A list of select Brexit updates compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group.
September 2018 Update
- August 2018 Update
- May 2018 Update
- April 2018 Update
- A 21 month transition period (March 29th to end of 2020) is agreed for BREXIT implementation.
- What level of MHRA participation in EMA will be agreed ?
- ‘limited’ ; ‘close alignment’ ?
- The EU have stated that the UK’s ‘red lines’ on leaving the single market and customs union would ‘inevitably’ limit the alignment
- Still more work to be done, including on activities of notified bodies (devices)
- EC posts minutes and presentations from technical expert seminar (8th March) on pharmaceutical matters following BREXIT
- 80 experts from 27 states. Meeting to inform experts about the ‘overall state of play’, the preparedness measures taken and collect expert perspectives on these measures and identify and discuss gaps / action plan.
- Comments on the ‘wait and see’ approach by MAHs… need to act swiftly “considering as a baseline for preparedness the withdrawal date of 30th march 2019” (not the transition period)
- Another technical seminar ‘may be convened’ Q2’18
- UK Health and Social Care Committee life science recommendations
- Main recommendation is that the UK and EU should aim to secure the ‘closest possible regulatory alignment’ – e.g. ‘close’ associate membership of the EMA
- March 2018 Update
- February 2018 Update
- January 2018 Update
Regulations, Guidelines & Other Documents
A select list of recently updated regulations, guidelines and other documents compiled by the ISPE Regulatory Quality Harmonization Committee (RQHC)’s Europe-Middle East-Africa Regional Focus Group
October 2018 Update