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
CE mark approval for medical devices – an overview
FDA and EMA Clusters
New active substances and global marketing authorisations
Adaptive licensing: a model approach?
Health claim
EU Commission regulates post-authorisation efficacy studies
Personalised Medicine – challenges of authorisation and reimbursement
Paediatric extensions to SPCs
Health technology assessments and pharmaceutical pricing
Why do we need data protection policies?
The 'sunset clause' for marketing authorisations