HPRA Publishes 2016 Annual Report

News Category: Regulatory news

Date: 18/09/2017

During 2016, its activities included:

• The authorisation of 637 new human medicines during 2016 (806:2015) while also issuing 14,207 variations to marketing authorisations for human medicines (15,691:2015).
• 108 clinical trials of human medicine products approved to commence in 2016. This is the same number of clinical trials approved in 2015.
• The individual assessment and follow up of 3,264 adverse reaction reports in relation to human medicines in 2016 (2,810:2015). In addition, some 337 suspected adverse reactions and events involving veterinary medicines were reported to and reviewed by the HPRA (435:2015).
• A total of 209 medicine recalls, 201 relating to human medicines (113: 2015) and eight relating to veterinary medicine products (3:2015).
• 126 new marketing authorisation applications for veterinary medicines assessed and 1,341 variations to existing marketing authorisations for these products issued.
• 4,054 enforcement cases were initiated (3,677: 2015) while 673,906 dosage units of illegal medicines were detained during the year (1,136,494: 2015). The illegal products detained included sedatives (40%), anabolic steroids (16%) and erectile dysfunction medicines (14%).
• 2,216 medical device vigilance reports were received and assessed during 2016 (2,126:2015). Surgical devices, orthopaedic devices and infusion devices accounted for 42% of the total vigilance reports. The HPRA also investigated 335 market surveillance cases with the number of medical device cases it assesses on an annual basis having doubled since 2012.
• 471 cosmetic products were sent for laboratory testing with 11% (54 products) found to be non-compliant. Non-compliances included microbial contamination of talcum powders and face paints.
• 94 GMP inspections were conducted of sites manufacturing human and veterinary medicines, and active substances.

Activities at an EU level during 2016 included the following: 

• The HPRA acted as lead in 51 European Medicines Agency (EMA) scientific advice procedures for medicines proposed for the treatment of a broad range of conditions. Areas of focus included medicines to treat respiratory disorders, auto immune inflammatory diseases, cancers and blood disorders, monoclonal antibodies and biosimilar medicines.
• The allocation of five rapporteurships, nine co-rapporteurships and six procedures as peer reviewer by the EMA in the area of human medicines authorisations. These included treatments for respiratory, musculoskeletal, dermatological, gynaecological and orphan diseases. A number of these applications were for biological medicines.
• The management of any safety signals detected in relation to 40 centrally authorised human medicines, serving as EMA rapporteur, in addition to 54 nationally-authorised active substances.
• The allocation of five rapporteurships and six co-rapporteurships by the EMA in respect of veterinary medicines.
• The completion of seven inspections in countries outside of the European Economic Area at the request of the EMA relating to centrally-authorised medicines.
• In addition, the HPRA provided technical, clinical and quality system experts to support six joint assessments of medical device notified bodies in other European countries. It has contributed expert assessors to more EU joint assessments than any other European authority since the scheme was introduced in 2013.

According to Dr Lorraine Nolan, Chief Executive of the HPRA, 2016 was the first year of the organisation’s Strategic Plan 2016-2020. The plan, which provides a roadmap for the future advancement of the HPRA, outlines its commitment to adapting and evolving alongside the rapidly changing pharmaceutical, medical device and cosmetic sectors while ensuring it continues to protect the safety of the people and animals benefiting from health products. 

“During 2016, the HPRA witnessed a number of milestones in our continued development as the national health products regulator. We launched our Innovation Office to support academia and entrepreneurs in the development of novel health products; we carried out our first ever public information campaign which urges members of the public to take medicines safely and we marked the 50th anniversary of the establishment of the National Drugs Advisory Board, the precursor to the HPRA today. The outcomes and achievements during 2016 are evident from the contributions we have made at both national and EU level in protecting public and animal health.”