Useful resources & links

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Regulatory agencies

European Medicines Agency (EMA)

EU Notified Bodies (NB) - for medical devices

United States of America Food and Drug Administration (US FDA) - for human pharmaceuticals

US FDA - for medical devices including in-vitro diagnostics (IVD) and companion diagnostics (CDx)

United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)

Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

USA - Comparison of selected potential benefits for pharmaceutical developers

Breakthrough therapy designation (US) for human pharmaceutical drugs

Fast track designation (US) for human pharmaceutical drugs

Accelerated approval (US) for human pharmaceutical drugs

Priority review (US) for human pharmaceutical drugs

Breakthrough devices program (US)

Safer technologies program (STeP) for medical devices (US)

Priority review program for medical devices (US)

Has been superseded by the breakthrough devices program

Expedited access pathway (EAP) for medical devices (US)

Has been superseded by the breakthrough devices program