Euro Roundup: MHRA outlines steps to accelerate access to medical products
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a business plan for fiscal year 2024/2025, setting out how it will work to achieve four high-level goals including enabling access to new, safe and effective medical products.MHRA established a three-year corporate plan last year and has updated it with more detail of what the agency wants to achieve in the current fiscal year (1 April 2024 to 31 March 2025). MHRA aims to “improve and optimize regulatory services via new risk-proportionate regulatory pathways including international recognition of other stringent regulators’ decisions to enable access to medical products.”
MHRA wants to eliminate all service backlogs by the end of the financial year and review its international recognition procedure to ensure adherence to statutory timelines in the third quarter. The agency also aims to provide “individual timeframes for applicants, encompassing all pre-submission and licensing activities” and launch a refreshed Innovative Licensing and Access Pathway by the third quarter.
Other objectives relate to the launches of new digital tools. In the fourth quarter, MHRA is planning to deliver the second release of RegulatoryConnect, a tool designed to modernize management systems and support interactions with stakeholders. The agency sees the tool as supporting the optimal performance of licensing procedures. The delivery of the safety signal tool SafetyConnect is due around the same time.
The fourth quarter should see MHRA pilot a single unified gateway for patient, public, and industry inquiries. Ahead of the start date, the agency plans to identify the types of automated solutions that most effectively meet its customers’ needs and improve its internal knowledge hub.
MHRA’s pilot project is part of a broader set of activities intended to further its goal of maintaining public trust through transparency and proactive communication. The other two overarching objectives are to deliver scientific and regulatory excellence through strategic partnerships and become an agency where people flourish alongside a responsive customer service culture.
Press Release, Business Plan
MDCG publishes guidance to clarify what products are regulated under IVDR
The Medical Device Coordination Group (MDCG) has published guidance on the qualification of in vitro diagnostics (IVD), providing general principles and specific points about how products are regulated in the EU.
The EU diagnostic regulation defines IVDs and accessories to IVDs. Products that meet these definitions fall within the scope of the IVD Regulation (IVDR). However, there are gray areas. Existing documents on borderline medical devices and software clear up some uncertainties, but MDCG identified a need for guidance on the qualification of IVDs.
MDCG said the demarcation between IVDR and the Medical Devices Regulation (MDR) is significant because the latter text states it does not apply to IVDs. To draw a line between IVDR and MDR, the group has described the essential characteristics of an IVD and discussed specific qualification topics.
A section on devices incorporating a medical device as an integral part addresses one area of overlap between MDR and IVDR. Integral products have two constituent parts, one IVD and one medical device, which are physically combined into a single object. Examples of integral products include swabs with integrated reagents. In this example, the reagent is an IVD, and the integrated product is regulated under MDR.
Other products can contain an IVD and medical device but are not considered integral. MDGC cited a urine receptacle to which a detachable funnel can be attached as an example of a product with an IVD that is qualified separately.
MDCG Guidance
Implementation of UK voluntary pricing scheme is taking longer than hoped: ABPI
Pharma trade group ABPI said implementation of the new UK voluntary pricing scheme “has taken longer than we would like” and that work to resolve problems is ongoing.
ABPI commented in the first operational reviews it agreed to conduct every 6 months. The 2024 scheme introduced a different level of payment for older and newer branded medicines. Rates for older medicines are set by assessing price changes against a historical “reference price.” ABPI said identifying reference prices has been a “huge and complex exercise” for UK authorities.
The older product approach has also been challenging for companies, ABPI said, “with ongoing delays making it harder to assess the payment rates across their portfolios.” The trade group has heard from companies that “have had to deploy additional resource to check data and report back” to the UK health department.
ABPI said companies had received “the bulk of reference price data” as of September, but the health department was still discussing some areas. Access to the data is enabling companies to start assessing the rates' impact.
“Early reports from companies suggest that the viability of some medicines will be under review,” ABPI said. “After factoring in ‘older medicine’ payment rates, some medicines may no longer be viable to provide to the NHS at their current price. This could, in turn, lead to market withdrawals, less competition, risk supply issues, or lead to price increases to the NHS.”
ABPI Statement
Biosimilar applications to EMA triple
The number of applications for biosimilar products jumped over the first half of the year, with EMA receiving 25 submissions in six months. EMA received eight applications over the first half of 2023.
The figures, which EMA presented at a meeting of its management board, are part of a broader uptick in activity. EMA said applications for new medicines increased by 20% for the second year in a row, and the number of scientific advice and protocol assistance requests increased by 16%. The increase caused the number of advice and assistance requests to exceed 400 over the 6 months.
EMA’s management board also discussed the European medicines agencies network strategy and the handling of declarations of interests by scientific committee members and experts. The board endorsed an updated network strategy, which runs through to 2028 and reflects changes since the original 5-year plan was adopted. EMA will release the strategy for consultation.
Officials are also planning to hold a public consultation about declarations of interest. The board signed off on draft changes intended to bring the policy in line with judgments by the Court of Justice. Public consultation is set to start imminently so that a final revised policy will be ready for adoption by the board in December.
Press Release
Other news:
The European Commission has signed a €20 million ($22 million) agreement with Fabentech to support developing and deploying broad-spectrum therapeutics to combat biological threats to public health. The Commission provided support through its Health Emergency Preparedness and Response Authority (HERA) and the European Investment Bank. The deal is the first of its kind. As part of HERA’s push to mitigate priority health threats, more investments are in the pipeline. Press Release
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