Medicines and Procedures in UK Law
-
Fast-Tracking Approval of Medicines – UK Publishes Detailed Guidance on its New International Recognition Procedure
On 30 August 2023, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) published detailed guidance on its recently announced new International Reliance Procedure (“IRP”) (see our ...... ... The IRP will apply from 1 January 2024 and will replace and significantly expand on existing EU reliance procedures to apply to authorizations from 7 key international regulators. As such, the IRP will allow the MHRA to take into account the expertise and ... ...
-
UK Life Sciences and Healthcare Newsletter: Regulatory Updates
MHRA updates post-transition guidance Since 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) has been updating various aspects of the regulatory regime for medicines...... ... Since 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) has been updating various ... MHRA’s decentralised or mutual recognition procedures which would enable MAs approved in EU member states (or Iceland, ... ...
-
Brexit And Life Sciences Update
... ... authorisations using either the centralised or decentralised procedures. CE marking for medical devices will continue to be used and recognised ... -stated with 823 applications for commercial clinical trials of medicines having been submitted in the UK in 2017 ... Proposals in the report ... ...
-
UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last 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 ...... ... The UK currently has reliance procedures in place for medicines that are centrally authorized by the European Commission or authorized in the EU through decentralized and mutual recognition ... ...
-
UK publishes "no deal" guidance for medicines and medical devices
The UK government has published several guidance documents on how to prepare for Brexit in the event of a "no deal" scenario (i.e. if the UK and EU do not agree a future trade deal and the proposed...... ... The UK would no longer be part of the EU centralised, mutual recognition or decentralised procedures for authorising medicines. Existing medicines that received a marketing authorisation for the UK via the mutual recognition or decentralised routes ... ...
-
New MHRA Guidance On Pharma Product Assessment Post-Brexit
...The Medicines and Healthcare products Regulatory Agency (MHRA) ... has published a ... licensing procedures, including: ... procedures to prioritise access to new medicines that will ... ...
-
Brexit and COVID-19: Changes to the Regulation of Medicines
The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines. On 16 October 2020, the UK...... ... This follows a set of guidance issued on 1 September 2020. The October guidance provides greater clarity on the procedures for supplies to and from Northern Ireland ... The guidance published so far includes the following: ... Clinical Trials ... Guidance for clinical ... ...
-
Regulating Medical Devices Post Brexit
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices ......The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on ... sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021 ... This ... ...
-
New UK International Recognition Framework for Medicines
We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whe...... ... This procedure will operate in parallel to the MHRAs current national procedures, including the shortened 150-day timetable, offering applicants a range of authorisation routes depending on the status in other countries and type ... ...
-
Spotlight On MRNA ' Regulation Of MRNA Vaccines And Therapies
... ... therapies is that they are regulated as human medicines. There are ... some specific considerations for each type of therapy but ... However, from 1 January 2021, changes to the UK ... procedures took effect and now there are several different pathways ... to securing a ... ...
See all results