Last update: May 08th 2017
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

Campaigns - Regulatory issues

December 23th 2015

A PRIME example of how EMA is pushing for accelerated market approvals, but at what cost for patients?

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 Draft Reflection paper on a proposal to enhance early dialogue to facilitate accelerated assessment of priority medicines (PRIME)
In this joint response, we highlight concerns with current attempts to weaken marketing authorisation requirements in the EU, most notably through the EMA’s adaptive pathways project. The PRIME scheme appears to be a complementary move to entrench the provision of confidential, customised advice to pharmaceutical companies in the regulatory system for expedited approval and coverage of new, expensive medicines which as evidence suggests will rarely bring therapeutic advance but often safety concerns. Click below to read this joint response. 

ngojointresponse_emaconsultationonprimescheme_4.pdf (883492)

Latest Campaigns

ISDB - International Society of Drug bullettins

Contact details:
President: president@isdbweb.org
Webmaster: maria.font@ulss20.verona.it

© 2017