Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations

Study identification

• EU PAS number:
  EUPAS21337
• Study ID:
  24545
• Official title and acronym:
  Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The evaluation of the public health impact of regulatory interventions is important but there is currently no common methodological approach to guide this evaluation. This systematic review of the literature (Medline and Embase) provides a descriptive overview of the analytical methods used for measuring the impact of pharmacovigilance regulatory actions to safeguard public health.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Actual:01/03/2017

Study start date

Actual:28/04/2017

Data analysis start date

Actual:01/07/2017

Date of final study report

Planned:01/08/2017

Actual:20/12/2017

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable