Irish Medical Times Medical News for Healthcare Professionals
There were 80 clinical trials for human medicines approved to commence in Ireland in 2014 compared with 102 the previous year, indicating a continuing drop, according to the Health Products Regulatory Authority (HPRA).
There were 10 applications for clinical investigations of a medical device, a level of activity broadly similar to the previous 12-month period.
In the area of human medicines, the HPRA assessed 179 new national applications (including parallel product authorisations), 40 applications via mutual recognition procedures (MRP) and 265 via decentralised procedures (DCP).
“The total number of new products authorised continues to decrease relative to previous years and this is reflective of a trend throughout Europe, which has been attributed to product patent lifecycles,” Chief Executive at the time Pat O’Mahony stated in HPRA Annual Report 2014.
Continuing its active contribution to the European human medicines licensing system, the HPRA acted as reference (lead) Member State for the assessment of seven MRP and DCP procedures. The Authority was also allocated as rapporteur or co-rapporteur for eight new marketing authorisation applications (MAAs) by the European Medicines Agency (EMA). Based on 2014 allocations, the HPRA is ranked as fifth in the EU for rapporteurships for centrally authorised human products. It acted as lead in 42 scientific advice procedures for medicines proposed for the treatment of a broad range of conditions.
Over the course of 2014, the HPRA issued 13,205 variations to MAs for human products authorised through the national or MR procedures. This reduction of 25 per cent in the volume of variations issued is due to the implementation of a new work-sharing procedure for national variations, which came into effect in 2013. Of note, at a European level, HPRA acted as rapporteur for eight paediatric Article 45 procedures and 13 procedures relating to Paediatric Investigational Plans (PIPs).
There were a total of 361 notifications to the medical device register while 26 organisations registered with the HPRA as Irish-based manufacturers of medical devices. A total of 117 manufacturers’ licences were in place at year-end for human and veterinary medicines. There were four authorisations for blood establishments and 24 for tissue establishments.
lloyd.mudiwa@imt.ie
