Cites strength of relationship with the Health Products Regulatory Authority for business continuity
Ireland has stepped up its bid to host the European Medicines Agency (EMA), following the exit of the current host country, the UK, from the European Union (EU).
The next step will see the Irish capital, Dublin, scrutinised closely, particularly in regard to its regulatory capability.
Ireland’s strength lies in the close relationship that the Health Products Regulatory Authority (HPRA) has established with the EMA and the wider network of medicines regulatory agencies throughout the EU.
The HPRA has been an integral part of this regulatory system since the EMA was founded more than two decades ago. It protects and enhances public and animal health in Ireland by regulating medicines, medical devices and other health products.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) contributes significantly to the processes that the EMA runs on an EU level; this strong, established working relationship will need to be replicated with the future host country of the EMA.
If the Agency relocates to Dublin, the closer working proximity will mean we can deliver business continuity, which is critical.
Consequently, the link with a country’s regulator will be an important consideration when the EU comes to decide on the EMA’s next location.
Ireland is already recognised as a prominent player in this respect. The HPRA holds established leadership positions within the EMA and is regarded as a significant contributor at many levels.
The HPRA has achieved significant senior representation within the key EMA scientific committees and currently holds the position of Chair of the Committee for Medicinal Products for Veterinary Use (CVMP) and Vice-Chair of the Pharmacovigilance Risk Assessment Committee (PRAC).
Lorraine Nolan, Chief Executive of the HPRA, is currently a member of the Management Board at the EMA where she is joined by her Deputy Chief Executive, Rita Purcell. Nolan said:
“Dublin is in many respects the natural destination for the EMA. If the Agency relocates to Dublin, the closer working proximity will mean we can deliver business continuity, which is critical, given the EMA’s role in securing the public health of citizens across the EU.”