EU Regulatory Roundup: Finland Prepares for 2020 Introduction of New Clinical Trial Regulations

RoundupsRoundups | 12 December 2019 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Seeks Feedback on Tracking Drug Safety in Pregnancy and Breastfeeding
The European Medicines Agency (EMA) is seeking feedback on its draft good pharmacovigilance practice (GVP) guideline. The draft covers specific considerations for dealing with adverse events in pregnant and breastfeeding women.
EMA wrote the GVP guideline in light of the fact pregnant and breastfeeding women are considered vulnerable populations from a drug safety perspective. The potential for products to harm unborn and breastfed children adds another layer of complication. Typically, companies bring medicines to market without showing their safety and efficacy in pregnant and breastfeeding women. Today, that data gap can be addressed once a product is on the market.
“Whereas historically, obtaining data from pregnant women on medicine use and outcomes during the post-authorization phase has been challenging, it is becoming increasingly feasible to access data and generate knowledge on safety in this population,” EMA wrote in its guideline.
The guideline outlines how the post-authorization generation of data works in practice, including by describing the use of tools including pregnancy registries to monitor product safety. EMA thinks pregnancy registries have value when extra pharmacovigilance activities are needed. In principle, EMA would prefer registries to include all pregnant women with a disease, rather than focus solely on patients who receive a particular treatment.
Other sections of the guideline cover more routine aspects of GVPs, such as periodic safety update reports (PSURs) and post-authorization safety studies. In each case, the guideline explains how to factor in the specific risks to pregnant and breastfeeding women, for example by explaining that, when relevant, PSURs need to summarize outcomes in the child after exposure to the drug in utero or via breast milk.
EMA is accepting feedback on the draft until the end of February. The ultimate goal is to finalize the text and bring it into effect around the end of next year.
Draft Guideline
Finland Prepares for 2020 Introduction of new Clinical Trial Regulations
The Finnish Medicines Agency (Fimea) has outlined the changes to the regulation of clinical trials that will come into force next month. Fimea will move to electronic submissions of clinical trial materials and revise its process for reporting unexpected serious adverse events as part of the changes.
In replacing regulations that date back to 2012, Fimea is bringing its rules and processes up to date with modern practices. The most visible sign of the modernization of the regulations is the adoption of electronic formats for the submission of clinical trial materials. Once the regulations come into force on 1 January, Fimea will receive materials via the Common European Submission Portal and its secure mail service, ending the need for study sponsors to submit a signed hardcopy document.
Fimea is also changing its approach to the reporting of unexpected suspected adverse events “to be consistent with the current practice.” In updating the document, Fimea has deleted a paragraph on the need to report summaries of adverse events every quarter or twice a year. In its place, Fimea has written that sponsors need to file lists of all adverse events “which have occurred during the period in question.”
Other changes include the creation of a new definition of interventional clinical trials, the addition of the European Union Register of Clinical Trials to the list of places to which sponsors should share trial results and clarifications to the rules on product labeling and vaccine studies.
Fimea Notice
EMA Calls for Data on Use of Antimicrobials in Animals
EMA has asked drugmakers and other groups to submit information on the use of antimicrobials in animals. The survey will inform the advice EMA gives the European Commission on antimicrobials.
In the survey, EMA asks which antimicrobials are used to treat life-threatening animal infections for which few alternative treatments are authorized. EMA wants details of the product and the possible consequences of it ceasing to be available for use in the treatment of animals.
Elsewhere, EMA asks for examples of the off-label use of antimicrobials. EMA is interested in times when an antimicrobial authorized for use in humans was given to an animal, and situations in which a drug cleared for use in one species of animal was given to another species. In both situations. EMA wants to know if alternatives were available and the impact of the loss of the drug for cascade use.
The questions about the off-label use of antimicrobials, which extend to a query about their use in unauthorized indications, could give EMA a clearer picture of how animals are treated in practice. EMA will keep the responses anonymous.
The survey is open until 6 March.
EMA Request
EMA Revises Guide to Document Access to Block Queue Jumping
EMA has updated its guide to access to unpublished documents. The changes are intended to stop people who are seeking documents from circumnavigating the queue system set up by EMA.
EMA permits people to request access to documents created or received by the agency. However, to ensure that EMA’s core activities are unaffected by the handling of document requests, the agency operates a queuing system when the documents access and publication service is at full capacity.
The system is designed to treat people seeking documents “fairly and equally.” EMA has felt it necessary to establish safeguards to ensure the system lives up to that aspiration.
“Circumvention of the queuing system would arise if requesters whose requests should otherwise be queued in accordance with the queuing rules submit requests separately without acknowledging their relevant connection. For example, circumvention of the queuing system would arise if separate individuals requested access to documents for the single use of only one requester,” EMA wrote.
EMA has responded to the threat by assessing links between requesters who it suspects are trying to jump the queue. The assessments will look at the requesters and their employers, the time of the submissions and topic of the requests to judge if they are connected. EMA will put requests it thinks are connected in the same queue.
EMA Guide
MHRA Shares Warning of Risk of Electric Shock from Medical Device
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has shared a warning that Natus Medical Denmark’s gold cup electrodes and leads may cause electric shocks.
MHRA published the warning after Natus found the devices, sold under the GN Otometrics brand name, do not “fully meet the current regulatory standard for basic electrical safety and essential performance.” The shortcomings could result in the electrode connector delivering an electric shock to the patient or healthcare professional. 
Natus is asking facilities with the affected devices to return them in exchange for a replacement that meets electrical safety standards. Alternatively, users of the device can request a refund.
MHRA Notice
Other News:
MHRA has shared details of another ranitidine recall. This time, Accord Healthcare is withdrawing all unexpired stocks of its 150mg and 300mg film-coated ranitidine medicines due to possible contamination with N-nitrosodimethylamine. Accord is advising holders of the affected stock to remove the products from their shelves and quarantine them. MHRA Notice
Portugal’s National Authority of Medicines and Health Products (INFARMED) has published details of a recall of lansoprazol products by Mylan. The recall follows the detection of out-of-specification results. INFARMED Notice (Portugese)


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy