Regulatory Focus™ > News Articles > 2019 > 8 > EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit

Posted 29 August 2019 | By Nick Paul Taylor 

EU Regulatory Roundup: AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit

2764 Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
AstraZeneca Gets Clearance to Export Calquence API to EU in No-Deal Brexit
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has added the active pharmaceutical ingredient (API) in AstraZeneca’s Calquence to the list of materials cleared for export to the European Union in the event of a no-deal Brexit.
If the UK leaves without a deal the EU will treat it as a third country for regulatory purposes. One consequence of that regulatory status is that UK manufacturing sites will need written confirmations to continue shipping APIs to the EU. The written confirmations state that the site complies with good manufacturing practices equivalent to those used in the EU and is subject to regular inspections.
MHRA has helped the industry prepare for a no-deal exit by creating guidance on written confirmations and maintaining a list of the API manufacturers cleared to export to the EU, whatever happens with Brexit.
The latest update to the list features three companies that received written confirmations in August, including AstraZeneca. Following an inspection of AstraZeneca’s site in Macclesfield, England in June, MHRA issued a written confirmation stating that the facility meets the criteria needed to export from a third country to the EU.
The written confirmation issued by MHRA covers a single API, acalabrutinib. The active substance is a Bruton's tyrosine kinase inhibitor sold as Calquence in the United States, where it is approved as a treatment for mantle cell lymphoma patients. AstraZeneca is yet to win approval for the drug in the EU.
MHRA’s written confirmation for the Macclesfield API plant comes almost 18 months after it granted AstraZeneca the paperwork needed to ship ingredients from another of its UK facilities. That earlier written confirmation covered the shipment of the APIs found in the antipsychotic Seroquel and statin Crestor from an AstraZeneca facility in Bristol.
The Macclesfield site was added to the list of written confirmations at the same time as plants run by contract manufacturing organization Aesica and Alliance Medical Radiopharmacy. The Aesica written confirmation covers a clutch of off-patent APIs.
EMA Adds to Recommendations for Preventing Methotrexate Dosing Errors
The European Medicines Agency (EMA) has published recommendations on the safe use of products containing methotrexate. EMA’s advice expands on the recommendations its safety committee made last month by adding details of how patients and healthcare professionals can prevent dosing errors.
Last month, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended limiting the power to prescribe methotrexate-containing medicines to physicians with expertise in the products. That recommendation and others made by PRAC were based on a review of the use of methotrexate in inflammatory diseases and cancer. The review found differences between the dosing schedules in the two types of diseases had led some patients to take too much methotrexate, resulting in deaths.
In adopting PRAC’s recommendations, EMA has added advice aimed at patients and physicians. EMA is advising patients prescribed methotrexate for inflammatory diseases such as rheumatoid arthritis to take the medicine on the same day every week, thereby cutting the risk of accidental overdose.
EMA also advised people taking methotrexate to show their patient card to any new healthcare professional who treats them and visit their physician immediately if they experience a sore throat, fever, mouth ulcers, diarrhea, vomiting, skin rashes, bleeding or unusual weakness. Those symptoms are signs a patient may have taken too much methotrexate.
The EMA recommendations for healthcare professionals echo PRAC’s position that only a subset of physicians with relevant expertise should prescribe methotrexate. EMA also added new advice, such as recommendations that healthcare professionals who prescribe the drug stay abreast of changes to summaries of product characteristics for methotrexate medicines and decide with patients on the day of the week they will take the medicine.
EMA Notice
Swissmedic Prepares eGov Users for Downtime During IT Changeover
The Swiss Agency for Therapeutic Products (Swissmedic) has told users of its eGov services about upcoming downtime. The downtime is related to the integration of Swissmedic’s services into the Federal Administration authorization (eIAM) portal.
Today, users of online services provided by Swiss authorities use a different login procedure to access the Swissmedic system and the wider government eIAM portal. That will change on 9 September. After that date, the current Swissmedic identification and authorization verification procedures will be integrated into the iAM portal. Users will follow the CH-LOGIN procedure to access applications.
Swissmedic alerted users to the changes late last month in a notice encouraging people to delete old accounts before it began migrating data to the new system. Now, with the changeover underway, the agency has fleshed out how the migration will affect access to its systems.
On 26 August, users lost access to user administration features of the Swissmedic portal and self-registration for eMessage and ElViS, respectively a way to submit data and a vigilance system. Those systems will remain offline until the new, integrated IT platform goes live on 9 September. Swissmedic will also prevent access to all eGov services on the weekend preceding the introduction of the new IT system.
Swissmedic will use that weekend to complete the migration of existing user accounts. Users will receive an automatically generated email asking them to create a CH-LOGIN and link it to applications in the eIAM portal once Swissmedic has finished migrating their data. The onboarding link shared in the email will expire after 30 calendar days, but Swissmedic support will help users that fail to register during that window.
Swissmedic Notice
Denmark’s DKMA Offers Advice on Buying Medicines Online
The Danish Medicines Agency (DKMA) has offered advice to people considering buying medicines online. DKMA wants consumers to look for the green EU logo when assessing whether to buy from an online pharmacy.
The logo indicates that a drug regulatory authority has authorized the online pharmacy. According to DKMA, if the logo is absent from a website, “You can be almost certain that the online shop is selling medicines illegally or is located outside the EU.” In those circumstances, it is illegal to import the medicine into Denmark.
While unscrupulous online retailers could display the logo despite not having received the required authorization, DKMA thinks consumers can mitigate that risk by seeing if the logo links to a website run by an EU regulatory agency. The agency website should display a list of authorized pharmacies.
The DKMA guidance also features five questions consumers should ask themselves to help assess if a retailer is reputable. DKMA wants people to check the geographic location of the shop and confirm it dispatches medicines from within the EU. Other best practices recommended by DKMA include paying by credit card and reading the small print.
DKMA Notice
Other News:
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has issued an alert about the sale of surgical kits featuring products including kidney dishes that present a contamination risk. The agency is advising surgical teams to only use products from manufacturers that describe validated sterilization procedures in sterile applications. BfArM Notice (German)
MHRA has posted a notice about the risk of injury or infection associated with Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips. The agency said the product packaging has a CE mark “but this has not been obtained through appropriate regulatory oversight.” MHRA Notice


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Tags: EMA, MHRA, Swissmedic

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