Europe -
Application of EU Clinical Trial Regulation Delayed to 2019

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

"Due to these delays, the EU Clinical Trial Regulation will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday.

The agency says it will provide an update at the next meeting of the Management Board in October 2017, following closer work with its IT service provider to ensure corrective measures are implemented...

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Suisse -
L’ONG Public Eye s’attaque aux prix des médicaments

Réduire le prix très élevé de certains médicaments en Suisse, c’est l’objectif de la campagne lancée mardi par l’ONG Public Eye. Elle appelle le gouvernement à recourir à des licences obligatoires pour contourner les brevets des groupes pharmaceutiques. Une démarche qui ne plaît pas aux pharmas. L'instauration de licences obligatoires en Suisse autoriserait la production ou l'importation de versions génériques pour des médicaments brevetés, même sans l'accord de leur détenteur. Ce procédé permettrait la mise sur le marché d'une version moins onéreuse, dans le but d'alléger les coûts de la...

International -
Critical Condition: Inside Pfizer’s Drug Supply Problem

How a much-touted acquisition by America’s biggest pharmaceutical company helped turn the country’s chronic drug shortage into a full-blown crisis. This February Ruth Landau, an obstetric anesthesiologist at ­Columbia University Medical Center in New York City, was making rounds when she got a disturbing call from one of the hospital’s pharmacists. The center was due to run out of bupivacaine, a local anesthetic used in virtually every baby delivery. Fast-acting and predictable, the numbing agent has long been the drug of choice for supporting childbirth, administered as an epidural for women...

Europe -
New EDQM guideline "How to read a CEP"

EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP). This document is intended to give Industry and Competent Authorities clarification on the meaning of the statements laid down on the CEPs. Access the new guideline “How to read a CEP”

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