Overview: Medicines & Medical Devices (15 mins)
This course has four sections which cover the development lifecycle of a pharmaceutical or healthcare technology product.
- Taking forward my/our idea
- What are the environments where my/our idea will develop
- How can I / we reduce risk
- How can I / we find partners and/or networking
There are different regulatory practices across the world for developing medicines but they generally develop through a multi-phase series of non-clinical then clinical trials before gaining approval in areas of the world where medicines will be marketed. A medicines development process chart downloadable - ABPI, online - EUPATI
The average number of years to get a licence for a medicine from initial development is just over 12 years with clinical trial phases 1-3 starting at 7 years. Clinical trials will need different forms of review including ethical approval (Institutional Review Boards in the US, Ethical Committees in the EU, Reviewing Clinical Trials)
You may need partners and the development process is expensive. If you're starting with nothing, you can connect with academia and/or patient or research organizations and your national agency (NRA) to find a route to market.
Devices in Europe are developed to approved manufacturing standards before an approved CE mark is provided and displayed on the device. In the USA, the FDA also require full clinical trials before approval is given.
Healthcare apps may or may not require regulatory approval. In the UK, the MHRA have produced a useful interactive guide to help decide whether your app is regulated or not. In the US, the FDA have provided guidance for low risk apps.
Common abbreviations in this course:
EMA: European Medicines Agency (European regulator)
FDA: Food and Drug Administration Agency (US regulator)
MHRA: Medicines and Healthcare Products Regulatory Agency (UK regulator)
ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (International committee to harmonise standards)
EUPATI: European Patients Academy
NRA: National Regulatory Agency
EU: European Union
US: United States of America