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Regulatory Focus™ > News Articles > 2022 > 3 > Euro Roundup: EMA plans new bodies to manage tasks created by extended mandate

Euro Roundup: EMA plans new bodies to manage tasks created by extended mandate

Posted 03 March 2022 | By Nick Paul Taylor 

Euro Roundup: EMA plans new bodies to manage tasks created by extended mandate

New authority created by EU legislation means the European Medicines Agency (EMA) is poised to create several new bodies and formalize existing groups to manage crisis preparedness regarding medicinal products and medical devices.
 
Through the legislation, EU authorities have made permanent some structures and processes EMA put in place to manage the COVID-19 pandemic and given the agency responsibility for certain new tasks.
 
EMA now must establish an Executive Steering Group on Shortages and Safety of Medicinal Products, referred to in the legislation as the Medicines Shortages Steering Group (MSSG). The new group will establish lists of critical medicinal products and provide advice on actions needed to safeguard their quality, safety, efficacy and availability with a view to ensuring “a robust response to major events” and coordinating urgent actions within the EU.
 
The Emergency Task Force (ETF) is set to start operations in mid-April. The ETF will offer scientific advice on developing products for use in a public health emergency, review data, share recommendations on the use of unauthorized medicines, and coordinate independent vaccine effectiveness and safety trials. EMA’s management board plans to consider the composition and rules of procedure of the ETF and MSSG this month.
 
ETF and MSSG are part of a series of milestones planned for the coming weeks and months. EMA also expects to update the role of the EU Single Point of Contact (SPOC) network, the system it and national competent authorities use to exchange information on shortages. SPOC will support the MSSG and “provide recommendations on all matters relating to monitoring and management of shortages and availability issues.”
 
EMA is also preparing to provide companies with guidance on the SPOC network, update its plan for emerging health threats, and establish a list of the main groups of medicines used in emergency care, surgery and intensive care. A workshop is planned for 1 April to explain the plans and timeline.
 
One change happened immediately. On 1 March, the European Commission’s Joint Research Centre (JRC) transferred responsibility for expert panels on medical devices and in vitro diagnostic medical devices to EMA. DG Health and Food Safety (DG SANTE) entrusted JRC with creating the 12 panels as part of the implementation of the new medtech regulations.
 
“It is expected that EMA’s extended mandate will lead to a more integrated, synergistic and coherent approach to the management of availability of medicinal products, medical devices and in vitro diagnostic medical devices at Union level, and of the scientific panels for medical devices, thus improving public health protection for the entire Union,” DG SANTE wrote.
 
EMA Notice, More
 
EFPIA backs Commission’s caution about the timing of animal testing alternatives
 
EFPIA has welcomed the European Commission’s position that it is impossible to predict when it will be possible to replace animal tests with scientifically valid alternatives. The Commission made the comment in response to the European Parliament’s push to accelerate the elimination of animal testing.
 
Last year, the Parliament passed a resolution on plans to speed up the transition away from the use of animals in research and other contexts. The resolution called for the creation of an EU-wide action plan to phase out animal testing “as soon as scientifically possible and without lowering the level of protection for human health and the environment.”
 
In a response published last month, the Commission welcomed the objective of the resolution while cautioning that “although the science behind alternatives is no doubt progressing, it is not possible to predict when scientifically valid methods will become available that can replace particular animal procedures.”
 
EFPIA weighed in this week, stating it supports the Commission’s position on the uncertainty about when new tests will be available and describing progress to date. While noting that computer simulations and other technologies “may lead to a significant reduction of the number of animals actually used,” EFPIA said “most of these methods are not yet able to fully replicate or extrapolate the conclusion of simple models to the complexity and reactions of a living organism.”
 
EFPIA Notice, EU Documents
 
MHRA adds details of HTA tool to ILAP guidance
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Innovative Licensing and Access Pathway (ILAP) with information about a health technology assessment (HTA) access tool.
 
MHRA is pitching the tool to “promote understanding of the market access approaches that will optimize the route to patient access.” Delivered by the National Institute for Health and Care Excellence’s Office for Market Access and groups in Scotland and Wales, the tool is intended to “provide a joined-up view from system stakeholders” in the three countries that make up Great Britain.
 
Topics covered by the tool include establishing where a new technology may fit in the care pathway to help understand its value proposition, the implications of introducing the technology into the National Health Service and high-level HTA challenges. NICE Scientific Advice will continue to handle all in-depth technical questions.
 
MHRA sees the fee-supported, not-for-profit tool as being “most suitable for products that may involve complex HTA and commercial challenges, radical changes to an established care pathway, and significant changes to service delivery, infrastructure, training and workforce.”
 
MHRA Guidance
 
EDQM makes ‘major changes’ to CEP application forms to enable data transfer
 
The European Directorate for the Quality of Medicines (EDQM) has updated the application forms for Certificate of Suitability (CEP) submissions to facilitate the transfer of data in its new IT tools.
 
Major changes include recommending the inclusion of additional information such as the unique identifiers ORG_ID and LOC_ID, linked to data in EMA’s SPOR Organisation Management Services. EDQM also requested that GPS coordinates for manufacturing sites are aligned with the internationally recognized WGS 84 system using latitude and longitude.
 
The directorate also updated the tables to gather information on the marketed medicinal products and list of approved Active Substance Master Files/Drug Master Files to “better take into account a substance’s commercialisation history and quality assessments already performed.”
 
The implementation date for the new forms is 1 April.
 
EDQM Notice
 
In a first for the EU, CHMP recommends a T cell receptor therapy for approval
 
EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Immunocore’s Kimmtrak for approval in the treatment of uveal melanoma.
 
If Kimmtrak (tebentafusp) is approved, it will become the first T cell receptor (TCR) therapy to be made available commercially in Europe. The drug is bispecific protein made of a soluble TCR fused to an anti-CD3 immune-effector function. Immunocore won approval in the US early this year.
 
EMA Notice, More

 

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