On 28 August 2020, the UK Department of Health & Social Care published a consultation on proposed changes to the Human Medicines Regulations 2012 (HMRs) to support the rollout of COVID-19 vaccines.
Continue Reading Consultation on legislative changes to support the rollout of COVID-19 vaccines in the UK
COVID-19
Update: Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs has now been adopted
By Dr Beatriz San Martin & Eftychia Sideri on
Earlier this month, we commented on the European Commission proposal for a Regulation accelerating existing procedures for clinical trials where medicinal products containing or consisting of Genetically Modified Organisms (GMOs) are tested for the development of vaccines and therapies to treat COVID-19. The European Commission had proposed that, during the pandemic and by derogation to the GMO regulatory framework, the requirement of a prior environmental risk assessment or consent by the national competent authorities should not apply. …
Continue Reading Update: Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs has now been adopted
EMA Guidance on fast-tracking the development and approval of treatments and vaccines for COVID-19
On 4 May 2020, the European Medicines Agency (EMA) issued a guidance to support development and regulatory approval for treatments and vaccines for COVID-19 with the involvement of the dedicated EMA Pandemic Task Force (COVID-ETF). It sets out the available regulatory pathways to fast-track assessment of both new or repurposed methods of treating or preventing COVID-19.
Background
This guidance is part of EMA’s efforts to support the development and availability of medicinal products for COVID-19 to address this public health emergency. See also EMA’s guidance on clinical management trials (which we have summarised in a prior Advisory)
This latest guidance is based on the existing and established regulatory procedures to accelerate regulatory review and approval with appropriate adaptations in direct response to COVID-19 pandemic.…
Continue Reading EMA Guidance on fast-tracking the development and approval of treatments and vaccines for COVID-19
EU MDR implementation: new guidance and implications of the deferral
By Jackie Mulryne, Louise Strom & Eftychia Sideri on
As part of our series of blog posts covering the implementation of the EU Medical Devices Regulation (MDR), we comment below on the latest developments, including the deferred application of the MDR and the most recent guidance issued by the European Commission’s medical device coordination group (MDCG).…
Continue Reading EU MDR implementation: new guidance and implications of the deferral
UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients
By Dr Beatriz San Martin & Ewan Townsend on
The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.
Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.