News Category: Regulatory news
Over 1 million falsified or counterfeit medicines detained in 12 months
The HPRA today published its annual report of key activities and performance highlights for 2015. The report details a successful year that has seen the HPRA complete its ambitious strategic plan (2011-2015) while prioritising its goal to protect public and animal health through the effective regulation of health products.
During 2015, key elements and highlights included;
- The approval of 108 clinical trials (80: 2014) for commencement in Ireland relevant to human medicines. The key clinical research areas continue to be cancer and blood disorders.
- The HPRA individually assessed and followed up 2,810 (2,884: 2014) adverse reaction reports in relation to human medicines in 2015. In addition, some 437 (300: 2014) suspected adverse reactions and events involving veterinary medicines were reported to and reviewed by the HPRA.
- It opened 107 (116: 2014) compliance cases under its market surveillance programme for cosmetic products. These included 90 cosmetic products deemed to be non-compliant with EU regulations. The breaches were mainly related to labelling, prohibited substances, contamination and/or unsupported efficacy claims.
- Over 2,126 (2,113: 2014) vigilance reports for medical devices were received. Each individual case was assessed to review risks and impact for the Irish market as well as to initiate follow-up actions as required.
- The HPRA opened 3,677 (3,703: 2014) enforcement cases and detained over 1 million (1,136,494) dosage units of medicines (730,056: 2014). Sedative products accounted for almost two-thirds (64%) of all detentions. Erectile dysfunction products and illegal cosmetic products accounted for 9% and 6% of detentions, respectively. Other categories detained included anabolic steroids as well as slimming and pain relief products.
- There were a total of 344 (260: 2014) national and foreign site inspections and audits carried out during the year to monitor industry compliance with standards and regulations.
- There were 113 human medicine and three veterinary medicine recalls in 2015.
- The HPRA assessed and issued 15,691 (13,205: 2014) variations to marketing authorisations for human medicines. New human medicine product authorisations increased in 2015 to 806 (615: 2014).
- It authorised 83 (126: 2014) new product applications and 1,431 (1,502: 2014) variations to existing authorisations for veterinary medicines during 2015.
- Activities at EU level included:
- The HPRA was allocated as lead assessor (rapporteur) or joint lead assessor (co-rapporteur) for 12 new marketing authorisation applications (human medicines) by the EMA.
- It acted as lead Member State for the monitoring and management of safety signals for 54 nationally authorised and 27 centrally authorised active substances for human medicines.
- The HPRA was rapporteur for one paediatric Article 45 procedure and nine procedures relating to Paediatric Investigational Plans. These are important initiatives from a public health viewpoint as they increase the availability of medicines specifically indicated for use in children.
According to Lorraine Nolan, Chief Executive, 2015 was a highly productive year where the HPRA as an organisation continued to clearly focus on its commitment to protect consumer and animal health through a risk-based regulatory approach.
“Under the guidance of my predecessor, Pat O’Mahony and my colleague Ms Rita Purcell, who served as acting interim Chief Executive, all departments completed significant levels of work outputs across an expansive market that incorporates many thousands of different health products. Our regulatory remit and responsibility continues to grow and evolve as new national and European legislation across the health product arena develops to further enhance and safeguard public health. This requires our expert staff to continually respond to an innovative and progressive health product industry as well as to the regulatory environment. Our new Strategic Plan 2016-2020 has been developed to further enhance how we work as an organisation so that we can continually keep pace with the rapidly evolving pharmaceutical, medical device and cosmetic sectors while protecting the safety of the people and animals benefiting from health products,” Ms Nolan says.
Annual Report 2015 / Tuarascáil Bhliantúil 2015
For further information:
Weber Shandwick PR: (01) 679 8600
Siobhan Molloy / Barry Ryan: 086 817 5066 / 085 728 7326