Regulatory compliance

The life sciences sector is characterised by its high level of regulation.  At least a basic understanding of this complex regulatory environment is essential for any business operating the sector, and this section aims to provide an overview of the regulatory regime for both medicines and medical devices.

Regulatory Compliance
Largest single Biomedical Laboratory in Europe opened by Queen
Largest single Biomedical Laboratory in Europe opened by Queen
CE mark approval for medical devices – an overview
FDA and EMA Clusters
Public Contracts Regulations 2015 – In with the new, but not quite out with the old...
Licensing of Medicines: Manufacturers, wholesale dealers and brokers
Bribery Act - Germany gets ready for stricter criminal laws
New active substances and global marketing authorisations
Monitoring the safety of healthcare products in the UK: the Yellow Card Scheme
General court confirms orphan drug data exclusivity
Borderline products: food or medicine?
FSA transparency initiative in Germany
Adaptive licensing: a model approach?
Health claim
EU Commission regulates post-authorisation efficacy studies
Post-marketing surveillance of medicines: the Black Triangle scheme
Personalised Medicine – challenges of authorisation and reimbursement
There is more than one way to extend data exclusivity
Paediatric extensions to SPCs
Health technology assessments and pharmaceutical pricing
Why do we need data protection policies?
The 'sunset clause' for marketing authorisations
What different classifications apply to pharmaceuticals
Clinical Trials
Regulatory bodies
Security marketing authorisation
How long do marketing authorisations last
ongoing obligations
challenges to regulation
Advanced therapy medicines
Orphan drugs
Early access to new medicines
Advanced therapy medicines
Biologicals and biosimilars
public funds
Medical devices