Regulatory Issues Concerning Behavioral and Psychological Symptoms of Dementia in Europe

Abstract

In 1995, a new European system for the authorization of medicinal products went into effect. After 10 years of cooperation between National Registration Authorities at the European Union (EU) level and 4 years of negotiation, in June 1993 the Council of the EU adopted three directives and a regulation that together form the legal basis of the current system. The European Medicines Evaluation Agency (EMEA) was established on July 22, 1993, and London was chosen as its coordinating center, housing the Committee for Proprietary Medicinal Products (CPMP), which is the body that advises the European Licensing Authority (European Commission). The EMEA has the opportunity to harness the expertise and resources of member states and their ability to oversee local implementation.

Brief checklist for non‐cognitive symptoms of dementia

“…BPSD may be helpful in the differential diagnosis of dementia. For example, behavioural and psychological symptoms of vascular dementia are similar to those of Alzheimer's disease [22–24], aggressive behaviour and visual hallucinations and delusions are prominent in Lewy body disease [25,26], and personality and behavioural changes precede and remain prominent during the course of fronto‐temporal dementia [27–29]. BPSD may be useful in the early diagnosis of dementia.…”