News Category: Regulatory news
The HPRA has published its 2022 annual report, detailing its activities in regulating 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 during the year to new developments, as COVID-19 restrictions were widely relaxed and society reopened.
During 2022, the HPRA’s key activities included:
- 529 new human medicines were authorised (2021: 542).
- 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 10 assessments and as co-rapporteur for eight assessments (2021: 11 and 10 applications, respectively) under the centrally authorised route for human medicines approvals. Additionally, it coordinated 109 EMA scientific advice procedures for human medicines (2021: 82).
- At year-end, there were 1,925 authorised veterinary medicines on the Irish market (2021: 1,914).
- The HPRA was the third leading national competent authority in the EU for outgoing work related to new veterinary medicines authorisation.
- 64 applications were issued for clinical trials of human medicines (2021: 107).
- The HPRA was EU rapporteur for the monitoring of any safety signals for 58 centrally authorised human medicines. (2021: 56).
- The HPRA received 10,918 suspected adverse reaction reports for human medicines (2021: 25,622).
- We processed 4,321 periodic safety update reports (PSURs) for veterinary medicines which included assessment work at both a national and European level.
- 60 medicines were recalled, consisting of 58 human medicines and two veterinary medicines (2021: 124, 117 and seven, respectively).
- The HPRA conducted 114 good manufacturing practice (GMP) inspections at sites that produce human medicines or active substances (2021: 87). There were 10 GMP inspections of manufacturers producing veterinary medicines (2021: nine).
- 6,809 export and free sale certificates issued – 1,448 certificates for medicines and 5,361 free sale certificates for medical devices (2021: 5,726, 1,244 and 4,482, respectively).
- 199 medical device economic operators registered by the HPRA on the national database (2021: 294).
- 516 market surveillance cases were undertaken in respect of medical devices (2021: 882). The HPRA received and assessed 3,935 medical device vigilance reports (2021: 1,855).
- 956,263 dosage units of falsified and other illegal medicines were detained (2022: 1,604,589). Products detained included sedatives, erectile dysfunction medicines, analgesics and anabolic steroids.
Dr Lorraine Nolan, Chief Executive of the HPRA, said 2022 saw significant changes in the legislative landscape, including the implementation of the New Veterinary Regulation, Clinical Trials Regulation, Medical Devices Regulation, and In-Vitro Diagnostics Regulation.
"The HPRA has worked hard in recent years to prepare for the implementation of these new regulations, and this work was maintained as we adjusted to the new regulatory frameworks. We continue to work closely with key stakeholders to ensure the transition is as smooth as possible for all involved. These new legislative frameworks present an opportunity for us to further develop and grow to meet the demands of a changing regulatory environment.
The New Veterinary Regulation modernises the rules for the authorisation and use of veterinary medicines in the EU and it is hoped it will ultimately stimulate the development of innovative veterinary medicines. The Clinical Trials Regulation (CTR) brings with it a streamlining and centralisation of key regulatory procedures relating to clinical trials, including a single submission for applications, as well as simplification of certain reporting requirements. The introduction of the CTR has strengthened the collaboration between the HPRA and the National Research Ethics Committee for Clinical Trials, as we worked together to integrate our systems to support the timely approval of clinical trial applications received under the regulation.
Meanwhile, the introduction of the Medical Devices Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) represents a significant enhancement to how medical devices are regulated in Europe. We as an organisation have undertaken a great deal of work in preparing for the implementation of this new regulatory framework, including the restructuring of our medical devices department and enhancement of resources, skills, and expertise. We commit to continuing these efforts, and to working closely with regulators, policymakers, industry, healthcare professionals, and patients, to support the successful implementation of the MDR and IVDR."
Dr Nolan also thanked the members of the HPRA's Patient Forum for the valuable and progressive work undertaken throughout the year. "The Patient Forum was developed to provide a platform for dialogue and exchange between patients and the HPRA on issues relevant to the regulation of medicines and medical devices, and to give Irish patients a voice in the regulatory process. Facilitating access to the unique breadth of experience and knowledge possessed by patients is invaluable to us as an organisation and will help ensure that we continue to place the patient and patient needs at the heart of everything we do."
Commenting on the ongoing issue of medicines shortages, Dr Nolan highlighted the importance of the work undertaken at national level by the multi-stakeholder medicines shortages framework, which is coordinated by the HPRA.
"Effective management of shortages requires cooperative and coordinated efforts from all key stakeholders. The framework provides a platform through which we can work together to develop and implement long-term strategies to address this complex issue."
Dr Nolan also reflected on the experience of the past three years and the need for this to inform decisions and practices going forward.
"The pandemic demonstrated the speed with which the scientific world is capable of reacting, with numerous treatments developed at a pace never seen before. As the world of science rapidly evolves, in turn so must the way in which we regulate health products. I would like to thank all my colleagues who, throughout 2022, worked tirelessly and remained steadfast in their commitment to both public and animal health," Dr Nolan concluded.
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For further information:
Káno Communications: (01) 679 8600
Siobhán Molloy / Kathryn Moley: (086) 817 5066 / (086) 733 4438