Health Products Regulatory Authority 2018 annual report shows 376 new human medicines were approved during 2018

The Health Products Regulatory Authority (HPRA) published its 2018 annual report recently, 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 the health product areas it regulates, with a core focus of protecting public and animal health, according to the Authority. The report also highlights how the national regulator responded “effectively and rapidly to significant external developments impacting the wider health sector”. 

During 2018, the HPRA’s activities included:

The authorisation of 376 new human medicines during 2018 following an assessment of their safety, quality and effectiveness. 

There were 118 new marketing authorisations issued for veterinary medicines, contributing to the record figure of approximately 1,800 veterinary medicines now authorised for the Irish market. 

100 clinical trials of human medicine products were approved to commence in 2018 (2017:96). 

The HPRA received 10,398 adverse reaction reports in relation to human medicines in 2018. In respect of veterinary medicines, there were 394 suspected adverse reactions and events reported during the year. The HPRA said it welcomed 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, it added.

Dr Lorraine Nolan, HPRA

There were a total of 196 human medicine recalls and six recalls relating to veterinary medicines.

The HPRA initiated 4,532 enforcement cases (2017:3,866) — 619,213 dosage units of illegal medicines were detained during the year (2017:984,915). The illegal products detained included sedatives (36 per cent), erectile dysfunction medicines (18 per cent) and anabolic steroids (16 per cent).

2,358 medical device vigilance reports were notified and assessed during 2018 (2017:2,339). 

104 good manufacturing practice (GMP) inspections were undertaken at manufacturing sites producing human medicines and active substances. Twelve GMP inspections were conducted at sites that manufacture/test veterinary medicines.

The HPRA’s active participation at EU level during 2018 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 53 nationally authorised active substances, in addition to 46 centrally-authorised medicines.   

Serving as rapporteur for five applications and as co-rapporteur for 11 applications under the centralised authorisation route for new human medicines. 

The HPRA also served as rapporteur or co-rapporteur under the centralised route for three veterinary medicines.

In addition, the HPRA provided experts to participate in five joint assessments of medical device notified bodies in other European countries.  

We continue to be busy at EU level, working closely with regulatory counterparts through a wide range of committees and working groups at the European medicines agencies, the heads of medicines agencies and the competent authorities for medical devices

According to Dr Lorraine Nolan, Chief Executive of the HPRA, during 2018 all parts of the organisation contributed to the delivery of a sizeable programme of work, both in terms of core regulatory activities and ongoing organisational development. 

There was significant progress across a number of key strategic projects and areas of focus and Dr Nolan said she is confident that these developments will enable the HPRA to continue to deliver on its public health remit. 

“In what was an incredibly busy year, we engaged extensively with stakeholders to focus on our preparedness for Brexit and to help us to effectively manage the potential impact on health product supply and availability. Given the central role of UK regulators within the European network over many years, this has been a difficult and complex task on many levels. 

“We continue to be busy at EU level, working closely with regulatory counterparts through a wide range of committees and working groups at the European medicines agencies, the heads of medicines agencies and the competent authorities for medical devices. At a global level, as part of our work with the International Coalition of Medicines Regulatory Authority (ICMRA), the HPRA joined with a number of authorities, both to review and enhance existing regulatory approaches and to identify new regulatory tools to ensure safe and timely access to innovative health products. We were also proud to host the 18th International Conference of Drug Regulatory Authorities (ICDRA) on behalf of the World Health Organisation (WHO). The conference brought together WHO member states to strengthen collaboration and develop international consensus on regulatory priorities,” she added.

“Once again, 2018 saw us continue 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 use these products. During the year, working with our partners in An Garda Síochána and Revenue’s Customs Service, we detained almost 620,000 dosage units coming into Ireland. We continue to urge members of the public not to take risks with their health and to remember that the consumption of even very small quantities of these illegal medicines could potentially have very serious consequences.

“In recent years, we witnessed a marked increase in the number of illegal anabolic steroids we were detaining. To raise awareness of the harmful side-effects of using these products, we launched a public information campaign entitled ‘Zero Gains’, targeting young men in light of the growing evidence of anabolic steroid use to enhance body image. Using new research which showed a lack of awareness of the health risks associated with steroid use, the campaign incorporated social and digital media, outdoor and in-gym adverts, in addition to traditional print and broadcast media channels to get the message across.” 

Looking forward, according to Dr Nolan, the HPRA is keen to continue addressing the challenges of and adapting to the ever-evolving environment in which they operate. “We will continue to prioritise and advance regulation to best serve the Irish public and to further enhance how we work as an organisation. In particular, we must continually keep pace with the rapidly-evolving pharmaceutical, medical device and cosmetic sectors so as to protect and enhance the health of the people and animals benefiting from the breadth of products we regulate.”