Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Settles Dispute Over Canary Wharf Office
The European Medicines Agency (EMA) says it has settled its dispute against Canary Wharf Ltd over its former headquarters at 30 Churchill Place in London.
When EMA entered into the lease, it expected to be in London for years, leading it to sign up to stay at the offices until 2039. Brexit forced EMA to change its plans and raised the question of who should bear responsibility for the resulting costs. EMA argues it had no say in the decision to relocate and sought the cancellation of the lease. The High Court of Justice in London ruled against EMA.
However, EMA now says it has reached an agreement with Canary Wharf Group and that it will withdraw its appeal of the High Court decision. EMA also says that it will sublet the entirety of its office space to WeWork in a long-term sublease agreement that extends to the end of the lease in June 2039.
Denmark Adds Radiopharmaceutical Project to Regulatory Collaboration With China
The Danish Medicines Agency (DKMA) has advanced and expanded its collaboration with its Chinese counterpart. After a series of meetings, DKMA and China’s National Medical Product Administration (NMPA) established a multi-year collaboration plan featuring a radiopharmaceutical quality project.
DKMA and NMPA’s selection of radiopharmaceuticals as a focal point of the collaboration reflects the fact that China and Denmark are two of a limited number of countries with expertise in the area.
“Denmark is the only country in the EU that has a drug regulatory authority that can carry out laboratory tests on radiopharmaceuticals, and it is therefore of great value that we can exchange experience with China,” Jakob Cold, co-chair of the DKMA-NMPA steering group, said.
The project, which is due to start in the fall, will compare radiopharmaceutical tests performed in China and Denmark to see if laboratories in the two countries generate the same results. Chinese officials visited Denmark this week in preparation for the project.
DKMA and NMPA are also collaborating on the documentation of clinical trial quality, a framework for medical devices, the assessment of biologics and the requirements for active pharmaceutical ingredient dossiers.
EMA Tweaks Neonate Study Concept Paper After Feedback From Gilead, Others
EMA has finalized its draft concept paper on investigating medicinal products in term and preterm neonates. The final paper is informed by feedback from organizations including Gilead Sciences and will shape EMA’s planned revision of its neonate guideline.
In finalizing the text, EMA has retained the vast majority of the draft it released for consultation in 2018. The agency has made a small number of changes in response to the nine sets of feedback it received, although some of the revisions cover fundamental points.
EMA has removed a proposal to revise its guidance in light of a definition that sets the boundary of preterm neonate at 44 full weeks of post-menstrual age. The definition prompted several comments. One respondent argued EMA should stratify preterm neonates into three gestational age groups. Another respondent asked for EMA to provide a rationale for setting 44 weeks as the cutoff.
Most of EMA’s other changes are additions to the text. When revising the neonate guideline, EMA now plans to consider the limitations of pharmacokinetic data collection, pay attention to the need for validated long-term endpoints and assess specific challenges that might impact dose delivery and absorption.
Ireland Revises Guide to Importing and Exporting Controlled Substances
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guide to imports and exports of controlled drugs. The updated guide features new sections on importing cannabis-based products and obtaining a letter of no objection (LONO) for Schedule 5 drugs.
Most of the new text addresses cannabis-based medicines. HPRA will accept applications for import licenses covering cannabis products provided the company holds the relevant controlled drug annual license. The product must also either have a medicines marketing authorization or be included in Schedule 1 of the medicinal cannabis regulations adopted in Ireland earlier this year.
Revised appendices to the controlled drug guide address the requirements a product must meet to be in Schedule 1 and the process for securing the regulatory status. The Irish regulations limit the amount of tetrahydrocannabinol that can be in Schedule 1 products.
The second revised appendix covers the packaging and labeling requirements for specified controlled drugs. HPRA wants companies to include mockups of all labels in their applications. The mockup should show the functioning of the anti-tampering device required by the rules on specified controlled drugs.
HPRA also used the update to clarify its position on obtaining a LONO for Schedule 5 controlled drugs, products that contain a small amount of a controlled substance. The guide now states what information companies should submit when requesting a LONO.
The guide also details the process for companies that want to export a Schedule 5 controlled drug. In that scenario, the company needs to obtain a valid import authorization from the country to which it plans to ship the drug.
EMA Updates Product Information Style Guide
EMA has added new sections to its guide to stylistic matters in product information. The additions address details of what information to communicate in Braille and educating patients about how to respond to the presence of residual solution on injection devices.
The Working Group on Quality Review of Documents (QRD) shared the information in a compilation of its decisions. QRD updated its position on Braille in response to the question of whether the unit should accompany the figure, for example “100 mg”, when the Braille text includes the strength. QRD said the unit should always be included when strength is to be reflected in Braille.
The second update addresses the confusion patients can experience when some drug solution is left in a prefilled pen after administration. The confusion is particularly acute when patients assume that there is a risk of under-dosing.
To ease the worries, QRD said manufacturers of overfilled devices that may contain residual solution after administration can include a statement in the summary of product characteristics and package leaflet to explain that it is normal to have some drug left over. QRD proposed another statement for manufacturers of devices that must be emptied completely.