Euro Roundup: Swissmedic advises on transition to EU MDR

RoundupsRoundups | 18 March 2021 |  By 

The Swiss Agency for Therapeutic Products (Swissmedic) has shared details of how the regulation of medical devices will change in the coming months as the EU Medical Device Regulation comes into effect on 26 May.
In preparation, Swissmedic alerted industry to a notice by Kofam, the Swiss portal for human research detailing how the rules will affect sponsors as well as investigators in medical device clinical trials in Switzerland.
Kofam is advising sponsors with pending applications to file missing documents promptly so the submissions can be concluded before the new rules take effect on 26 May. From 1 April, Kofam is asking sponsors to delay making new submissions for device clinical trials until 1 May “as there is no guarantee that the application can be concluded before the law changes.”
From 1 May, Kofam is strongly recommending that sponsors use the new documents and templates designed for the incoming regulations “for reasons of procedural economy.” Decisions on applications filed in May will likely be made after the regulations come into force.
The mechanism for submitting applications will remain the same until at least 2022. Beyond that, submissions via the delayed EUDAMED database may become possible.
Swissmedic Notice, Kofam Notice

EDQM tells CEP holders how to avoid the rejection of notifications 

The European Directorate for the Quality of Medicines (EDQM) has shared advice on how holders of Certificates of Suitability (CEPs) can avoid the rejection of notifications. EDQM offered the advice to ensure the timely acceptance of proposed changes.
As EDQM explains in the notice, the requirements for the revision and renewal of CEPs say changes other than notification or a major change should be classified as minor changes by default. The sole exception is editorial changes covered by specific guidance. Any change that cannot be classified by the document must be submitted as a minor change.
Deviations from the advice can cause problems. Including changes that do not qualify as notifications in notification submissions will lead to the rejection of the application. The applicant will then need to resubmit using the correct classification and pay the associated fee.
EDQM zeroed in on the application of the rules for submission of nitrosamine risk assessments. Such submissions are minor changes, as are revised discussions on impurities in section 3.2.S.3.2. If a CEP holder makes changes to the synthesis or control strategy to address the risk of mutagenic impurities, including nitrosamines, they should classify the revision according to the EDQM guideline.  
EDQM Notice

Safety Working Party finds chlorobutanol levels generally used in medicines are safe

A European Medicines Agency (EMA) safety group has found use of chlorobutanol as an excipient at or below the permitted daily exposure (PDE) is safe for lifetime use. The Safety Working Party (SWP) said higher levels may be acceptable for short-term use.
Chlorobutanol is used at concentrations of up to 0.5% in injectables and ophthalmic formulations due to its antibacterial and antifungal properties. However, the ingredient has been linked to cardiac effects and other outcomes, leading the European Coordination Group for Mutual Recognition and Decentralised Procedures - Human to consult with SWP about its safety.
SWP analyzed the data on chlorobutanol to determine if “the levels of chlorobutanol generally used in medicinal products are safe from a toxicological point of view” and if it is possible to determine acceptable intake levels of the ingredient.
The safety group concluded “chlorobutanol levels generally used in medicinal products as excipient can be considered safe for lifetime use if they are at or below the derived PDE.” SWP also calculated a PDE that provides a four-fold safety margin to the lowest dose at which cardiac effects have been seen following intravenous administration.
SWP Report

MHRA reviews data on rise in deaths among pregnant women with epilepsy 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is reviewing data on deaths of pregnant women with epilepsy after a study found the mortality rate nearly doubled in recent years.
Early this year, Mothers and Babies: Reducing Risk through Audits and Confidential Enquiries in UK (MBRACE) published a report on the deaths of women with epilepsy. The analysis found 22 women with epilepsy died during or up to one year after pregnancy in the UK and Ireland from 2016 to 2018. From 2013 to 2015, 13 women died in similar circumstances.
Sudden Unexpected Death in EPilepsy (SUDEP) was the main cause of death for 15 of the women and four of the women were not taking epilepsy medication. The report recently led to questions in the Houses of Parliament.
Responding to the questions, a minister said the government is “unable to meet with SUDEP action and MBRRACE-UK at this time” but MHRA is reviewing the available data. MHRA is arranging to meet with patient support organizations and the wider healthcare network to understand how to better communicate risks to pregnant women and improve the reach of regulatory messaging.  
Debate Transcript, MBRRACE Report

Danish Medicines Agency tells recipients of AstraZeneca vaccine to monitor symptoms

The Danish Medicines Agency (DKMA) has asked recent recipients of AstraZeneca’s COVID-19 vaccine to monitor for signs that they are suffering from symptoms that have led many European countries to pause use of the prophylactic.
DKMA wants people who received the vaccine in the past 14 days to consult their doctor if they have symptoms that persist for more than three days, feel their symptoms getting worse or develop new symptoms days after vaccination. The agency is asking vaccine recipients to pay particular attention to bruises beyond the injection site and red spots on the skin as they may indicate low platelets.
Vaccine recipients should also contact their doctors if they develop signs of a blood clot, such as a severe headache or breathing difficulties, or other new or long-term symptoms after vaccination. The breadth of symptoms covered by the advice reflects the range of ways blood clots can manifest.
DKMA, like its regulatory peers, has no evidence to link low platelet counts, bleeding and blood clots in recipients of AstraZeneca’s vaccine to the prophylactic itself. However, DKMA does have concerns, explaining that the Danish patient who died after receiving the vaccine “had an unusual clinical picture with a low platelet count, blood clots in small and large vessels as well as bleeding.”
DKMA Notice, DKMA Letter, More

EMA extends fee waiver for developers of COVID drugs and vaccines 

EMA has extended its policy of waiving scientific advice fees for developers of products used in the prevention or treatment of COVID-19.
One year ago, EMA’s then-executive director Guido Rasi signed off on a policy to allow developers of COVID-19 treatments and vaccines to access scientific advice for free. The policy, which kept the remuneration of national competent authorities at the prior level, was due to last for one year.
Days before the policy was due to expire, the Committee for Medicinal Products for Human Use said “exceptional circumstances and imperative reasons of public health for granting fee reductions for scientific advice requests” still exist. In response, Rasi’s successor, Emer Cooke, agreed to extend the fee waiver until 15 September.
EMA Notice


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