As we are all aware the United Kingdom (UK) is beginning the painful Brexit divorce and separation from the European Union (EU) with a planned completion date of March 2019.
There are still many unknowns in this process, however one of the known outcomes of the Brexit decision is that the EMA (European Medicines Agency) will move from London to one of the other EU 27 states.
The Irish Government have proposed Dublin as the new location for the European Medicines Agency and have published a brochure outlining the reasons the Irish capital is the ideal location for the agency. View the brochure in full by clicking here.
What do the EMA do?
The EMAs main responsibility is the protection and promotion of public and animal health, by carrying out scientific evaluations of medicines for human and veterinary use. The outcome of the Agency’s evaluation is used by the European Commission (EC) to decide whether a medicine can be authorised for marketing in the European Union (EU). The company producing a medicine can only market it once the medicine has received a marketing authorisation from the EC.
In summary the EMA coordinate a pan-European approach to the Pharmaceutical/ Biotech industry by gathering data and offering technical and market knowledge and direction to the EC, member states and industry. The EMA may not be carry out facility audits however they set the standards and guidelines that form the basis for the inspection team.
The Irish state body with responsibility for the safety and regulation of the research, clinical trial, manufacture and sale of Pharmaceutical and Medical Device products for humans and animals in Ireland is the HPRA (Health Products Regulatory Authority). They work closely with the EMA and receive valuable insight and information on what is happening across the other 27 EU states.
Lorraine Nolan, Chief Executive of the HPRA said:
“Ireland is a recognised global leader in the life sciences and the HPRA has a strong relationship with the EMA. Our existing contribution to the work of the agency is significant for a country the size of Ireland and we are very well placed to continue providing that regulatory expertise with Dublin as the host city.”
You can find out full details on the Dublin’s bid to host the EMA at www.emadublin.ie
So, what is the process for bidding to host the EMA?
The deadline for Member States to submit formal bids to host EMA to the European Council is 31st July 2017.
The European Commission will examine the bids based on the agreed process and criteria for deciding on EMA’s new location and submit its assessment to the Council by 30th September 2017. A final decision on the location is expected before November 2017.
At LSC, we will be watching the process closely with great interest as to host the EMA would have a significant positive impact on the Irish Life Science industry and for those who work in it.
We will keep you posted on the latest updates on this story and other Life Science industry news here.