News Category: Regulatory news
The HPRA today published its 2020 annual report, detailing its activities to regulate medicines, devices and other health products for the benefit of people and animals. The report outlines the HPRA’s programme of work in each of the health product areas it regulates, as well as highlighting how the national regulator responded effectively and rapidly to significant developments, including COVID-19.
During 2020, the HPRA’s key activities included:
- The authorisation of 251 (2019: 300) new human medicines for the Irish market through the national, mutual recognition and decentralised procedures. An additional 155 medicines were authorised through the centralised route – co-ordinated by the European Medicines Agency (EMA) – with the HPRA serving as rapporteur and co-rapporteur for 12 and six applications, respectively.
- The authorisation of 57 new veterinary medicines for the Irish market through the national, mutual recognition and decentralised procedures contributing to the record figure of approximately 1,880 veterinary medicines now authorised for the Irish market. The HPRA also served as rapporteur or co-rapporteur under the centralised route for three veterinary medicines while also acting as reference (lead) Member State for the assessment of three mutual recognition, seven decentralised and 14 repeat use procedures.
- Approval for 73 clinical trials of human medicines, including seven COVID-19 related trials.
- The receipt of 7,752 adverse reaction reports in relation to human medicines, as well as 391 suspected adverse reactions and events reported in relation to veterinary medicines.
- Lead member state for monitoring the safety of 70 nationally authorised active substances in addition to 56 centrally authorised human medicines as part of its contribution to the work of the Pharmacovigilance Risk Assessment Committee at the EMA.
- The detention of 1,610,295 dosage units of fake and other illegal medicines (2019: 1,018,678). Products detained included sedatives, erectile dysfunction medicines, analgesics and anabolic steroids.
- The processing of 8,043 individual enforcement cases (2019: 6,167). Additionally, three prosecutions were initiated relating to the unauthorised supply of anabolic steroids.
- Undertaking 79 good manufacturing practice (GMP) inspections at manufacturing sites producing human and veterinary medicines, and active substances across Ireland (2019:110). The 2020 compliance programme also included inspections of five tissue establishments, four blood establishments and two organ procurement organisations/transplant centres.
- The review of nine new applications to conduct clinical investigations of medical devices in Ireland with six amendments to ongoing investigations.
- The receipt and assessment of 1,668 medical device vigilance reports. There were 1,120 market surveillance cases undertaken during the year.
- Evaluation of 300 surveillance cases as part of the work programme to monitor the safety and quality of cosmetic products.
Dr Lorraine Nolan, Chief Executive of the HPRA, emphasised the enormous global impact of COVID-19 which necessitated an almost immediate response from scientists and regulators alike to protect and benefit public health.
“The COVID-19 pandemic affected every facet of life here in Ireland and around the world in 2020. Unfortunately, we are all too well aware of the awful effects and devastation caused by COVID-19, but we have equally seen extraordinary and inspirational efforts of frontline healthcare workers to care for those suffering from this terrible disease.”
“As the scale of the impact of the pandemic became clear, we also witnessed a direct and almost instant response from the global scientific community. This culminated in the authorisation of the first COVID-19 vaccines only one year after the identification a completely new virus. This was a remarkable achievement by all involved facilitated by the speed and agility of the global medicines regulatory system. The HPRA was an active participant in that response, both through our work at the EMA and via our contribution to international efforts to co-ordinate and streamline regulatory processes and decision-making.”
“At a national level throughout 2020, we provided expert regulatory support and input in respect of COVID-19 to colleagues across the broader health system, in addition to delivering engagement and communication with healthcare professionals and members of the public. Arising from this collaborative approach, and an increased focus on the key contribution of regulators, I believe there is now a greater understanding and recognition of the HPRA’s role as it relates to medicines, medical devices and other health products in protecting and enhancing public health. It is also worth noting that a similarly integrated partnership response significantly aided us in mitigating against potential disruption to the supply of medicines resulting from Brexit.”
“I am very proud of what the HPRA has achieved in 2020 with colleagues demonstrating extraordinary commitment during this unprecedented period. While continuing to deliver on our core day-to-day activities, we quickly focused on ensuring an appropriate regulatory response to advance and progress the availability of medicines, devices and other health products. This response, adaptive and agile where necessary, has continued during 2021 and has seen the HPRA contribute significantly to the national public health effort during these most challenging of times,” Dr Nolan concluded.
In response to the COVID-19 pandemic, key contributions from the HPRA included:
- Active engagement in the assessment of COVID-19 vaccines and therapeutics at the EMA’s committee for human medicines (CHMP) and its COVID-19 EMA pandemic task force (COVID-EFT).
- Participated in COVID-19 planning with the Department of Health, the HSE and the National Immunisation Office (NIO) through participation in the National Public Health Emergency Team (NPHET).
- Worked in partnership with the Department of Health and the HSE to minimise and proactively address any risks posed to the ongoing supply of medicines to Irish patients.
- Collaborated with the Department of Health and the Office of National Research Ethics Committee to support expedited regulatory review for COVID-19 related health research.
- Actively contributing and developing newly established COVID-19 safety monitoring activities, at both national and European level.
- Participating in the development of a procedure for remote assessment/distance inspection of manufacturers and distributors, in order to permit continued oversight during the COVID-19 pandemic.
The full report is available to download in both English and Irish on the HPRA website.
For Further Information:
Káno Communications Tel: (01) 679 8600
Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438