Out-Law / Your Daily Need-To-Know
Drugs manufacturers in Ireland can expect fewer regulatory inspections of their manufacturing practices after a US regulator announced it is happy to rely on conclusions reached by Ireland's Health Products Regulatory Authority (HPRA), a life sciences expert has said.
Karen Gallagher of Pinsent Masons, the law firm behind Out-Law.com, said the announcement, confirmed by the HPRA, would be welcomed by Ireland's pharmaceuticals industry.
"This will reduce costs for Irish-based pharmaceutical manufacturers of human medicines as it will reduce the number of inspections taking place at their facilities," Gallagher said.
In a statement, the HPRA said the new arrangement has been reached with the US Food and Drug Administration (FDA) under a broader mutual recognition agreement put in place between the EU and the US last year.
That mutual recognition agreement allows EU drug authorities to rely on the outcomes of inspections of US-based drugs manufacturers by the FDA, and similarly allows the FDA to recognise and accept 'good manufacturing practice' documents concerning the outcomes of inspections carried out by EU drug authorities that it has satisfied itself meet the standards it applies.
According to the Irish authority, the FDA assessed that the HPRA "has the capability, capacity and procedures to carry out [pharmaceutical good manufacturing practice] inspections at an equivalent level".
There are still circumstances in which the FDA can carry out its own inspections of EU premises of drugs manufacturers under the mutual recognition agreement, while the manufacture of medicines not in scope of the agreement, which currently includes veterinary medicines and some human medicines, will also remain subject to multiple potential inspections.
However, the HPRA said its inclusion on the FDA's list of approved EU authorities "should result in … reduced number of FDA inspections of manufacturers located in Ireland; reduced number of HPRA inspections of US manufacturers; improved efficiency of assessments involving contract manufacturing sites based in the US; [and] increased inspection resources available to inspect in other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured."
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