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Regulatory News | 08 June 2017 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The Austrian Federal Office for Safety in Health Care (BASG) has called on physicians and other healthcare professionals to comply with their obligations to report adverse events. BASG made the request after reviewing the number of adverse event reports it received from the groups last year.
Healthcare professionals used to play a significant role in the reporting of adverse events, but their participation has fallen away in recent years. Last year, the number of reports they submitted rose by 3% but this gain fell well short of offsetting earlier losses. Healthcare staff filed 40% fewer adverse event reports last year than in 2009. That amounts to approximately 350 fewer reports. The number of reports from a certain type of physician fell 27% last year.
BASG responded to the findings by reminding healthcare professionals of their legal obligations to report adverse events. The regulator also reminded healthcare professionals of the system it has deployed to gather adverse event reports, which requires users to provide four pieces of information.
Overall, the number of adverse events reported to Austrian authorities increased by 13% last year. The number of initial reports increased by 9%. The upward trend was driven by an 8% rise in the number of adverse event reports submitted by pharmaceutical companies and a surge in the voluntary involvement of patients.
BASG received 78% more reports from patients in 2016 than the prior year, albeit from a low starting point of 124 submissions. The agency granted patients the ability to report adverse events in 2014 and, according to BASG, awareness of the system among the general public is low.
BASG Notice (German)
A counterfeit pack of Gilead Sciences’ hepatitis C blockbuster Harvoni has entered the legal supply chain in Germany. The German Federal Institute for Drugs and Medical Devices (BfArM) learned of the presence of the counterfeit after a patient informed their pharmacy they had received a fake.
The patient identified the tablets as fakes from their color. Genuine Harvoni tablets are orange. The tablets received by the patient were white. BfArM said all other aspects of the drug and its packaging, including the batch number, tablet form and embossing, matched the features of genuine packs of Harvoni.
Officials are now investigating how the tablets entered the legitimate supply chain and what ingredients they contain. BfArM has told pharmacists and patients dispensing and taking Harvoni to check the color of the tablets and report the discovery of counterfeits.
The emergence of counterfeit Harvoni in Germany follows reports of fakes in other countries. Over the past 18 months, regulators in Israel, Japan and Switzerland have discovered batches of fake Harvoni. The tablets found in Switzerland, like those discovered in Germany, were white. Batches discovered in Japan were more diverse. Some tablets were purple. Others were more oval in shape than the diamond-shaped tablets manufactured by Gilead.
BfArM Statement (German)
EMA has scheduled a meeting to discuss how to improve the treatment of children with mature B cell malignancies such as leukemia and lymphoma. The agency wants to establish how to identify and trial the experimental drugs most likely to have a favorable risk-benefit profile in children.
Officials have identified two broad unmet needs in the patient populations. Among the patients for whom existing drugs are effective, the side effects are severe. The second problem is current drugs fail some patients. EMA thinks drugs being developed to treat B cell malignancies in adults may address these unmet needs, but it is unclear on the best way to bring these treatment options to children.
The meeting will seek to address this question, first by assessing how to identify the drugs most likely to meet the unmet pediatric needs. Beyond this, EMA also wants to evaluate how to trial the drugs in very small patient populations. These trials will either seek to show efficacy in patients with refractory or relapsed cancers or reduce toxicity among patients for whom existing drugs are effective.
EMA Notice, Draft Program
The European Medicines Agency (EMA) is organizing a focus group to discuss the use of field trials to assess the efficacy of veterinary vaccines. EMA created the focus group to consider the need to change its guidance in response to long-standing industry concerns about the value and practicality of running field trials.
Critics of field efficacy trials argue they fail to deliver enough value to applications for approval to justify the difficulty of running them. Problems include too little of the infectious agent circulating in the field to show the protective efficacy of a vaccine. Companies claim this makes it difficult to replicate challenge trials in the field. Improvements to the biosecurity of farms identified for use in field trials has resulted in declines in the incidence of disease, too, further complicating the use of the model to generate efficacy data.
These concerns were voiced at an event EMA held with the Heads of Medicines Agencies in 2015. EMA followed up on the event with the publication of an action plan that identified a rethink of field efficacy trials as one of the top priorities for the vaccine industry. This led EMA to make the creation of a focus group one of its most pressing objectives.
The focus group is due to meet later this month. EMA has invited certain organizations to attend the two-day event. The agency aims to identify specific challenges faced by the industry, assess the value field trial efficacy data brings to dossiers and consider alternative sources of evidence of the anticipated protective effect of vaccines under field conditions. EMA also plans to recommend practical measures on how it and the industry can clear barriers to the use of alternative sources of information. The group will also make recommendations on the need for field efficacy trials.
Currently, there is a gap between regulatory and industry perceptions of the value of field efficacy trials and the flexibility provided by current legislation. The directive on field trials provides scope for vaccine developers to rely on other sources of efficacy data provided they can justify the decision. EMA guidance on the topic reiterates this point. However, the perception in the industry is that the failure to include field efficacy data in a dossier results in applications the regulator will decline to validate and to delays.
If the industry gets its way, the guidance could be changed. EMA has already gathered details of the changes desired by the industry. The hope is EMA will consent to limiting the routine use of field trials to the generation of safety data. Companies would only run field efficacy trials to gather data to support certain specific claims, such as body weight gain, or when laboratory studies have failed to generate sufficient evidence. The industry also wants EMA to accept data from field trials run outside the European Union.
Academics, industry representatives and employees of overseas regulators are among the people due to speak at the focus group event.
EMA Event, Action Plan
Tags: European Regulatory Roundup, BASG, BfArM