Use of real-world evidence in postmarketing medicines regulation in the European Union: a systematic assessment of European Medicines Agency referrals 2013–2017
Objectives To assess the use, and evaluate the usefulness, of non-interventional studies and routinely collected healthcare data in postmarketing assessments conducted by the European Medicines Agency (EMA).Design We reviewed and systematically assessed all referrals to the EMA made due to safety or...
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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e028133.full |
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