LNB News 09/05/2025
Document Information
Issue Date: 09 May 2025
Published Date: 09 May 2025
Jurisdiction(s): England, Northern Ireland, Scotland and Wales
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on the International Council for Harmonisation (ICH) M13B guideline concerning bioequivalence assessment for immediate-release solid oral dosage forms. The draft guideline, developed by the ICH Expert Working Group, outlines scientific and technical requirements for study design and data analysis in bioequivalence assessment. This represents the second guideline in the series since MHRA became a full ICH member in May 2022. The consultation closes at 11:59pm on 31 July 2025.
To continue reading this news article, as well as thousands of others like it, sign in with ³ÉÈËÓ°Òô or register for a free trial
EXISTING USER? SIGN IN CONTINUE READING GET A QUOTE
To read the full news article, register for a free Lexis+ trial
**Trials are provided to all ³ÉÈËÓ°Òô content, excluding Practice Compliance, Practice Management and Risk and Compliance, subscription packages are tailored to your specific needs. To discuss trialling these ³ÉÈËÓ°Òô services please email customer service via our online form. Free trials are only available to individuals based in the UK, Ireland and selected UK overseas territories and Caribbean countries. We may terminate this trial at any time or decide not to give a trial, for any reason. Trial includes one question to LexisAsk during the length of the trial.
* denotes a required field
Scotland—the process for applying for sequestrationSequestration in Scotland is the legal process by which an insolvent debtor’s estate is gathered in, realised and then distributed among their creditors by a trustee appointed for that purpose. The process requires that a formal award of
If planning permission imposes restrictions on a licensed premises opening hours, once operational can the personal licence holder apply for a Temporary Events Notice (TEN) to open for longer hours than those permitted in the planning permission?To use any property for a licensable activity both
Early leavers—preservationFORTHCOMING DEVELOPMENT: Section 10 of the Finance Act 2022 will increase the normal minimum pension age (NMPA) from 55 to 57 on 6 April 2028 (save for members of the firefighters, police and armed forces public service pension schemes).The Finance Act 2022 will also give
Brussels I (recast)—domicile (Arts 4 and 63) [Archived]ARCHIVED: This Practice Note has been archived and is not maintained.This Practice Note considers the general rule set out in Article 4 of Regulation (EU) 1215/2012, Brussels I (recast) when determining the relevance of a defendant’s domicile to
0330 161 1234