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

Publication of and access to clinical-trial data – UPDATE
There is more than one way to extend data exclusivity
Personalised Medicine – challenges of authorisation and reimbursement
Health technology assessments and pharmaceutical pricing
Publication and access to clinical-trial data
Paediatric extensions to SPCs
The 'sunset clause' for marketing authorisations
Lobbying in Poland
Why do we need data protection policies?
Clinical Trials
What different classifications apply to pharmaceuticals
Regulatory bodies
How long do marketing authorisations last
Security marketing authorisation
ongoing obligations
Third party access
challenges to regulation
Orphan drugs
Advanced therapy medicines
Advanced therapy medicines
Early access to new medicines