Euro Roundup: EMA project supports non-commercial ATMP developers

RoundupsRoundups | 06 October 2022 |  By 

The European Medicines Agency (EMA) has set up a pilot program to provide “enhanced support” to help guide academic and non-profit developers of advanced therapy medicinal products (ATMPs) through the regulatory process.
EMA established the pilot after observing that non-profit academic developers are a “major contributor” to the development of ATMPs such as cell, gene and tissue therapies, but “experience has shown that navigating regulatory requirements can be challenging.”
Participants in the pilot program will receive support from EMA in areas such as best practice principles for manufacturing and planning clinical development that meets regulatory standards.  Participants will benefit from regulatory flexibilities and development support measures, such as fee reductions and waivers.
EMA will not introduce new regulatory tools through the pilot. However, the agency will assess whether further support or regulatory tools can be offered on an ongoing basis to increase the number of ATMPs that reach European patients. EMA also hopes to identify better ways to interact with and support academic developers of ATMPs.
The agency, which will “closely monitor” the progress of the pilot, expects to have initial results in three to four years.
The first participant has already enrolled in the program. EMA will provide extra support to Hospital Clínic de Barcelona as it develops ARI-0001, an autologous, second-generation anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. ARI-0001is in Phase 2 development and authorized in Spain under the “hospital exemption” approval pathway.
EMA Notice
Britain extends use of European Commission reliance pathway to stop post-Brexit access delays
Great Britain has extended the European Commission Decision Reliance Procedure by 12 months to cut “the risk of companies deprioritizing” the market and thereby delaying access to new medicines.
The government established the procedure, which applies to England, Scotland and Wales, in light of the risk that it would take longer for medicines to reach patients once European Union approvals stopped granting access to Great Britain. Under the procedure, companies that have received EMA approval can benefit from a shorter review from the Medicines and Healthcare products Regulatory Agency (MHRA).
Originally, MHRA intended to use the procedure for two years from 1 January 2021. However, applicants will now have access to the pathway for a further year, extending the deadline to the end of 2023, to give MHRA time to “develop proposals for a new international reliance framework.”
MHRA is already part of Project Orbis, a US-led initiative that enables concurrent submission and review of oncology products in multiple markets, and the Access Consortium, which brings together regulators in markets that would typically be lower priorities than the US and EU, namely the UK, Australia, Canada, Singapore and Switzerland.
MHRA Notice
Amid mounting financial pressures, Ireland’s HPRA seeks feedback on 9% fee increase
Ireland’s Health Products Regulatory Authority (HPRA) has proposed a general fee increase of 9%, as it  expects its costs to “increase significantly” next year because of pay rises, the energy crisis and the return of more staff to the office.
HPRA has consistently reported major challenges in its funding proposals in recent years, citing Brexit, the pandemic and the implementation of new clinical trial, medical device and veterinary regulations as factors that are affecting its costs and income. The authority again references those factors in its budget planning for 2023 but they are now joined by, and in some cases secondary to, other pressures.
“In 2023, it is expected that costs will increase significantly due to pay awards, the energy crisis and related inflation, increased onsite activity, the return of staff to the office on a hybrid basis for a full year. Implementing the hybrid model will continue to bring additional costs to both IT and facilities,” HPRA wrote.
HPRA said the workload of its device department has “increased significantly” and it expects COVID-19 to continue consuming resources. As such, staff numbers are forecast to grow and, when combined with pay increases, significantly add to payroll costs. HPRA will not apply the proposed increase to clinical trial and medical device fees. HPRA will review its medical device fees next year as “the full impact of the new legislation is understood.”
HPRA Consultation
Swissmedic finds compliance deviations at 70% of inspected device authorized representatives
The Swiss Agency for Therapeutic Products (Swissmedic) has found regulatory nonconformities at 14 of the 20 authorized representatives it inspected to understand compliance with the new medical device requirements.
Because Switzerland is excluded from the European market surveillance system for medical devices, Swissmedic-authorized representatives of foreign manufacturers must perform vigilance duties and supply the authorities with data and documents about product safety and performance. Swissmedic inspected 20 authorized representatives between March and May 2022 to see if they are meeting the responsibilities.
The inspections identified concerns with the scope and content of the contracts with foreign manufacturers and with responsibility for reporting serious incidents to Swissmedic. The agency gave the authorized representatives the chance to fix the problems, notably through contract changes, and is monitoring the corrective actions.
Swissmedic Report
MHRA appoints first medical device Approved Body since Brexit
MHRA has made DEKRA Certification a UK Approved Body to certify medical devices. The appointment, the first since the UK separated from the EU, sees DEKRA join three other bodies that are authorized to certify devices in the territory.
BSI Assurance UK, SGS United Kingdom and UL International all completed the process before Brexit. DEKRA is the first organization to complete the new designation process that all bodies need to go through to certify medical devices in the UK. Manufacturers of most devices need to obtain certification from a body such as DEKRA to sell products in England, Scotland and Wales.
The certification could be the first in a series of appointments. Another six organizations are already in the assessment process, according to MHRA, and “several” others are preparing to file their initial applications.
MHRA Notice
MedTech Europe sounds alarm that the AI Act will create ‘regulatory uncertainty’
MedTech Europe and other trade groups have raised concerns that the Artificial Intelligence Act could create regulatory uncertainty that limits access to safe, high-quality products.
The concerns center on the alignment between the AI Act and the existing New Legislative Framework (NLF), a cross-industry set of market surveillance and conformity assessment measures. Because the AI Act modifies the NLF, the trade groups fear it could cause “regulatory distortion and misapplication of baseline requirements for manufacturers.”
MedTech Europe and its cosignatories support the incorporation of NLF concepts into the AI Act but want EU authorities to ensure consistency and alignment between the two frameworks. Otherwise, the AI Act could cause “overregulation and misalignment” that stops products from coming to market.
MedTech Europe


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