The EMA Committee for Orphan Medicinal Products (COMP) reviews applications for orphan-medicinal-product designation.
Pharmacovigilance is the practice of detecting, understanding, and preventing adverse events or any other medicine-related problem.
Special considerations are necessary when prescribing medicines in special populations, such as children, the elderly, pregnant and breastfeeding women, and patients with renal (kidney) or hepatic (liver) impairment.
The process of enrolling in clinical trials is carefully regulated, as is the way in which sponsors advertise clinical trials to prospective participants. Patients are screened and must give their informed consent before they can enrol in a trial.
Developing medicines for children is important, but requires special measures to be taken during clinical development in order to shield children from undue risk.
Paediatric medicine development requires careful planning and decision making. Legislation in the EU mandates that paediatric medicine development should occur early in the medicine development process.
The regulations governing paediatric medicine differ between the EU and the US.
Clinical trial results are recorded in a clinical study report (CSR) in a prescribed manner; however, access to the CSR is usually limited. Summarised information from the CSR comes into the public domain via a number of routes.
Life-cycle management activities begin as soon as a medicine receives authorisation from the regulatory authorities. Research on the medicine continues in order to gather additional data on safety and investigate other possible indications that the medicine might treat.
After Phase III of clinical studies, all the information on a medicin is collected and organised in a pre-determiend format (a dossier), which is then submitted to the regulatory authorities. The regulatory authorities then decide whether or not a medicine can be prescribed to patients.