News Category: Regulatory news
The HPRA today published its 2017 annual report which details its key activities and progress across an extensive range of work programmes. It outlines the breadth of its outputs delivered in each of its health product areas with a core focus of protecting public and animal health. The report also highlights how effective the national regulator was in responding rapidly to external developments within the wider health care environment.
During 2017, its activities included:
- The authorisation of 684 new human medicines during 2017 (2016: 637) with 152 new marketing authorisations issued for veterinary medicines (2016: 126).
- 96 clinical trials of human medicine products were approved to commence in 2017 (2016: 108).
- The HPRA individually assessed and followed up 4,402 adverse reaction reports in relation to human medicines in 2017. In respect of veterinary medicines, there were 397 suspected adverse reactions and events reported and assessed during the year. The HPRA welcomes the commitment to reporting among healthcare professionals and the general public as the information received contributes significantly to the ongoing monitoring of medicines safety on the Irish market.
- A total of 82 human medicine recalls (2016: 201) and seven recalls relating to veterinary medicines products (2016: 8).
- The HPRA initiated 3,866 enforcement cases (2016: 4,054). 948,915 dosage units of illegal medicines were detained during the year (2016: 673,906). The illegal products detained included anabolic steroids (47%), sedatives (23%), and erectile dysfunction medicines (13%).
- 2,339 medical device vigilance reports were notified and assessed during 2017 representing 6% annual increase (2016: 2,216).
- 106 good manufacturing practice (GMP) inspections were undertaken at manufacturing sites producing human medicines and active substances. 12 GMP inspections were conducted at sites that produce or test veterinary medicines.
The HPRA’s active participation at EU level during 2017 included:
- As part of its contribution to the work of the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency (EMA), the HPRA was lead member state for monitoring the safety of 54 nationally authorised active substances in addition to 42 centrally authorised medicines.
- Serving as rapporteur for two applications and as co-rapporteur for 10 applications under the centralised authorisation route for new human medicines. A number of these applications were for biological medicines.
- The HPRA also served as rapporteur or co-rapporteur in the centralised route for 16 veterinary medicines.
- In addition, the HPRA provided experts to participate in four joint assessments of medical device notified bodies in other European countries. The HPRA has provided expert assessors to more EU joint assessments than any other European authority since the scheme was introduced in 2013.
According to Dr Lorraine Nolan, Chief Executive of the HPRA, 2017 was another significant year for the organisation. In addition to all areas and departments contributing to the delivery of a sizeable schedule of work, the HPRA also performed strongly in a number of external benchmarking programmes, validating its commitment to operate to the highest possible standards in delivering on its public health remit.
“As a regulator, external recognition of the effectiveness of our operating procedures and standards clearly endorses our strategic commitment to and investment in these areas. The confirmation by the FDA of the equivalency of our systems in relation to GMP inspections is a hugely significant development and we look forward to shortly participating as a recognised country under the US/EU mutual recognition agreement. Also during 2017, we received an excellent overall rating of 4.5 (out of 5) though BEMA, which is the benchmarking programme for European human and veterinary medicine agencies. The feedback and learnings from our BEMA audit will continue to drive our ambition to deliver the best possible outcomes for patients and members of the public.
“Investment in our internal capabilities and technical expertise was a key priority in 2017 and is a core tenet of our strategic plan. New and innovative medicines and medical devices are constantly emerging and while this presents challenges to us a regulator, it is also an opportunity for the HPRA to further enhance our specialist innovation supports. Throughout 2017, there was a focus on developing and attracting expertise in the areas of software, analytics and new fields of clinical interest.
“Also from last year, we are particularly proud of our participation in a number of new engagement platforms that enable us to work more directly and fulsomely with patients and patient representatives. This included participating as an education partner in the first nationally developed patient education programme which was led by the Irish Platform for Patient Organisations, Science & Industry (IPPOSI). Through our role as Vice-Chair of the Pharmacovigilance Risk Assessment Committee, we were also centrally involved in the organisation and delivery of the EMA’s first ever public hearing which was designed to give EU citizens a voice in the evaluation of the safety of their medicines.” she explained.
Looking forward, according to Dr. Nolan, the HPRA is ever conscious that it faces a range of opportunities and indeed challenges in the coming years in addition to its existing and extensive work programmes: “Our investment in developing internal capabilities and resources, our commitment to patient and broader stakeholder engagement, and our focus on supporting innovation, positions us well as we continue on our journey to positioning the HPRA as a regulator of the future.”
Annual Report 2017 / Tuarascáil Bhliantúil 2017
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