Regulatory Focus™ > News Articles > 2019 > 10 > EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers

Posted 31 October 2019 | By Nick Paul Taylor 

EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers

3027 Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers
Ireland’s Health Products Regulatory Authority (HPRA) has reported an almost four-fold increase in its annual number of marketing authorization holder (MAH) transfers. The jump covers the run up to the date on which the United Kingdom was originally due to leave the European Union.
In 2016 and 2017, HPRA handled 209 and 208 MAH transfers, respectively. Last year, the figure shot up to 801. Throughout 2018, it looked like MAHs may need to transfer their authorizations out of the UK and to one of the other 27 member states by late March 2019 to continue supplying products to the EU.
The sharp rise in MAH transfers is one of several ways in which the impact of Brexit is evident in the 2018 HPRA annual report. HPRA also reported a 66% increase in the number of EMA scientific advice projects on which it took the lead, suggesting the Irish agency stepped up as the approach of the first Brexit deadline led the UK Medicines and Healthcare Regulatory products Agency (MHRA) to take a smaller role in EU affairs.
HPRA chief executive Lorraine Nolan noted the challenges created by the gradual removal of MHRA from the EU regulatory network in a statement to accompany the publication of the annual report.
“In what was an incredibly busy year, we engaged extensively with stakeholders to focus on our preparedness for Brexit and to help us to effectively manage the potential impact on health product supply and availability. Given the central role of UK regulators within the European network over many years, this has been a difficult and complex task on many levels,” Nolan said.
HPRA Report, Press Release
Danish Drug Agency Plans 2020 Launch of Medical Data Analytics Center
The Danish Medicines Agency (DKMA) has outlined plans to open a data analytics center next year. DKMA thinks the center will equip it to use the expanding pool of health data to offer more precise scientific advice to drug developers.
In light of the proliferation of health data, DKMA thinks drug development will accelerate and it will become easier to gather real-world safety and efficacy results to validate the findings of clinical trials. DKMA wants to contribute to and benefit from the changes enabled by the spread of data, leading it to commit to opening the center in 2020.
At the center, DKMA plans to analyze “major and new data sets for the benefit of the general public and society.” In doing so, DKMA thinks it can validate clinical trial findings in the real world, uncover new safety signals and improve the advice it offers to drug developers.
DKMA is yet to flesh out exactly how the center will benefit drug developers, although it did point to the challenge of recruiting patients with ultra-rare diseases as an example of the sort of problem it wants to tackle. While the center will officially open next year, DKMA expects to spend years after that continuing to build up its data capabilities to deliver on the vision it sketched out this week.
DKMA Notice
Swissmedic Clarifies Rules on Making Multiple Changes in 1 Variation Filing
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the structuring of applications. Swissmedic’s changes include a clarification about when manufacturers can use one Type II variation to make multiple revisions.
If all the variations relate to the same quality variation template, manufacturers can use a single Type II filing to communicate the changes to Swissmedic. For example, if a manufacturer wants to tighten up three specification limits, add a new specification parameter and delete another, it can use one Type II variation.
Swissmedic also used the update to provide information about documents related to environmental risk assessments for biosimilar filings “and additional indications that are likely to have a substantial environmental impact.”
The Swiss agency shared details of the changes, which took immediate effect, days after it updated its guide to variations and extensions. That update also addressed environmental risk assessments alongside a handful of other changes and clarifications.
Swissmedic Guidance, More
Roche Mixes up Labeling Information on Swiss Stocks of Herceptin
Swissmedic has shared details of a mixup with the labeling of Roche’s Herceptin. The problem stems from the use of the same shelf life and stability information across two formulations of the breast cancer drug.
Roche sells Herceptin in Switzerland as 150mg and 440mg solutions for infusion. The 150mg version has an “in use” stability of up to seven days at temperatures between 2℃ and 8℃, plus an additional 24 hours at up to 30℃. In contrast, the in use stability of the 440mg Herceptin formulation is limited to 24 hours at 2℃ and 8℃, plus an additional 24 hours at up to 30℃.
However, Roche’s printed and online information for the 440mg formulation used the stability figures from the 150mg version, suggesting it could be kept for far longer than is supported by the data.
After learning of the mistake and consulting with Swissmedic, Roche sent out a letter discussing the stability data. Swissmedic shared the main message of the letter on its website.
Swissmedic Notice (French)
Spanish Regulator Blasts Draft ICH Guideline on Collecting Safety Data
The Spanish Agency on Medicines and Medical Devices (AEMPS) has strongly criticized a guideline on the optimization of safety data collection. AEMPS said the International Council for Harmonisation (ICH) guideline “may jeopardize the collection of safety data from studies.”
EMA shared the draft guideline earlier this year to gather feedback on ICH’s plans to harmonize how safety data is collected “in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized.” Biopharma companies and trade groups requested a range of changes and clarifications but were broadly supportive of the text. AEMPS was not.
“We are very much concerned about this guideline,” AEMPS wrote. “It is difficult to understand why is needed and, more importantly, may jeopardize the collection of safety data from studies.”
AEMPS is concerned that the focus on drugs with “sufficiently characterized” safety profiles will have a negative effect on the identification of new safety signals after a product comes to market. The Spanish regulator framed the ICH’s proposed changes as part of a “relaxing” philosophy to safety that is “neither understood nor shared” at AEMPS.
EMA will pass the comments on to ICH to inform the third step in the guideline development process.
Other News:
MHRA has shared details of a ranitidine medicine recall by Perrigo. The recall affects certain batches of ranitidine medicines sold under various brand names, including Zantac. Perrigo initiated the recall after discovering the batches may be contaminated with N-nitrosodimethylamine, the carcinogen at the center of global concerns about ranitidine and sartan medicines. MHRA Notice
Swissmedic has released results from tests of illegally imported erectile dysfunction products. The agency found quality defects in almost half of the 140 products it tested. More than one-third of the products contained the incorrect dose. In some cases, the products contained far more of the active ingredient than is found in genuine medicines, raising safety concerns. Swissmedic Notice
EMA has asked companies to file Type IA and Type IAIN variations for 2019 by 29 November. EMA Notice


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