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EU Regulatory Roundup: Swissmedic Creates Signal Notification Form in Change to 2020 Requirements

Posted 21 November 2019 | By Nick Paul Taylor 

EU Regulatory Roundup: Swissmedic Creates Signal Notification Form in Change to 2020 Requirements

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
Ireland Seeks Industry Input on Regulatory Plan Through to 2025
 
Ireland’s Health Products Regulatory Authority (HPRA) is seeking feedback to inform development of its strategic plan for 2021 to 2025. HPRA wants input on how the sectors it regulates will change in the next five to 10 years and feedback on how well it currently communicates with stakeholders.
 
When HPRA established its current strategic plan, it set itself the objectives of optimizing regulatory systems, improving communication, supporting innovation, adding expertise and enhancing access to health products. Those goals have remained touchstones for HPRA over the subsequent years, but its efforts to meet them have been affected by external forces, notably Brexit and changing regulations at the European Union level.
 
HPRA highlighted Brexit and changing EU regulations as key drivers of its strategy for the next five years. With the consequences of the United Kingdom’s vote to leave the EU still uncertain, HPRA is unable to say how Brexit will affect its operations out to 2025 but it thinks “changes to the supply of some human or veterinary medicines and medical devices ... cannot be ruled out.” HPRA also sees opportunities to fill the gap created by the UK’s departure from the EU regulatory network.
 
The impact of incoming EU regulations should be easier to predict, but outstanding questions about the implementation of rules on clinical trials, veterinary medicines and, in particular, medical devices and in vitro diagnostics means HPRA faces some uncertainty in these areas, too. HPRA expects the new rules to “impact significantly on the operation of the relevant regulatory system.”
 
HPRA mentioned innovation, partnerships and public trust as the other three key drivers of its 2021 to 2025 strategy. The agency expects these drivers to result in more collaborations and lead it to make its decision-making process more transparent.
 
While HPRA has identified the drivers of its next regulatory strategy, it is yet to develop the plan. To inform that work, HPRA has posed a set of questions to groups that will be affected by the strategy. HPRA wants feedback on the focus of its contribution to EU and international regulatory networks, its role in legislation and policy development and how well it communicates with stakeholders.
 
HPRA is accepting feedback until 13 December.
 
HPRA Notice
 
EMA Posts Draft VICH Guidance on Waiving Vaccine Animal Tests
 
The European Medicines Agency (EMA) has shared draft guidance on waiving laboratory animal batch safety testing for veterinary vaccines. EMA is gathering feedback to inform the Veterinary International Conference on Harmonization’s (VICH) development of the document.
 
In the draft, VICH explains that batch release of veterinary vaccines in several regions requires the submission of safety test data from animals. VICH wants to harmonize the rules on batch release and, in doing so, reduce the need for vaccine manufacturers to run separate studies to meet the needs of regulators in different countries.
 
To do so, VICH has created draft guidance on laboratory animal batch safety tests and the criteria for waiving the studies. VIST is proposing that regulators waive the tests “when a sufficient number of production batches have been produced under the control of a seed lot system and found to comply with the test, thus demonstrating consistency of the manufacturing process.”
 
Typically, VICH thinks existing information from routine batch quality control and pharmacovigilance activities will be sufficient to support a waiver. VICH is proposing that vaccine manufacturers submit a summary of their data and a conclusion about the maintenance of product safety to regulators.
 
The guidance lists some situations in which manufacturers may need to perform laboratory animal batch safety testing. These examples include times when a company makes significant changes to its manufacturing process or receives reports of unexpected adverse events. Ongoing testing may also be needed when working with toxoid vaccines and other products with particular safety risks.
 
EMA is accepting feedback on the draft until 10 April. 
 
Draft Guidance
 
Swissmedic Creates Signal Notification Form in Change to 2020 Requirements
 
The Swiss Agency for Therapeutic Products (Swissmedic) has created a signal notification form as part of a change in how it will collect safety data. Starting in January, Swissmedic will ask marketing authorization holders (MAHs) to use the form to send initial signal reports and some follow-up filings.
 
Swissmedic designed the new notification form for use in the communication of initial safety signals and follow-up reports on signals that lack a Swissmedic Signal ID. In moving to the new reporting system, Swissmedic is eliminating the need for MAHs to submit a covering note alongside these signal reports.
 
The notification form will capture critical information about the MAH, the product involved and the safety issue. Swissmedic wants MAHs to describe the safety signal, discuss existing or planned risk minimization measures in other territories and explain how they will manage the threat to Swiss patients. MAHs need to explain any differences between the global and Swiss risk minimization plans.
 
MAHs should append any additional documents related to the signal, such as assessment reports from other regulatory agencies, to the notification form.
 
Swissmedic wants MAHs to use a different process to inform it of information about signals that already have a Signal ID. In that scenario, MAHs should not use the notification form. Rather, Swissmedic wants MAHs to attach a covering note with a subject line that states the Signal ID and other key information, such as the name of the active substance involved.
 
The creation of the notification form triggered the third change to the safety signal guidance in 11 months. Swissmedic introduced the guidance at the start of the year and immediately updated it to extend an implementation deadline and correct an error. Swissmedic made further changes in April, adding two new chapters on risk-minimization measures and filing to change product information.
 
Swissmedic Documents
 
France’s ANSM Seeks Feedback on Real-Time Release Testing Annex
 
The French National Agency for Medicines and Health Products Safety (ANSM) is seeking feedback on an EU real-time release testing and parametric release document. ANSM plans to transpose a translation of the EU document into French law.
 
An updated version of the EU guidelines came into force late last year. The update expanded the scope of the document beyond the use of parametric release, a form of quality assurance, for routine testing of terminally sterilized products. In the updated version, the European Commission addressed a related approach, real-time release testing, for the first time.
 
Now, ANSM wants to bring the updated guideline into French law. To do so, ANSM has translated the guideline into French. The translated document should convey the same information as the original.
 
To ensure that is the case, ANSM is asking for feedback on the translation. ANSM is accepting comments on the draft translation until 15 January.
 
ANSM Notice (French)
 
Other News:
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert about the recall of more ranitidine medicines. Creo Pharma and Tillomed Laboratories are recalling all unexpired stock of certain batches of their ranitidine medicines over concerns about contamination with N-nitrosodimethylamine. The recall follows similar actions by companies including GlaxoSmithKline. MHRA Notice
 
The Finnish Medicines Agency (Fimea) has alerted pharmaceutical brokers of new rules that will apply to them starting next year. Fimea Notice (Finnish)

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