Joint API inspection pilot a success, says EMA

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Food and drug administration

The European Medicines Agency (EMA) says 12-month API plant joint inspection programme has fostered greater collaboration between international drug industry regulators and cut the number of duplicate visits.

The scheme, which has seen the agency collaborate with the US FDA and Australia's TGA, was the subject of some raised eyebrows in the trade press after a recent interim​ report revealed that, to date, only seven joint inspections have been completed.

Other observers focused on the number of duplicate inspections, at least 10, that have taken place despite the avoidance of such wasted regulatory effort being a driver for both the development of the project in the first place and one of the metrics identified early on as a way of measuring its success.

However, such concerns only reflect part of the overall programme according to EMA spokeswoman Sabine Haubenreisser, who told Outsourcing-pharma the project’s aim was to boost cross border collaboration as well as to increase the number of joint inspections.

The project has been a success​,” Dr Haubenreisser continued, adding that “much media attention seems to be given to the joint inspection activity overlooking the other equally important parts of the project​.

This contention fits with the interim report's wider conclusions, which highlight the 1,046 separate inspections that have been carried out and an increase in the level of information exchanged as key achievements and indicators of progress.

The report also suggests that the assessments, which have already been compiled into a "master list," could be used in the design of future Eudra good manufacturing practices (GMP) modules for shared inspection planning.

Decrease in duplicate inspections “self evident”

Dr Haubenreisser also said that while some sites had been assessed more than once, “it is self evident that a number of duplicate inspections have been avoided through either a joint inspection or the sharing of reports​.

We are in the process of looking at lessons learned by reviewing feedback provided by the partners. The EMA has noted that there is a need for an improved shared inventory of sites of common interest and supporting software applications and a need for longer planning lead times to arrange joint inspections​.”

The 12 month pilot scheme is due to end at the end of next month and, according to Haubenreisser “a final report will be published thereafter in the first quarter of 2011​.”

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