Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Lord Tries to Reassure Politicians About Brexit Life Science Strategy
A member of the United Kingdom’s House of Lords has tried to reassure politicians who questioned the effect of Brexit on life sciences that the government has the situation under control.
David Prior, the parliamentary under secretary of state for health in the Lords, made the comments in a letter to the interim chair of the House of Commons science and technology committee. In the run up to the Brexit vote, the committee spoke to the life science sector about the pros and cons of being regulated by the European Union. The resulting report, while being published by a committee that was supposed to be neutral on the topic, identified major concerns about the prospect of Brexit.
In response to these findings, the committee urged the government to immediately establish plans to ensure the life science sector would be insulated from the fallout from a vote to leave the EU. The immediate aftermath of the Brexit vote made it clear the government's preparations were lacking in these and many other areas. Now, approximately six weeks after the vote, Prior wants the committee to know this is no longer the case.
“I want to reassure the committee that the government is examining the impacts of the UK’s exit from the European Union on the life sciences sector,” Prior wrote. “By working together, with pace, vision and shared commitment I believe we can ensure that the process of defining our new relationship with the EU does not undermine confidence in our growing life science sector.” Prior cited the formation of the UK EU steering group as evidence the government is in control.
EMA Adopts Guidelines on Cell-Based Cancer Immunotherapies, mAbs
EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted revised guidelines on cell-based cancer immunotherapies and monoclonal antibodies (mAbs). The regulator updated the documents in response to changes to best practices relating to the protection of animals used for scientific purposes.
With the changes, which relate to the evolution of EMA’s 3R — replacement, reduction, refinement — principles, being relatively minor, CHMP and the Biologics Working Party have pushed through the revisions without putting them to up for public consultation first. In both the immunotherapy and mAb documents, the 3R-related changes affect three sections. CHMP has also used the update as an opportunity to make other changes it described as “minor and uncontroversial.”
The 3R-related changes to the immunotherapy guideline, which specifically addresses the potency testing of such drugs, covers the use of animal models. Whereas the text that came into force in 2008 said, “The use of relevant animal models should be fully explored,” the revised version says the use of animal models as potency assays should not be the principal goal. EMA will accept in vitro assays for release testing.
CHMP made similar small changes to its text on the development, production, characterization and specification of mAbs. The revisions include the removal of a reference about harvesting mAbs from ascites fluid, a liquid that accumulates in the abdominal cavity, and the addition of a line about the need to thoroughly justify the use of in vivo assays to assess the biological activity of a mAb. The earlier text was more accepting of the use of in vivo assays.
EMA Starts Consultation on Producing Water of Injectable Quality
EMA has started a consultation on the production of water of injectable quality. The draft question and answer document covers the use of reverse osmosis in the manufacture of water for injection (WFI) and the control of biofilms.
Members of EMA’s good manufacturing practice (GMP) working group began work on the Q&A after an update to the European Pharmacopoeia WFI monograph. That update added a section on reverse osmosis, a topic to which EMA has devoted a substantial portion of its Q&A document. Through the Q&A, EMA is aiming to flesh out the brief reference to reverse osmosis in the monograph, giving companies the information they need to use the technique in the production of WFI.
In the document, EMA addresses the main concerns with using reverse osmosis, the main elements a company must consider when designing a system that uses the technique and the sampling and qualification the approach entails. This information is intended to give manufacturers a preliminary set of guidelines to work from while EMA completes its ongoing revision of Annex I of the GMP guide. The draft Q&A is open for comment until 4 November.
EMA has also used the draft Q&A to outline its views on biofilms, groups of microorganisms that can form wherever moisture, nutrients and a surface are present. The Q&A covers the control strategies manufacturers can adopt to minimize the risk of contamination, as well as the steps they can take to remove a biofilm once it has taken hold.
EMA Unveils 13 Initiatives to Support Timely Access to Veterinary Vaccines
The European Medicines Agency (EMA) has committed to 13 initiatives intended to ensure timely access to veterinary medicines. EMA formulated the action plan in collaboration with the Heads of Medicines Agencies (HMA), giving it a broad base of support as it embarks on a program to address current gaps in vaccine coverage.
Officials at EMA and HMA jointly published a report on their intentions after meeting to discuss how best to address perceived problems with the regulation of vaccines. Specifically, EMA and HMA wanted to evaluate whether it is necessary to change evidence requirements for approval of certain vaccines to increase the number of animals and pathogens that can be addressed by preventative products. This line of thinking was driven by worries that existing requirements, while appropriate for some vaccines, were stymying the development and approval of niche prophylactics.
Having discussed the topic and accepted that the current systems is creating problems, particularly for vaccines targeting minor use, minor species (MUMS), EMA and HMA have identified a sizable list of suggested improvements. Some of these improvements, such as the ending of the need to run field efficacy studies, will require changes to directives. EMA and HMA see the field study change as a top priority. Regulators are equally keen to accept serology as a surrogate marker of efficacy. This can be achieved by changing guidelines.
The next step is to turn these and other ideas into actions. EMA has published a list of its initiatives in the area of veterinary vaccines and provided details of their statuses. In the “ongoing” pile are work to revise MUMS guidelines — an initiative that was given impetus earlier this year with the release of a draft document — and another to address the need for vaccines for epizootic diseases such as foot-and-mouth disease. EMA is aiming to publish a draft concept paper on data requirements for vaccines against epizootic diseases next month.
Other initiatives that are ongoing include revisions to risk-benefit considerations to take into account the type of vaccine and other circumstances, and a move to establish public-private partnerships as part of Horizon 2020. The one initiative that is listed as yet to start is perhaps the most arduous of them all: working with European Commission to make the legal framework more amenable to the timely availability of vaccines.
Press Release, EMA Report