The European Commission has proposed specific measures to increase the supervision and monitoring of the use of antimicrobial medicinal products (or “antimicrobials”), with the aim to counter the spread of antimicrobial resistance (“AMR”). At the same time, the measures are also aimed at promoting and incentivizing the development of new
Continue Reading EU Pharma Legislation Review Series: AMR and Transferable Exclusivity Vouchers
As part of its policy goal of promoting innovation, the Commission’s proposed Regulation creates the concept of a “regulatory sandbox.” If the concept survives the legislative process, the sandbox will be a structured, regulated and time-limited environment in which innovative technologies, products, services or approaches might be tested in a
Continue Reading EU Pharma Legislation Review Series: The Regulatory Sandbox – A Safe Space for Innovators to Grow
On 26 April 2023, the European Commission published its long awaited proposal to revise the EU pharmaceutical legislation. The proposal includes a new draft Regulation, which will repeal Regulation (EC) No 726/2004, the Orphan Medicines Regulation 141/2000 and the Paediatric Regulation 1901/2006.
As expected, the draft Regulation significantly shakes
Continue Reading EU Pharma Legislation Review Series: Orphan Medicines
The European Commission (“Commission”) intends to change the rules on regulatory data protection (“RDP”) of medicinal products. The Commission stated in its Impact Assessment for the revised pharmaceutical legislation that it wants to strike a balance between “providing attractive incentives for innovation and supporting timely patient access to medicinal
Continue Reading EU Pharma Legislation Review Series: Regulatory Data ProtectionLast week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals
Continue Reading UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.
Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.Continue Reading New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD
The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before). Low notified body capacity is a key contributing factor for the transition delays.Continue Reading European Commission Announces Intention to Introduce Three-Year Extension to the MDR Transition Period
In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe. But what will this mean for companies who sell in-vitro-diagnostic medical devices (“IVDs”) in the UK?
Following the UK’s exit from the EU, the IVDR will not become effective within Great Britain (i.e., England, Scotland and Wales), but it will apply to Northern Ireland. Companies operating in both the EU/Northern Ireland and Great Britain will therefore need to be aware of the different obligations applicable to IVDs between these jurisdictions.
IVDR Background
The IVDR will replace the existing EU IVD Directive (the “IVDD”), but will not change the fundamental principles of how IVDs are regulated. IVDs will be still be subject to a system of self-certification, notified body assessment (in certain instances) and CE marking. Most notably, under the current system, ~90% of IVDs are self-assessed for conformity and self-certified by the IVD’s manufacturer. By contrast under the IVDR, the new classification rules mean that this will be flipped to require ~90% of IVDs to be subject to notified body assessment. This creates practical issues for manufacturers, since there are currently only seven notified bodies who are authorized to conduct conformity assessments under the IVDR.Continue Reading What do companies supplying IVDs to the UK market need to know about the IVDR?