Category - Regulatory Affairs

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Compassionate use

What is compassionate use? The term ‘compassionate use’ refers to special programmes set up to make unauthorised medicines available to patients. In particular, this may be a way of...

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Falsified medicines

A falsified medicine is a fake that passes itself off as a real, authorised medicine but contains poor quality or falsified ingredients, no ingredients or in the wrong dose...

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Clinical Trial Approval in Europe

To obtain clinical trial approval, a Clinical Trial Application must be submitted to regulatory bodies and a Research Ethics Committee who review the protocol and gives a positive or...

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Marketing Authorisation Applications

The medicines development process' ultimate goal is an approval for marketing the new medicinal product – a Marketing Authorisation. This should be an integral part of all steps throughout...

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Good Practice – GxP

GxP is an abbreviation for generic good practice, which refers to the series of laws, regulations, and guidance that govern various areas of the research, development, testing, manufacturing, and...

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