Increase in medicine adverse reaction reports – HPRA

As in previous years, the majority of adverse reaction reports were notified to the HPRA by pharmaceutical companies in the context of their regulatory reporting obligations.

Meanwhile, other data in the HPRA’s report showed the authorisation of 637 new human medicines during 2016 (806:2015) while it also issued 14,207 variations to marketing authorisations for human medicines (15,691:2015).

Some 108 clinical trials of human medicine products were approved to commence in 2016, the same number approved in 2015.

Elsewhere, 4,054 enforcement cases were initiated (3,677: 2015) while 673,906 dosage units of illegal medicines were detained during the year (1,136,494: 2015). The illegal products detained included sedatives (40 per cent), anabolic steroids (16 per cent) and erectile dysfunction medicines (14 per cent).

Some 2,216 medical device vigilance reports were received and assessed during 2016 (2,126:2015). Surgical devices, orthopaedic devices and infusion devices accounted for 42 per cent of the total vigilance reports. The HPRA also investigated 335 market surveillance cases with the number of medical device cases it assesses on an annual basis having doubled since 2012.

According to Dr Lorraine Nolan, Chief Executive of the HPRA, 2016 was the first year of the organisation’s Strategic Plan 2016-2020.

“During 2016, the HPRA witnessed a number of milestones in our continued development as the national health products regulator,” she said. “We launched our Innovation Office to support academia and entrepreneurs in the development of novel health products; we carried out our first ever public information campaign which urges members of the public to take medicines safely and we marked the 50th anniversary of the establishment of the National Drugs Advisory Board, the precursor to the HPRA today. The outcomes and achievements during 2016 are evident from the contributions we have made at both national and EU level in protecting public and animal health.”