What to Learn More?
- Association of the British Pharmaceutical Industry (ABPI) - represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
- European Medicines Agency (EMEA) - is a decentralised agency of the European Union (EU), located in London. It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU.
- Health Research Authority (HRA) - Established in 2011 the authorities purposes are to protect and promote the interest of patients and the public in health and social care research, coordinate and standardise practices relating to regulation, recognise and establish Research Ethics Committees (RECs), be a member of UK Ethics Committee Authority (UKECA), promote transparency in research and provide approvals for the processing of confidential information relating to patients.
- ICH Website - The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
- Medicines and Healthcare products Regulatory Agency (MHRA) - the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
- Royal College of Nursing (RCN) - is the world’s largest nursing union and professional body. We represent more than 435,000 nurses, student nurses, midwives and health care assistants in the UK and internationally.
- The Clinical Trials Toolkit - provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK.
- US Food & Drug Administration (FDA) - oversees US Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.
Downloadable Directives, Guidelines & Legislation
- Directive 2001/20/EC (European Union Clinical Trial Directive)
- Directive 2005/28/EC (GCP Directive)
- Directive 2007/47/EC (Medical Device Directive)
- Directive 90/385/EEC (Active Implantable Medical Devices Directive)
- Directive 93/42/EEC (Medical Devices Directive)
- Directive 98/79/EEC (In Vitro Diagnostic Medical Devices)
- ICH-GCP E6(R2) Guidelines
- The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
- The Medicines for Human Use (Clinical Trials) Regulations 2004