed GDUFA at length.
At the end of the five-year period, Soreth
said, the FDA
will be acting on 90% of complete electronic ANDAs within ten months, as opposed to an average of 31 at present.
It will also act on 90% of all the ANDAs and PAS pending on 1 October 2012.
Meanwhile, parity should be achieved between US and foreign API and FDF sites, with both receiving risk-adjusted biennial cGMP surveillance inspections.
Other key performance metrics will include the use of complete review-response letters, completeness assessments for DMFs that are intended to be referenced by the ANDA sponsors and division-level deficiency review and first cycle meetings for ANDAs and DMFs.
said, will also develop regulatory guidance for industry and take initiatives to enhance post-marketing safety.
"GDUFA is a welcome paradigm shift for all generic industry participants, regardless of size or geographic location, as well as consumers, with predictable review times and certainty of inspection for all facilities," she
updated the EFCG Dinner on the FDA's
moves to better inspection abroad
also recognised that FDA's record of inspecting abroad is inadequate and her
address to the EFCG Dinner detailed some of the ways it has been seeking to remedy this in recent years.
This summer, she
noted, a 24-month pilot programme of joint inspections with the European Medicines Agency
(EMA) and Australia's Therapeutic Goods
Administration concluded successfully.