Life Sciences Seasonal Update

1. The Competent Authorities for Medical Devices (CAMD) publishes statement re the transition to the Medical Devices Regulation (MDR) 

The CAMD has published a statement regarding the transition to the MDR following discussions at its plenary meeting on 3 June.
 
In summary, the CAMD: 

• Recognises the urgent challenges relating to sector capacity and readiness ahead of May 2024 (notified body certificates issued in accordance with the previous directives will become void from this date) which, if left unaddressed, may affect the supply of critical and innovate devices to the EU market.
• Outlines their commitment to work with EU colleagues and relevant stakeholders to find solutions to these challenges and to prevent supply disruptions.
• Agrees that solutions should focus on getting manufacturers on the road to compliance and should not generally involve a reinterpretation of MDR requirements or derogations issued by national competent authorities.
• Proposes that work on finding solutions to these challenges is progressed urgently. 

The Q&A document published by the CAMD is to provide guidance in the area of certificates for free sale and considers how certificates should be processed or generated for "legacy" and MDR-compliant devices. The Q&A document highlights where certificates can be issued in the context of Article 60(1) of the MDR and where the use of national provisions may be required.

The EMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications.
 
Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualisation.
 
The pilot project is open to applicants or MAHs that are about to submit marketing authorisation applications or post-authorisation applications. If selected, they will include raw data already as part of their submissions. The pilot is expected to last up to two years and will include approximately ten regulatory procedures submitted to EMA from September 2022. The pilot will fully comply with data protection legislation requirements.

The regulation allows veterinary medicines authorised before 28 January 2022 to continue to be placed on the market until 29 January 2027, even if the labelling and package leaflet are not in compliance with Regulation 2019/6.

The flexibility in updating the packaging and labelling of products does not apply to veterinary antibiotics, which must conform to any new requirements that are needed to address the challenge of antimicrobial resistance.

At its July 2022 meeting, EMA’s Paediatric Committee (PDCO) elected Brian Aylward as its new chair for a three-year mandate.
 
Dr Aylward has been actively involved in various PDCO activities since 2010 when he was appointed as alternate for Ireland before becoming a committee member in 2013. He has been chair of the Formulations Working Group of the PDCO since 2014.
 
Before joining the Health Products Regulatory Authority (HPRA) in Ireland in 2008, he practiced as an anaesthesiologist and intensive care medicine physician. Prior to his appointment to the PDCO, he was a member of the Clinical Trials Facilitation Group at the Heads of Medicines Agencies (HMA).
 
’’The PDCO has a pivotal role in advising decision-making bodies, both within and outside EMA, and other stakeholders about advances in paediatric medicine. I look forward to working with all these stakeholders to help ensure that effective, safe, and age-appropriate medicines are available for use in children and adolescents.” said Dr Aylward.

6. The European Medicines Agency (EMA), the European Commission and the Heads of Medicines Agencies (HMA) has published the 2022-2026 workplan re accelerating clinical trials
 
The 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT in the EU) has been published. It launched in January 2022 and aims at transforming how clinical trials are initiated, designed and run, as well as developing the EU as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. The key focus areas are innovation in clinical trials, robust methodologies and collaboration across stakeholders.

7. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12- 15 September 

• 12 new medicines recommended for approval
• 11 recommendations on extensions of therapeutic indication
• 2 applications for marketing authorisations were withdrawn
• COVID-19 updates
• Safety update – medicines containing high dose nomegestrol or chlormadinone should be used at the lowest effective dose and for the shortest duration, only when other interventions are not appropriate

Read the highlights in full.

Irish Updates 

1. The HPRA has published a Guide to Performance Studies Conducted in Ireland 

The Guide has been published by the HPRA to provide an overview of legislation and key concepts relevant to performance studies involving in vitro diagnostic medical devices (IVDs) for performance studies sponsors (e.g. manufacturers, academic groups, clinical research organisations) who wish to conduct performance studies involving IVDs in Ireland.

2. The Department of Health has issued a publication on Regulation (EC) No. 1169/2011 (the Food Information to Consumers (FIC) Regulation) 

The FIC Regulation sets out the requirements for the information provided on food labelling and provides for a high level of consumer protection.
 
The Irish Government is developing a policy position on the European Commission’s food labelling package. This is being developed by a cross Government group headed by Department of Health working closely with the Department of Agriculture, Food & the Marine, the Department of the Environment, Climate and Communications and the Department of Enterprise, Trade and Employment, as well as relevant agencies under the remit of all four Departments.
 
Read the booklet in full, published for stakeholders following a virtual event held in May 2022.

The HPRA have issued an alert regarding serious health risks associated with the unauthorised substance Melanotan 2, often used as a self-tanning aid.
 
The HPRA is responsible for prosecuting cases where it considers there is a significant risk to public health or three are persistent non-compliances. Melanotan 2 is unauthorised by the HPRA and the HPRA are taking enforcement action in respect of same, including successful prosecutions.

Risks of using Melanotan 2. 

The World Health organisation (WHO) and the International Telecommunication Union (ITU) have jointly developed a global standard for accessibility of telehealth services. This standard provides a list of technical requirements that telehealth platforms must have to ensure accessible telehealth service provision.
 
The development of these standards also aligns with the Irish Government’s Digital Ireland Framework which was launched in February this year to help to maximise the wellbeing of Irish people and their businesses. The government is committed to ensure these benefits are achieved by ensuring widespread access and use of inclusive digital public services, with a target of 90% of services to be consumed online by 2030.

5. Applications to the Health Products Regulation Authority open for designation of EU reference laboratories in the field of in vitro diagnostic medical devices  

The EU Commission launched a formal call for applications for designation of EU reference laboratories in the field of in vitro diagnostic medical devices under the IVDR. The purpose of this call is to invite Member States to submit applications for laboratories in their jurisdictions in view of their possible designation as EU reference laboratories. The European Commission may only designate the EU reference laboratories for which a Member State or the European Commission’s Joint Research Centre has submitted an application for designation. The closing date for notifying the HPRA of an intention to apply is 30 September 2022, the closing date for applications to be submitted is 5 January 2023.

6. The HPRA has published guidance on updated to the EU Compilation of Union Procedures on Inspections and Exchange of Information 

The EU Compilation of Union Procedures on Inspections and Exchange of Information has been updated and the updates were adopted in September 2021 to come into force at the end of June 2022. These updates have relevant considerations for holders of GMP and GDP authorisations. The updates contain both revised documents as well as new procedures for compliance management and interpretation of Union format for a wholesale distribution authorisation.