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Regulatory Focus™ > News Articles > 2020 > 8 > Euro Roundup: Swissmedic approval times slow down

Euro Roundup: Swissmedic approval times slow down

Posted 20 August 2020 | By Nick Paul Taylor 

Euro Roundup: Swissmedic approval times slow down

The Swiss Agency for Therapeutic Products (Swissmedic) took 4% longer to process each new application for a new active substance (NA NAS) through its standard procedure in 2019 than in 2018, according to a new benchmarking study.
 
The median processing time for NA NAS at Swissmedic last year was 555 calendar days. Over the same period, the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) reduced their median processing times, albeit only fractionally in EMA’s case, to further increase the gap between them and Swissmedic.
 
EMA took 401 calendar days to process applications, down just 0.2% over its prior year figure but still a 28% improvement on Swissmedic’s median time. FDA’s median processing time was 318 calendar days. That represents a 13% improvement over FDA’s median processing time in 2018 and a 43% advantage over Swissmedic.
 
Swissmedic attributed the increase in processing times to the “longer period that companies are now given for responding to the List of Questions” and “the frequent occurrence of additional text review rounds.” Text review rounds were “more protracted” than in 2018, Swissmedic said.
 
The agency shortened its processing of additional indications by 9% but still lags behind EMA and FDA in that area. Swissmedic acknowledged “the time to authorization in Switzerland is longer than in other countries despite the acceleration achieved in this area.”
 
The agency also identified opportunities to close the gap. “As the proportion of applications processed by the shortened procedures according to [the revised Therapeutic Products Act] increases, a further reduction in the processing times is expected in future,” they said.
 
Swissmedic Report
 
EDQM retains nitrosamine risk evaluation deadline
 
The European Directorate for the Quality of Medicines (EDQM) has retained the deadline by when Certification of Suitability (CEP) holders must assess the risk of nitrosamines formation in chemically synthesized active pharmaceutical ingredients (APIs).
 
In June, EMA set new deadlines for marketing authorization holders (MAHs) affected by the call for risk assessments. Despite that, EDQM has kept its original deadline, partly because most CEP holders have already finished the work, and partly because their risk assessments are a possible bottleneck for the whole nitrosamine control process. 
 
“Risk assessments for the presence of nitrosamines in active substances should be available early enough to allow MAHs to collect the relevant data for their medicinal products,” EDQM wrote.
 
EDQM confirmed its retention of the original deadline in a statement published on 17 August. The deadline passed on 31 July. EDQM did not comment on the fact that the deadline had already passed in its statement. However, the agency did ask any CEP holders that are “encountering difficulties in performing this risk assessment” to tell it “as soon as possible and propose a justifiable timeline.”
 
Nitrosamines risk assessments will become routine for suppliers of chemically synthesized APIs beginning in October.
 
EDQM Notice
 
MHRA restricts laxatives amid abuse concerns
 
New restrictions on the sale stimulant laxatives are coming to the UK market to counter risks of overuse and abuse. Changes required by the Medicines and Healthcare products Regulatory Agency (MHRA) include a minimum age for purchase, pack size limits and new safety warnings.
 
In reviewing the safety of stimulant laxatives, the Commission on Human Medicines uncovered evidence that the over-the-counter products can be misused or overused by people with eating disorders and the elderly, leading to adverse events including deaths. The data likely underestimate misuse and overuse, MHRA said.
 
New packs will contain only enough doses for two short treatment courses, reflecting MHRA’s position that over-the-counter stimulant laxatives are only indicated to treat short-term, occasional constipation. MHRA also has harmonized the indications for all products and removed “any uses not appropriate for the self-care setting.” Patients who need longer courses of laxatives, for example to treat chronic constipation, will need to get the products on prescription.
 
Other changes include harmonized warnings on patient information labels and the addition of warnings to packaging. MHRA is also prohibiting the sale of stimulant laxatives in shops to people aged 18 years and older. Children aged 12 years and older can still buy stimulant laxatives under the supervision of a pharmacist.
 
New packs reflecting the restrictions will gradually become the only stimulant laxatives sold in the UK over the coming months. 
 
MHRA Notice, More
 
EMA to demo oft-delayed clinical trial system
 
EMA has scheduled a webinar to demo its Clinical Trials Information System (CTIS). The event will give clinical trial sponsors and service providers a chance to see the status of the oft-delayed system.
 
Attendees will hear presentations about how CTIS handles tasks such as sponsor user management, as well as learn about Clinical Trial Application management and tools for user workload overview, EMA will also use the event to discuss its go-live plan for CTIS.
 
Sponsors would already be using CTIS if EMA had met its original timeline for the system. EMA was due to have a version ready for audit more than three years ago. Following a series of delays, EMA is now aiming to put CTIS through an audit in December. 
 
The webinar is scheduled for 21 September.
 
Meeting Agenda, EMA Notice
 
Finland restricts sales of paracetamol and dexamethasone to ensure supply
 
Finland has temporarily restricted the sale of paracetamol and dexamethasone to ensure the products remain available during the COVID-19 pandemic.
 
Regulators in countries including Denmark tightened the rules on the supply of paracetamol early in the coronavirus outbreak amid concerns stockpiling and increased use would create shortages. More recently, evidence that dexamethasone improves outcomes in some patients with severe COVID-19 has raised the chances of a shortage of the corticosteroid.
 
Fimea Notice (Fimea)
 
Other News:
 
MHRA is making Sanofi’s Dupixent available to children aged 6 to 11 years with severe atopic dermatitis through its Early Access to Medicines Scheme (EAMS), based on a clinical trial of 367 children. Dupixent is already licensed in the UK for use in the treatment of atopic dermatitis patients aged 12 years and up. MHRA Notice
 
MHRA has issued a Class 4 alert about Fresenius Kabi’s SmofKabiven extra nitrogen electrolyte free emulsion for infusion. The agency issued the notice after being told that two batches shipped in bags featuring labels that mistakenly state the product contains electrolytes. MHRA Notice

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