Just in case you missed some of this week’s news, here are the highlights:
- MHRA published on 1 September 2020 guidance for industry and organisations to follow after the end of the transition period.
From 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.
Transition from the EU allows the UK to offer fully independent regulatory decisions for both devices and pharmaceuticals, both nationally and in joint work with other international regulators.
Stakeholders need to get ready for new rules from 1 January 2021.
This guidance covers the following topics:
- Clinical trials
- Devices
- Licensing
- Importing and exporting (for those of you who read the previous post on PQG this is old news already)
- IT systems
- Pharmacovigilance (updated today with the new guidance ‘Guidance on QPPV including PSMFs)
- Paediatrics
- EMA has published today the meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August – 3 September 2020.
- For those who chose to work late on a Friday, there is still time to provide feedback as part of the public consultation launched by EMA on joint network strategy to 2025. Use this link to access the questionnaire.
The draft strategy details how the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
It outlines six priority areas for the network:
- the availability and accessibility of medicines;
- data analytics, digital tools and digital transformation;
- innovation;
- antimicrobial resistance and other emerging health threats;
- supply chain challenges; and
- the sustainability of the network and operational excellence.