HPRA raises Brexit concerns: GMP mutual recognition & member state status

Earlier this year​, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) signed a mutual recognition agreement​ (MRA), which will come into effect next month.

The deal allows the EMA to refer to US FDA inspection good manufacturing practice (GMP) data, and vice versa, with the aim being to reduce duplicate audits. The agreement also allows the agencies to make the best use of resources.

At the BioProduction Congress held Dublin this week, Ireland’s Health Products Regulatory Authority (HPRA) said the UK’s role in the MRA, post-Brexit, is still unknown.

“We don’t know yet whether there will be a MRA in place with the UK, or whether they’ll be entirely considered as a third country ​[a country outside of the EU] of manufacturing,” ​said HPRA inspector Dearbhla Cullen.

The UK is due to leave the EU on March 30, 2019.

“Up until that date, the UK continues to play a full role with the EU network during the ongoing negotiations,” ​she added.

According to Cullen, firms that have the UK as their reference member state will benefit from the MRA while Britain remains in the EU.

However, it is not clear whether the agreement will continue to apply to manufacturers these after the UK withdraws from the European Union (EU), said Cullen.

Similarly, it is not clear how Brexit will affect companies with marketing authorisation holders, active substance manufacturing and finished product sites established in the UK, she said.

Ireland & the MRA​

Cullen said the FDA have been undertaking a joint assessment of regulatory bodies within the EU, in preparation for the MRA.

“HPRA underwent their assessment in May of this year, we were happy that it went well,” ​she said.

The FDA has not issued its report on the assessment, and consequently Ireland will not be in the first group of eight member states to be considered under the November 1 deadline, said Cullen.

“We do hope we will be in the member states that will be considered in the next phase, in hopefully mid-2018,” ​she added.