MHRA makes a promotion

Mark Birse becomes group manager, Inspections GMP/GDP

Mark Birse has been appointed as the UK Medicines and Healthcare products Regulatory Agency’s Group Manager, Inspections (Good Manufacturing Practice (GMP)/Good Distribution Practice (GDP)) following the retirement of Bryan Wright retirement at the end of March.

Birse is a chemistry graduate with an MSc in pharmaceutical sciences and he joined the MHRA in 2002. He was previously one of the MHRA’s GMP Operations Managers and was based at the Welwyn Garden City office.

Prior to this, Birse worked in the pharmaceutical industry for over 10 years in a variety of roles including production support and quality assurance and he is also eligible to be named as a Qualified Person under Directive 2001/83/EC.

In his new role, Birse will be based at the MHRA’s London head office.

You may also like

Regulatory

MHRA approves beremagene geperpavec gene therapy gel for DEB from birth

The MHRA has approved beremagene geperpavec (Vyjuvek), a topical gene therapy gel for wounds in patients with dystrophic epidermolysis bullosa (DEB), for use from birth onwards
Regulatory

MHRA opens Northern Ireland hub in Belfast to bring regulatory expertise closer to local life sciences sector

The new hub, hosted by Invest Northern Ireland in Belfast, will offer local healthcare and life sciences stakeholders direct in-person access to MHRA technical experts on topics including innovation pathways, clinical investigations and regulatory support throughout the product development pipeline
You need to be a subscriber to read this article.
Click here to find out more.
Regulatory

MC EXCLUSIVE: MHRA on a mission to redefine UK gene therapy

The UK's medicines regulator is seeking industry input on a landmark overhaul of gene therapy medicinal product definitions — the first substantive update in more than two decades — as synthetic mRNA and CRISPR-based technologies outpace the legal framework designed to govern them
Regulatory

MHRA launches consultation to modernise UK gene therapy medicinal product definitions

The UK regulator is seeking industry feedback on proposed updates to the legal classification of GTMPs, as advances in synthetic biology and gene editing outpace definitions set more than a decade ago
Packaging

Amarox recalls sertraline batch after citalopram blister strips found inside sealed cartons

The MHRA has issued a class two recall of one batch of Amarox's sertraline 100 mg film-coated tablets following a secondary packaging error that resulted in citalopram 40 mg blister strips being included in sealed cartons
Regulatory

MHRA report shows agency met targets and closed year in financial surplus

The UK government agency has reported meeting or exceeding every statutory performance target in the 2025/26 financial year, closing in financial surplus while advancing clinical trials reform and AI regulation
Regulatory

MHRA gives guidance to phase out animal testing

The UK regulatory body is aiming to replace animal usage in science by backing developers using non-animal methods and offering early data reviews, with PETA saying innovation "must be adopted or we will be left in the dust"
Subscribe now