The European Patients’ Academy (EUPATI) guidance document on patient involvement in regulatory processes aims to support the integration of patient involvement across the entire process.
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 making a promising but not yet authorised medicine available to patients who: cannot currently be treated satisfactorily with authorised medicines, have a disease for which no…Read more
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 and pose a major threat to public health and patient safety.
Medicines regulation ensures that only sufficiently safe, effective and high quality medicines can be marketed.
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 negative opinion. This is to ascertain that the research is conducted in compliance with European regulations, directives and guidelines defined by the International Conference on Harmonisation. This is an international quality standard that describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and ethics committees.
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 the life-cycle of the medicinal product. A Marketing Authorisation Application contains information on quality, and non-clinical and clinical studies.
A patients involved case report on the Duchenne Parent Project collaborating with academia and industry to find a cure/treatment for Duchenne Muscular Dystrophy.
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 distribution of medicines. GxP rules and guidelines ensure that all aspects of the medicines development process are conducted according to the best methods for safety, efficacy, and quality.
Medicines regulation is the basis for ensuring that only medicines of a high quality are marketed. In Europe, the European Commission proposes high-level legislation in the form of regulations and directives. The European Medicines Agency (EMA) coordinates the development of new and revised EU scientific guidelines in working groups/parties.
A medicine can be marketed in the European Union (EU) until the company has obtained a Marketing Authorisation (MA) for that medicine from the relevant regulatory authority. MAs are granted for medicines that are proved to be safe, effective and of high quality.