Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Floats Changes to Guideline on Clinical Development of Epilepsy Drugs
The European Medicines Agency (EMA) has proposed revisions to its guideline on the development of medicines to treat epileptic disorders. EMA embarked on the update to encourage sponsors to run clinical development programs that generate safety and efficacy data in a variety of seizure types.
That focus reflects the nature and diversity of antiepileptic agents. Some antiepileptics are effective against a broad range of forms of the condition, while others only help people who suffer from certain types of seizure. EMA wants to have a clearer picture of whether antiepileptics are beneficial, ineffective or harmful in the range of seizure types that fall under the term epilepsy.
As such, EMA’s ideal development program features add-on studies, monotherapy trials, tests in kids and assessments of the candidate in epileptic syndromes and seizure types. However, sponsors often initially develop antiepileptics as add-ons to existing therapies in adults with partial-onset seizures. Assessments of the antiepileptics as monotherapies, in children and the elderly and in different types of seizures typically occur later.
EMA’s guidance is intended to encourage drug developers to start assessing the full spectrum of the efficacy of their antiepileptics early in development, thereby closing the gap between its ideal clinical trial program and reality.
In practice, this means EMA has strengthened a section on the desirability of exploring efficacy in a range of syndromes and seizure types as early as possible, revised the definitions of these different epileptic conditions and opened the door to the use of add-on trials to support monotherapy claims on a case-by-base basis. Elsewhere, EMA has added sections on neonates and status epilepticus, a condition that causes prolonged seizures.
EMA is accepting feedback on the draft until 17 February.
ENVI Members Seek to Draw Distinctions Between Variants of Medicinal Cannabis
Members of the European Parliament’s health committee are trying to get a draft document on the use of cannabis for medicinal purposes changed. Some of the proposed amendments reflect a desire to differentiate between cannabis and cannabis-derived medicines that follow drug development and regulatory pathways.
Several members of the European Committee on the Environment, Public Health and Food Safety (ENVI) independently put forward changes related to the distinction between medicines such as GW Pharmaceuticals’ Sativex and the broader set of products grouped under the “medicinal cannabis” label. The distinction made by the committee members is illustrated by amendment put forward by Piernicola Pedicini and Eleonora Evi.
“Whereas the term ‘medical cannabis’ may refer either to the general use of cannabis for medicinal purposes or to the treatment of symptoms of illness and other conditions with the whole, unprocessed marijuana plant or its basic extracts ... ‘cannabis-based medicines’ are medicinal products, based on [tetrahydrocannabinol], on [cannabidiol] and/or on other cannabinoids, supported by clinical trials and approved by a regulator, either EMA or other national regulatory agencies,” the European politicians wrote.
A desire to draw a distinction between the two types of products is one of the few consistent themes to emerge from the amendments. Elsewhere, the proposed changes reflect divergent opinions on the contentious topic, with some people seeking to add statements about the harm cannabis can cause while others try to talk up its benefits.
The original draft stated there is substantial evidence of the efficacy of cannabis in treating chronic pain, chemotherapy-induced nausea and multiple sclerosis spasticity symptoms. In other areas, the draft was more circumspect, noting that there is limited evidence of efficacy in a short list of other conditions.
Some ENVI members want to go further, arguing there is evidence cannabis works in Alzheimer’s, arthritis, asthma, cancer, Crohn’s disease, epilepsy, glaucoma, diabetes and obesity.
ENVI will now work toward a final version. The text is intended to encourage the European Commission “to address the regulatory and financial barriers which weigh on scientific research in the use of cannabis for medicinal purposes” and otherwise pay more attention to the topic.
EMA Calls for Experts to Help get Amsterdam Headquarters Ready
EMA has put out a tender for consultancy services related to its relocation to Amsterdam. The agency is seeking the input of consultants who can help it with tasks including the evaluation of the technical drawings of its new headquarters.
With work on EMA’s final home in the Netherlands still some way from completion, the agency is offering a contract — that could be worth €1.9 million ($2.2 million) and run for 48 months — to technical consultants that can help it with the long list of issues that will come up in the coming months. EMA thinks the support is needed to ensure it has the expertise to smoothly navigate the build and its interactions with the landlord.
The list of services sought by EMA is indicative of the types of tasks it will need to deal with in the run up to its relocation. EMA is looking for help “understanding the process of developing new premises” and with assessing “timely implementation in preparation for relocation.”
Many of the services relate to pre-relocation tasks, but EMA thinks it will need support once it is in its new home. The contract will run for an initial two years, with the option to extend it by another year twice. Post-relocation support requested by EMA includes “preparing a delivery report of the building to confirm practical completion and compliance with the prepared and agreed requirements.”
EMA is accepting bids for the work until 17 September.
EMA Updates EudraVigilance Q&A to Address new Questions From MAHs
EMA has updated a question and answer document covering the introduction of its EudraVigilance system. The document features new questions on topics including the obligation for marketing authorization holders (MAHs) to share cases between themselves.
The question on the sharing of cases between MAHs covers what a manufacturer should do when it cannot exclude the possibility that a drug made by another company is interacting with its own. In responding, EMA stated the MAH should only send the case to EudraVigilance (EV). Sending the case to the other MAH creates more work for everyone.
“If you send the cases to the other MAH as well as to EV, then they will have an obligation to process them and transmit them to EV too. The EMA will then have to merge the duplicate cases under a master. You will download both the other MAH's case & the master, the other MAH will download your case and the master & every other MAH will download all 3 cases. For all organisations, 1 case will become 3,” EMA wrote.
That question is one of four new queries addressed by EMA in the document. The other questions cover what a MAH should do if a national competent authority informs them of a case and how to handle the discovery of additional issues in individual case safety reports downloaded from EudraVigilance.
has released two draft herbal medicine guidelines for consultation. One guideline covers the quality of herbal medicinal products. The other addresses test procedures and acceptance criteria for herbal products. EMA is accepting feedback on both drafts until the end of November. Quality Guideline
, Specifications Guideline