Letters Drug regulation data

UK drug regulator destroys all evidence after 15 years

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d4203 (Published 05 July 2011) Cite this as: BMJ 2011;343:d4203
  1. Peter C Gøtzsche, professor and director1
  1. 1Nordic Cochrane Centre, Rigshospitalet, DK-2100 Copenhagen Ø, Denmark
  1. pcg{at}cochrane.dk

Jørgensen and I recently gained access to clinical study reports and trial protocols of placebo controlled trials at the European Medicines Agency (EMA).1 Some drugs, however, have not been approved centrally, and in such cases the EMA advises contacting the relevant national drug agencies.

For the antidepressant drug fluoxetine, the United Kingdom acts as Reference Member State according to the Mutual Recognition …

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