Treatment Updates

In care related news this month, the European Medicines Agency releases a video explaining the new EU pharmacovigilance legislation, the European Commission attempts to revamp how medical trials in Europe are run, and a review of the recalled vaccine Preflucel is completed, following reported suspected allergic side effects


New EMA video on pharmacovigilance


The European Medicines Agency (EMA) has launched a video to introduce and explain the new EU pharmacovigilance legislation. The legislation (consisting of an EU Directive and a Regulation) entered into force in July this year. It aims to improve European-wide mechanisms for monitoring the safety and benefit-risk of medicines. More information can be found on this EMA page.


In connection with this, the Agency also launched a public consultation in July on the changes to product information (leaflets etc.) stemming from the new rules. They require certain information to be added to the summary of medicinal product characteristics and to package leaflets, for example a black symbol to denote medicines that are under additional monitoring for safety issues and a statement encouraging people to report suspected side effects to their national reporting system. The EMA public consultation aimed to present these proposals to stakeholders and ascertain their opinions on how best to implement them. The consultation closed on the 17th of August.


European Commission proposal on new rules for clinical trials in Europe


In July the European Commission proposed to revamp the rules regarding medicine trials taking place in the EU. If adopted, the proposal for a new Regulation on Clinical Trials on Medicinal Products for Human Use will replace the current Clinical Trials Directive of 2001, with the overall aim of speeding up and simplifying the authorisation and reporting procedures for clinical trials, while maintaining the highest standards of patient safety and data reliability.


The main proposals of the draft Regulation are a new authorisation procedure for clinical trials, allowing for a fast and thorough assessment of applications; simplified trial reporting procedures to spare different researchers from submitting identical information; more transparency on recruitment of clinical trial participants and trail results; and the possibility for the Commission to conduct controls to make sure the rules are being properly enforced.


The legislative proposal will now be discussed by the European Parliament and Council and, if agreed upon, is expected to come into effect in 2016. Press release Question & answer info doc


Review of recalled flu vaccine following reports of suspected allergic side effects


On the 19th of July the European Medicines Agency (EMA) completed a review of Preflucel, a vaccine which had been withdrawn from EU markets following reported suspected side effects including hypersensitivity (allergic) reactions. The Agency’s Committee for Medicinal Products for Human Use (CHMP) said that the likely cause has now been identified, and specified a number of measures to be integrated into the production process to rectify it.


Preflucel is a vaccine used to prevent seasonal influenza (flu) in adults, including influenza A and B. In October 2011 the manufacturers of Preflucel, Baxter, voluntarily recalled certain batches following reports of suspected cases of anaphylactic (severe allergic) reactions, influenza-like symptoms and eye reactions. When no immediate cause could be identified at the manufacturing sites, all batches on European markets were recalled and the matter referred to the EMA.


If the European Commission rules in favour of EMA’s conclusions, the company will need to formally apply to implement the measures recommended, and the vaccine, once reproduced, will undergo further quality testing before being re-released on the European market. Frequent post-marketing studies are also envisaged. Press release

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