News Category: Regulatory news
The HPRA today publishes its 2019 annual report, detailing its activities to protect and improve the health of people and animals across Ireland through the regulation of medicines, medical devices and other health products. The report outlines the HPRA’s extensive programme of work in each of the product areas it regulates, as well as highlighting how the national regulator responded effectively and rapidly to significant external developments impacting the wider health sector.
During 2019, the HPRA’s key activities included:
- The authorisation of 295 new human medicines for the Irish market through the national, mutual recognition and decentralised procedures. An additional 138 medicines were authorised through the centralised route (co-ordinated by the European Medicines Agency - EMA).
- The authorisation of 127 new veterinary medicines for the Irish market through the national, mutual recognition and decentralised procedures contributing to the record figure of approximately 1,850 veterinary medicines now authorised for the Irish market.
- Approval for 88 clinical trials of human medicines to commence (2018: 100).
- The review of five new applications to conduct clinical investigations of medical devices in Ireland with ten amendments to ongoing investigations.
- Issuing 125 human medicine recalls (2018: 196), as well as seven recalls related to veterinary medicines (2018: 6).
- The detention of 1,018,678 dosage units of fake and other illegal medicines (2018: 619,213).
- The processing of 6,167 individual enforcement cases (2018: 4,532). Additionally, eight prosecutions were initiated relating to the unauthorised supply of prescription medicines, including falsified anabolic steroids and erectile dysfunction products.
- Undertaking 110 good manufacturing practice (GMP) inspections at manufacturing sites producing human and veterinary medicines, and active substances across Ireland (2018: 116). The 2019 compliance programme also included inspections of 24 tissue establishments and seven blood establishments.
- The receipt of 9,253 adverse reaction reports in relation to human medicines, as well as 347 suspected adverse reactions and events reported in relation to veterinary medicines.
- The receipt and assessment of 2,295 medical device vigilance reports (2018: 2,358). There were 1,645 market surveillance cases undertaken during the year.
- Evaluation of 287 surveillance cases as part of the work programme to monitor the safety and quality of cosmetic products.
At a European Union level, HPRA scientific and technical staff again participated in a broad range of committees and working parties. Contributions during 2019 included:
- Acting as the lead member state for monitoring the safety of 49 nationally authorised active substances in addition to 52 centrally authorised human medicines as part of its contribution to the work of the Pharmacovigilance Risk Assessment Committee at the EMA.
- Serving as rapporteur for five applications and as co-rapporteur for 12 applications under the centralised authorisation route for new human medicines. The HPRA was also the co-ordinator of 102 EMA scientific advice requests across a broad range of conditions. As a result, in terms of national competent authorities for human medicines, the HPRA was among the top five contributors for lead assessment of centrally authorised products and scientific advice in Europe.
- Serving as rapporteur or co-rapporteur under the centralised route for 24 veterinary medicines while also acting as reference (lead) Member State for the assessment of 13 mutual recognition, 38 decentralised and nine repeat use procedures. As a result, the HPRA was the leading national competent authority in the EU in respect of outgoing work for veterinary medicines during 2019.
- Providing experts to participate in three joint assessments of medical device notified bodies in other European countries.
- Re-election to the Executive Group of the Competent Authorities for Medical Devices (CAMD) network.
Dr Lorraine Nolan, Chief Executive of the HPRA, said that in 2019 the agency continued to focus on protecting consumer and animal health through a risk-based regulatory approach.
“As an agency whose primary purpose is to protect and improve the health of people and animals through the regulation of medicines and devices, I am proud of what the HPRA and its staff have achieved in 2019. Of particular note was our increasing contribution as a lead agency for the centralised assessment of new human and veterinary medicines at the EMA. We also served as the co-ordinator of an increasing number of EMA scientific advice requests. This ongoing prioritisation and investment will ensure that the HPRA continues to deliver as a leading national agency within the centralised European system that enables access to innovative treatments and medicines for Irish patients and all European citizens.
“Over the course of 2019, we received more than 9,500 suspected adverse reaction reports related to human or veterinary medicines. Significant levels of reporting are particularly welcome, and we encourage healthcare professionals and the general public to report suspected side effects and any safety and quality concerns via our website using the online report forms. This information contributes significantly to the ongoing monitoring of medicines safety on the Irish market.
“2019 saw us once again continuing our work to stem the flow of counterfeit and falsified medicines and medical devices into Ireland and to protect the health of those who may be considering the use of these illegal products. Working with our partners in An Garda Síochána and Revenue’s Customs Service, we detained over one million dosage units of fake and illegal medicines coming into Ireland. With sedatives (34%), erectile dysfunction medicines (28%) and anabolic steroids (12%) making up the bulk of products seized in 2019, we continue to urge members of the public not to use unverified and unregulated sources to buy prescription-only and illegal medicines, including over the internet.
“Like many other State agencies and businesses throughout the country, Brexit was central to our work in 2019 and we continued to prepare for and effectively manage its potential impact. Working closely with the Department of Health, the HSE and stakeholders from right across the health sector – including manufacturers and distributors – we have and will continue to focus on ensuring minimum disruption to the supply and availability of medicines and medical devices for Irish patients.”
Looking forward, Dr Nolan said that COVID-19 had demonstrated the ever-evolving environment in which the HPRA operates.
“The international efforts to deal with COVID-19 are likely to be at the forefront of the sector we operate in over the coming years. The investments we have made in our people and processes, and the value we place on collaboration with our stakeholders, will ensure that we deliver on our commitment to serve as a trusted and progressive health product regulator in this new reality. I look forward to the HPRA and its staff continuing to set and deliver high standards in health product regulation and, through this, playing our part in delivering better care and outcomes for patients.”
Download the full report.
For further information:
Weber Shandwick PR (01) 679 8600
Barry Dunning / Seán Lawless (083) 167 4871 / (085) 116 7640