As the European Medicines Agency (EMA) announces final consultations on its clinical trial data policy will begin at the start of May, we take a look at the issues surrounding trial transparency in Europe.
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.
The EU industry commissioner has said the scale of pharmaceutical counterfeiting “exceeded our worst fears” and the EPHA has weighed into the debate on the development of the draft directive.
Environmental representatives have emerged triumphant in the latest
round of negotiations over the finer bones of contention of the
European REACH chemicals legislation, due to come in force in April
next year.
European parliamentarians have come up with a long list of measures
that the EU needs to take to combat counterfeit drugs, yet track
and trace technologies were noticeably absent from their calls for
action.
EU ministers yesterday agreed on a compromise version of the
controversial new chemicals law, REACH, however environment groups
have condemned the latest changes as a further watering down of the
law in favour of industry.
A European parliament vote on the REACH chemicals legislation last
week struck a balance between health, the environment and industry
after months of intense debate.
The rapporteur trying to finesse the controversial REACH
legislation through the European Parliament, Guido Sacconi, has
formulated a compromise that aims to alleviate fears that the
regulations could pose a heavy financial burden...
