News Category: Regulatory news
The HPRA today published its 2021 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 the second year of the COVID-19 pandemic.
During 2021, the HPRA’s key activities included:
- 542 new human medicines were authorised during 2021 (2020: 424).
- The HPRA was among the top 10 contributors at EU level for lead assessment of centrally authorised human medicines and scientific advice. It served as rapporteur for 11 assessments and as co-rapporteur for 10 assessments (2020: 12 and six applications, respectively) under the centrally authorised route for human medicines approvals. Additionally, it coordinated 82 EMA scientific advice and coordinated 82 EMA scientific advice procedures for human medicines (2020: 119).
- At year-end, there were 1,914 authorised veterinary medicines on the Irish market (2020: 1,880).
- The HPRA was the leading national competent authority in the EU for outgoing work related to new veterinary medicines authorisation.
- 107 applications were issued for clinical trials of human medicines (2020: 73).
- The HPRA was EU rapporteur for the monitoring of any safety signals for 56 centrally authorised human medicines (2020: 56).
- The HPRA received 25,622 suspected adverse reaction reports for human medicines (2020: 7,752), of which 17,946 were associated with the use of COVID-19 vaccines. The HPRA also received 439 reports of suspected adverse reactions associated with the use of veterinary medicines (2020: 391).
- 124 medicines were recalled, consisting of 117 human medicines and 7 veterinary medicines (2020: 85, 72 and 13, respectively).
- The HPRA conducted 87 good manufacturing practice (GMP) inspections at sites that produce human medicines or active substances (2020: 63). There were nine GMP inspections of manufacturers producing veterinary medicines (2020: 16).
- 5,726 export and free sale certificates issued – 1,244 certificates for medicines and 4,482 free sale certificates for medical devices (2020: 3,539, 1,019 and 2,250, respectively).
- 294 medical device economic operators registered by the HPRA on the national database (2020: 183).
- 882 market surveillance cases were undertaken in respect of medical devices (2020: 1,120). The HPRA received and assessed 1,855 medical device vigilance reports (2020: 1,668).
- 1,604,589 dosage units of falsified and other illegal medicines were detained (2020: 1,610,295). Products detained included sedatives, erectile dysfunction medicines, analgesics and anabolic steroids.
- 248 reactive surveillance cases were initiated as part of the work programme to monitor the safety and quality of cosmetic products (2020: 300).
Dr Lorraine Nolan, Chief Executive of the HPRA said that as expected, the pandemic response remained a priority for the organisation in 2021, while continuing to deliver on its core day-to-day activities.
“The continual authorisation of safe and effective vaccines and therapeutics as the year progressed provided new approaches and a renewed hope in our fight to protect public health. By the end of 2021, an additional four vaccines had been authorised for use in Europe in addition to the first authorisation granted in late 2020.
“As a result of the overwhelming success of the national vaccination campaign, supported by many stakeholders across the broader health system, including the HPRA, we have been able to decouple the relationship between SARS-CoV-2 infection and disease severity. As vaccination rates increased, severe disease, ICU admissions and deaths due to COVID steadily declined throughout the year despite initial concerns associated with the emergence of new variants.
“Our experts participated at NPHET, NIAC and the High-Level Task Force on COVID-19 Vaccination, providing regulatory updates and data to help inform and support both the pandemic response decision-making and the subsequent public health advice. The HPRA also contributed significantly on many fronts to the pandemic response effort at European level, including permanent representation on the EMA’s Emergency Expert Task Force, which was a leading contributor in Europe to the evaluation and review of vaccines.
“The initial oversight of the development of safe and effective vaccines was only part of the process. The regulatory system also needed an incredible level of agility and foresight to ensure the continued safety and trust in vaccines during the extraordinary national, regional and global vaccination campaigns with billions of doses administered by the end of 2021. At a national level, our HPRA safety monitoring team worked tirelessly to ensure the continued safety of all approved COVID-19 vaccines and therapeutics demonstrating a huge level of commitment and diligence in processing over 18,000 national reports of suspected side effects associated with COVID-19 vaccines.
“The year in review was also significant in that the HPRA launched and commenced delivery of its new Strategic Plan for 2021 to 2025, details of which are outlined in this annual report. At the heart of the Strategic Plan are the themes of partnerships and collaboration, responsive and adaptive regulation, and support for innovation. Reflecting on 2021, I believe all of these important elements were clearly evident, not just in the context of the HPRA’s response to the pandemic, but across all its various work programmes.
“I would like to thank all my colleagues who, throughout 2021, worked tirelessly and maintained their absolute commitment to both public and animal health protection during a period of immense challenge,” Dr Nolan concluded.
The full report is available to download in both English and Irish.
For further information:
Káno Communications Tel: (01) 679 8600
Siobhán Molloy / Kathryn Moley (086) 817 5066 / (086) 733 4438