Who is the European Medicines Agency (EMA) - ANSWER-an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal
... [Show More] products. The primary reason for establishing EMA was to harmonise the work being done by the individual
regulatory bodies in Europe.
Relevance of EMA in EU - ANSWER-founded in 1995, working across the EU to protect
human and animal health by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based informa tion on medicines
Mission of EMA - ANSWER--Facilitate dev and access to medicines
-Evaluate applications for marketing authorisation
-Monitor safety of meds
-Provide info on human and vet meds to professionals and patients
New Approach (EU) - ANSWER-The basic concept is including Essential Requirements for safety and performance in the core legal text and publishing the technical specifications in harmonised standards.
Other def: A innovative regulatory technique tha includes mandatory Essential requirements, conformity assessment procedures and CE marking.
1990s, New Approach (impact on MDs) - ANSWER-EU regulations relating to medical devices' safety and performance were harmonised in the ____(date) _, following the _____ _____ legislative principles.
AIMDD (# and date) - ANSWER-Council Directive 90/385/ EEC, 20 June 1990
MDD (# and date) - ANSWER-Council Directive 93/42/EEC, 14 June 1993
IVDD (# and date) - ANSWER-Directive 98/79/EC of the European Parliament and of the Council, 27 October 1998
key historic developments influencing today's EU healthcare regulations - ETHICS - ANSWER-the Nuremberg Code, was drafted in 1947.
The Helsinki Declaration of 1964 further developed
the Nuremburg Code's principles, and tied them to
the Declaration of Geneva (1948), an internationally
acknowledged statement of physicians' ethical responsibilities.
medicinal product advertising and promotion (#) - ANSWER-EU Directive 2001/83/EC [Show Less]