PubMed | 1 Bundesinstitut For Arzneimittel Und Medizinprodukte, Agenzia Italiana del Farmaco, European Medicines Agency, Bundesinstitut For Arzneimittel Und Medizinprodukte and 2 more.
Type: Journal Article | Journal: Nature reviews. Drug discovery | Year: 2015
Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.
PubMed | 1 European Medicines Agency
Type: Journal Article | Journal: Nature reviews. Drug discovery | Year: 2013
Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.