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EGA expects 'commonalities' in EU and US shortage mitigation plans

By Gareth MacDonald+

08-Jan-2014

Reporting rules designed to prevent drug shortages are likely to be similar in Europe and the US according to the industry group that represents European generic drugmakers. 

The problem of drug shortages has come into sharp focus over the last few years as a result of manufacturing quality problems at key suppliers like Ben Venue and various firms ceasing production of certain drugs for economic reasons.

As a result regulators on both sides of the Atlantic have been trying to develop systems to prevent such problems. In 2012 the European Medicines Agency set out its plan in a consultation document and – in November – the organisation launched an online shortages catalogue .

In the US the FDA published its plan in November.

The only comment the FDA received by the January 3 deadline was from the US Generic Pharmaceutical Association (GPhA) which – while largely in favour of the measures – did voice some concerns about proposed reporting requirements .

GPhA supports the stated goal of the FDA to “improve FDA‟s ability to identify potential drug shortages and to prevent or mitigate the impact of these shortages.” We do have concerns, however, with the proposal to add a five business day time limit for instances in which it is not possible to provide the notice required by FDASIA at least 6 months prior to the triggering event.

We are concerned that in some instances it may not be feasible for the manufacturer of a drug to comply with this. In addition, it could have the unintended consequence of forcing drug manufacturers to report an interruption in manufacturing at the 5 business day mark even if at that time the manufacturer does not have sufficient information to determine whether the interruption is likely to lead to a meaningful disruption in the supply of that drug.”

Instead, the industry group proposed that rather than the 5-day limit interruptions should be reported “as soon as practicable" and said that its discussions with the FDA are continuing.

GPhA’s European counterpart – the European Generic Medicines Association (EGA) – is also talking to regulators about reporting requirements according to Julie Marechal-Jamil, senior manager of quality and regulatory affairs.

She told in-Pharmatechnologist.com that: “From an EU perspective, we, the representative body of the generic and biosimilar medicines manufacturers in Europe, alongside other stakeholders, including the EMA, are undertaking a collaborative effort with a view to achieve, among other deliverables, an optimal reporting process on shortages due to quality and manufacturing issues.

It is expected that aside specificities linked to the varying legal and regulatory frameworks, best practices will be identified and will show a great level of commonalities in both the EU and USA.”

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