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Regulatory Focus™ > News Articles > 2020 > 7 > Euro Regulatory Roundup: DKMA allows study drugs to be sent to patients

Euro Regulatory Roundup: DKMA allows study drugs to be sent to patients

Posted 09 July 2020 | By Nick Paul Taylor 

Euro Regulatory Roundup: DKMA allows study drugs to be sent to patients

Clinical trial sponsors in Denmark can ship investigational medicines directly to study participants under extraordinary measures allowed by the Danish Medicines Agency (DKMA).
 
Early in the COVID-19 pandemic, DKMA created a document detailing extraordinary measures sponsors can take to mitigate the pandemic’s effect on clinical trials; revisions and expansion over time have resulting in a document with a far wider scope and more lasting impact than the original version.
 
DKMA supports direct-to-patient shipping provided certain precautions are taken. The sponsor must show how the drug will be kept under appropriate conditions while in transit to the patient and have a plan for when no one is home to receive the package. Shipments must be arranged by the investigator, rather than being delivered directly by the sponsor.
 
In the most recent update, DKMA also further extended the duration of its extraordinary measures. Sponsors can now use temporary options set out in the guidance until the start of December. DKMA originally planned to allow sponsors to use the options until mid-June.
 
While DKMA may still further extend the duration of the extraordinary measures, it also wants sponsors to continually assess whether they still need the flexibility provided by the document. In the latest version of the guidance, DKMA asked sponsors to let the agency know if they are able to re-establish standard procedures.
 
The request follows a period in which Denmark has lifted lockdown restrictions without causing an increase in cases. Denmark is now averaging around 60 new COVID-19 cases per million people a day, down from more than 600 at the peak of the outbreak in April. Elsewhere in the guidance, DKMA said it has extended the time to first response to COVID-19 clinical trial applications from three to 10 working days due to “the stabilized conditions in Denmark.”
 
DKMA Guidance, More
 
Swissmedic seeks feedback on guide to implementing eCTD v4.0
 
The Swiss Agency for Therapeutic Products (Swissmedic) has released a draft implementation guide for version 4.0 of the electronic common technical document (eCTD) for consultation.
 
Swissmedic released the guide as part of its preparations for the planned introduction of eCTD 4.0 over the next few years. The updated International Council for Harmonisation (ICH) standard supports the referencing of documents using their unique ID and two-way communication between the applicant and regulatory agency.
 
The changes will affect applicants, leading Swissmedic to follow the European Union in developing an implementation guide. Swissmedic has tried to minimize deviations from the EU guide, but has had to adapt elements including the structure of the eCTD 4.0 payload message to its requirements.
 
Swissmedic is accepting feedback on the guide until the end of September. The agency is asking authorization holders, software manufacturers, regulatory affairs service providers and other groups to provide feedback. Swissmedic aims to create a final implementation guide that establishes “the right basis for successfully rolling out the new eCTD v4.0 standard” by the end of the year.
 
Swissmedic Notice
 
EMA starts consultation on controlling carcinogenic impurities
 
The European Medicines Agency (EMA) is seeking feedback on an ICH guideline about the control of carcinogenic impurities. The document features questions and answers related to a guideline that came into effect in the EU in 2018.
 
Through the new Q&A, ICH aims to “provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information that should be provided during drug development, marketing authorization applications and/or Master Files.”
 
That focus has led ICH to draft a document that covers questions such as what information agencies need to demonstrate validation of in-house quantitative structure-activity relationship models, and when it is appropriate to rely on process controls, not analytical testing, to assure product quality.
 
EMA is accepting feedback on the guideline until 3 October.
 
EMA Consultation
 
Fimea furthers multi-site approach with opening of another office
 
The Finnish Medicines Agency (Fimea) is set to open an office in a sixth location soon, furthering a multi-site strategy designed to leverage digital technologies to grow and improve its capabilities.
 
Fimea already has offices in five locations across Helsinki, Tampere and Turku, a cluster of cities in the south of Finland. This summer, Fimea will add another office in Oulu, the largest city in the north of the country. Oulu is 250 to 330 miles north of Fimea’s other offices.
 
Sari Kujala, director of internal services at Fimea, framed the opening of a fifth office as a positive for the agency’s ability to carry out the additional duties related to medical device oversight that it took on at the start of the year.
 
“We believe that multi-location activities also give us a great edge in these supervisory duties,” Kujala said in a statement. Fimea is using digital technologies to make the multi-site strategy work in the belief it “secures” its operating capacity and “promotes the safety of medicine users.”
 
Fimea Statement
 
Swissmedic authorizes distribution of remdesivir during regulatory review
 
Swissmedic has authorized Gilead Sciences to distribute remdesivir in Switzerland while waiting for an approval decision. The temporary distribution authorization means physicians can treat COVID-19 patients with the antiviral today.
 
Gilead filed for temporary authorization of remdesivir in Switzerland on 29 June. Swissmedic looked at data on quality, manufacturing, and preclinical and clinical safety and efficacy the next day, leading the agency to permit distribution of remdesivir while it continues to perform a full documentation review. The drug is not authorized but can be used by Swiss hospitals.
 
The temporary distribution authorization will remain in place until Swissmedic officially approves the drug or revokes its emergency status. Other Swiss agencies are now working to procure remdesivir and establish its price.
 
Swissmedic Notice
 
Other News:
 
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has shared an alert about cases of structural valve deterioration in recipients of Abbott’s bioprosthetic aortic heart valves. MHRA is recommending recipients of first-generation valves are considered for more frequent follow-up assessments, although it accepts COVID-19 could derail that proposal. MHRA Notice
 
MHRA has told manufacturers and suppliers of thermal cameras not to make claims “which directly relate to COVID-19 diagnosis.” Some bars and restaurants in the UK have installed thermal cameras to identify customers with an elevated temperature, one symptom of COVID-19, before they enter a building. However, MHRA has said cameras are not a reliable way to screen customers. MHRA Notice
 
The French National Agency for Medicines and Health Products Safety (ANSM) has asked patients to keep adrenaline pens until their expiry dates to help mitigate a supply disruption. The request follows a delay to the delivery of a shipment. ANSM Notice (French)
 

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