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Regulatory Focus™ > News Articles > 2020 > 9 > Euro Roundup: Swissmedic resumes on-site inspections

Euro Roundup: Swissmedic resumes on-site inspections

Posted 03 September 2020 | By Nick Paul Taylor 

Euro Roundup: Swissmedic resumes on-site inspections

The Swiss Agency for Therapeutic Products (Swissmedic) has resumed regular on-site inspections amid an easing of COVID-19 restrictions in Switzerland.
 
The agency is taking precautions to mitigate the risks created by in-person interactions between its inspectors and the employees of the companies they visit. Inspections are only taking place if Swissmedic staff and targeted companies can adhere to measures related to distancing, hygiene and the tracing of coronavirus infections.
 
Swissmedic or regional medicines inspectorates — four cantonal bodies that work with the regulator to assess manufacturers and wholesalers — will define the inspection process but the onus is on the targeted companies to take actions to ensure a safe visit. .
 
In advance, Swissmedic is sending out questionnaires that allow targeted companies to confirm that required protective measures are in place. Companies are expected to offer meeting rooms with “sufficient space,” restrict the number of people present and make some resources available electronically. Face masks must be worn if social distancing is temporarily impossible.
 
Those expectations are in line with those of other regulators that have restarted on-site inspections. Swissmedic is also looking to companies to take additional actions, such as installing plexiglass panels between workstations and ensuring appropriate distancing for meal breaks.
 
Swissmedic Notice
 
Denmark extends measures to address supply shortages until end of 2020
 
Emergency measures intended to stop COVID-19 causing drug shortages will continue in Denmark through the end of the year, according to the Danish Minister of Health.
 
In March, the health minister empowered the Danish Medicines Agency (DKMA) to make companies and other players in the supply chain submit details of their stock levels. Armed with that data, the Danish regulator could ask companies to increase supplies or reallocate medicines and devices to the parts of the healthcare services facing shortages. DKMA could regulate prices if necessary.
 
The health minister revised the emergency measures in April, for example by adding a provision that empowered DKMA to prevent pharmacists from dispensing non-prescription medicines to people outside of certain specified groups. The extended measures are the same as those adopted by the health minister in April.
 
The extension comes weeks after a resurgence of the coronavirus in Denmark led authorities to halt the easing of restrictions on public gatherings. The government was due to permit gatherings of up to 200 people in early August but paused its plans in response to a rising case load. The number of new cases has fallen over the past two weeks. 
 
DKMA Notice
 
EMA enlists patients, healthcare professionals to help ICH revise trial guidance
 
The European Medicines Agency (EMA) has gathered feedback from patients and healthcare professionals to inform the ongoing revision of good clinical practice (GCP) guidance. The feedback relates to the International Council for Harmonisation’s (ICH) E6 guideline on GCPs.
 
Considering the feedback, ICH is revising the guideline to ensure it meets “the needs of those conducting or participating in clinical trials.” That focus, coupled to a related commitment to engage with patient representatives and academic clinical researchers, created a problem for ICH that it turned to EMA to help address.
 
EMA’s relationships with organizations of patients and healthcare professionals enabled ICH to work around a limitation of its network. The minutes show the lack of patient and healthcare professional involvement in ICH was discussed at the EMA meeting. ICH wants that to change.
 
“ICH would very much welcome to have in the future an international patient organization and an international healthcare professional organization with an interest in ICH, applying and officially becoming an observer in ICH,” the meeting minutes state.
 
Until ICH establishes such relationships, it plans to engage with patients and healthcare professionals by publishing information on its website and participating in events such as the meeting convened by EMA.
 
EMA Update, Meeting Report
 
Italy’s AIFA creates process for controlling access to limited remdesivir stocks
 
Italian physicians who want to treat patients with remdesivir with must complete a form and email it to the Italian Medicines Agency (AIFA), in a process established to limit access to Gilead Sciences’ antiviral, marketed as Veklury.
 
Gilead struck a €63 million ($74 million) deal with the European Commission (EC) to provide the region with enough remdesivir to treat around 30,000 patients. With COVID-19 cases rising across the European Union over the past six weeks, that stockpile is waning.
 
AIFA is accepting requests from physicians who are treating patients in a condition corresponding to the indication covered by the remdesivir authorization. Like other European countries, AIFA wants physicians to administer five-day courses of remdesivir.
 
To ensure timely treatment, AIFA is prioritizing the processing of requests for access to remdesivir. AIFA expects to handle requests within a few hours. A Ministry of Health warehouse will ship drugs to physicians with approved requests twice a day.
 
The process will remain in place until at least the end of the month. The EC is expected to secure additional supplies for October onward through a joint procurement agreement.
 
AIFA Notice (Italian)
 
AEMPS authorizes J&J to run first COVID-19 vaccine trial in Spain
 
The Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized Johnson & Johnson to run a midphase trial of its COVID-19 vaccine. The authorization marks the first time a company has been cleared to test a COVID-19 vaccine in Spain.
 
J&J is set to enroll 190 people at three Spanish hospitals and another 360 from sites in Germany and the Netherlands. The dose-finding study will evaluate J&J’s adenovirus vaccine Ad26.COV2.S in two groups of healthy volunteers, one aged 18 to 55 and another aged 65 years and older. Unlike other leading vaccine developers, J&J plans to assess a single dose of Ad26.COV2.S in its pivotal program.
 
Spanish sites are absent from the list of study centers that are gearing up to enroll people in the 60,000-subject Phase 3 trial, although the resurgence of the coronavirus in the country potentially makes it a good location for vaccine research. Spain’s seven-day rolling average of daily new cases per million people is at a record level, although that likely partly reflects increased testing.
 
The level of SARS-CoV-2 transmission in Spain means study subjects are more likely to encounter the virus than in many other countries, cutting the time it takes to show if a vaccine provides protection. AEMPS said it is in contact with other companies about the possible inclusion of Spanish sites in their COVID-19 clinical trials.
 
AEMPS Notice (Spanish)

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