MHRA

Question 1

Describe the structure of the MHRA
Interaction we have with the inspectorate group and DMRC

Answer 1

Interaction we have with the inspectorate group and DMRC
Who is our Local Inspector - Callum
Inspection Action groups
Recently been re-structed to include three new centres
Science, Research and Innovation.
Healthcare, Quality and Access
Safety and Surveillance
Inspectorate Team – now known as the compliance team – Team 1 GCP,GLP and GPvP and Team 2 – GDP and GMP

Divisions:
IES: Inspection Enforcement and Standards
Inspectorate and process licensing
GMP, GDP, GCP, GLP
Process licensing (MIA, WDA, API registration, Broker registration, GMP/GDP/GLP certs)
Enforcement
Borderline products, IAG and Reg advice
DMRC
Licensing: assess and approve MAs and CTAs
Vigilance and Risk Management: protects public health, post-marketing surveys, Yellow Card scheme
Medical Devices: oversees Notified Bodies, support
Innovation (Advisory)