Last update: September 06th 2016
August 31th 2016

EMA’s report on adaptive pathways: little data...

A joint press release issued by ISDB, MiEF and Nordic Cochrane Centre regarding the recently published report on EMA's controversial "adaptive pathways" pilot project. The report includes no new factual data, with no information shared about the drug's indications, type...

December 23th 2015

A PRIME example of how EMA is pushing for...

Joint response of Health Action International (HAI), International Society of Drug Bulletins (ISDB), Mario Negri Institute for Pharmacological Research, Medicines in Europe Forum (MiEF), Nordic Cochrane Centre and Wemos to the European Medicines Agency (EMA) public consultation on the...

October 16th 2015

"Adaptive licensing" or "adaptive pathways":...

Joint briefing paper from Health Action International (HAI), The International Society of Drug Bulletins (ISDB), The Medicines in Europe Forum (MiEF), The Mario Negri Institute for Pharmacological Research, The Nordic Cochrane Centre and WEMOS.

"Adaptive pathways"...

March 20th 2015

European Directive on trade secrets: the JURI...

Joint open Letter to the members of the JURI Committee from the Corporate Europe Observatory (CEO), The Medicines in Europe Forum (MiEF) and The International Society of Drug Bulletins (ISDB) calling on the members of the JURI Committee to ensure, through additional and more ambitious...

for members only

Press Release - EMA & other regulatory issues

August 31th 2016

EMA’s report on adaptive pathways: little data and much ado about nothing

A joint press release issued by ISDB, MiEF and Nordic Cochrane Centre regarding the recently published report on EMA's controversial "adaptive pathways" pilot project. The report includes no new factual data, with no information shared about the drug's indications, type of clinical trial data to be submitted or which patient representatives were consulted. In the absence of any real information the pilot is clearly a failure and should be retracted. If “commercial sensitivities” prevent detailed reporting to the public, it is doubly a failure. No fundamental shift to regulation should be based on such secrecy. 

Click below to read this press release.

31082016_emaadaptivepathways_press_release.pdf (111433)

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