In October 2014, the European Medicines Agency (EMA) promulgated its policy 0070 on the release of regulatory data acquired and held in the course of its regulatory function. At the time, some of us advised caution in accepting the policy at face value, although we recognised the great contribution that the policy and the EMA’s attitude […]
European regulatory agencies frequently inform doctors and pharmacists about their activities, paying particular attention to pharmacovigilance. The Italian Medicines Agency (AIFA) started a new information feed on 3 April 2012: “Pills from the world.” Every morning a news item is posted online, but analysis of some of the posted items is thought provoking. AIFA declares […]
It’s hard to imagine a restaurant without a menu, a sheet where the fare is listed, where the ingredients are explained, and limitations are clearly labelled (“not for people with gluten intolerance,” for example). How would we know what to order without a menu? But when it comes to selecting documents on the safety and […]
The European Medicines Agency (EMA) has now released the final version of its policy on the prospective release of clinical reports of trials, which are submitted by sponsors to support marketing authorisation applications (MAAs). The agency has said that it will—at a future date—determine how to release individual participant data (IPD). Scope The policy—to become effective from 1 January […]
Yesterday’s announcement that the EMA Management Board may have adopted a less obstructive policy to releasing clinical trial data comes hard on the heels of widespread coverage (see here, here, here, and here) and protests (by the EU Ombudsman, us, us again, Trudo Lemmens, the ISDB/AIM/ Nordic Cochrane Centre/ Medicines in Europe Forum, German IQWiG, […]
Tom Jefferson and Peter Doshi are two of the guys who battled for four years to access clinical study reports on antivirals for influenza for their Cochrane review. Here they muse on the possible arrival of look-but-don’t-touch research. Trudo Lemmens is a law professor. He has been working on the promotion of data transparency for […]
How does a doctor obtain informed consent for H1N1 immunisation consistent with General Medical Council guidance? The Department of Health’s guidance does not provide sufficient information for this. This is our attempt to rectify this omission, providing information required for informed consent consistent with good professional practice. We outline the main principles of General Medical […]
England’s chief medical officer Sir Liam Donaldson can sound gloomy and pessimistic but he sounded very upbeat in this week’s swine flu update, saying: “We may have got a lucky break in how the virus has behaved at the start of our flu season and we may be able to get the vaccine out there […]
In March 2017 Health Canada released a discussion paper promising a new era in transparency. The agency committed itself to proactively releasing clinical trial data submitted by drug companies, similar to what the European Medicines Agency (EMA) is already doing and, again like the EMA, to processing applications for the same information for drugs already […]
Health Canada has been talking about improving the transparency of information around pharmaceutical drugs for years. And for years the drug regulator has failed to back up that talk with commitment and action. The lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. Unless a drug’s full safety and effectiveness […]