Teamwork future of GMP inspections, says EMEA
Under a pilot scheme launched late last year US, European and Australian drug regulators have begun pooling information about inspection plans to see if duties can be shared, in a bid to share the burden of international assessments.
In recent years the regulators have struggled to keep pace with good manufacturing practice (GMP) inspection requirements as, increasingly, drugs sold in their respective territories are being made elsewhere.
The US Food and Drug Administration (FDA) in particular has seen demands on its inspection teams increase as global drugmakers seek to tap into the world's leading market and major local pharmaceutical firms adopt outsourcing strategies to reduce costs.
This strain has meant that international inspections have not been without problems. In October for example the US Government accountability office (GAO) criticised the FDA for both failing to keep accurate data on plants inspected overseas and for not re-assessing those it had issued with warnings.
As a result, some groups have voiced concerns that any collaboration between agencies would impact on quality. Speaking to The Australian Thomas Faunce, from the Australian National University's Schools of Law and Medicine, asked whether the FDA was capable of effectively inspecting facilities making drugs that would be sold in his country.
Prof Faunce opined that: "Any process by which the TGA accepts US Food and Drug Administration approval - instead of its own analysis - will ultimately weaken its expertise," and suggested that instead the TGA should be building up capacity for inspections.
In an interview with in-PharmaTechnologist, European Medicines Agency’s (EMEA) International Liaison Officer Emer Cooke defended the collaborative approach as having “great potential for better and more efficient use of international regulatory resources”.
Cooke added that if the scheme progresses further the EMEA's EudraGMP database, the next release of which includes capacity for sharing inspection plans, “could be a valuable tool for sharing inspection plans with regulators outside the EU.”
Similarly, she predicted that the FDA's compliance status database (COMSTAT), which is shared with the EMEA and Australia’s Therapeutic Goods Administration (TGA), could play a similar role.
Cooke added that the drug industry would also see significant cost savings if regulators relied on inspections carried out by other regulatory bodies.
Cooke concluded that the success of the scheme is dependent on the willingness of the agencies to collaborate fully and adopt an open, pragmatic approach. She explained that reducing the amount of duplicate inspections was a critical first step in the process and added that: “cooperation, not competition is the key.”
