Posted 10 December 2015
By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Review Calls on Regulators to Limit Levels of Antimicrobials in Production Plant Wastewater
A review commissioned by the British government has called for regulators to limit the levels of antimicrobials in manufacturing plant wastewater. By capping the concentration of antimicrobials in wastewater, regulators may contribute to a stemming of the rise of drug-resistant strains of bacteria.
The idea put forward in the report is for maximum limits for concentrations of antibiotics in water to be enshrined in good manufacturing practices (GMPs). Such a move would harmonize the standard around the world, resulting theoretically in active pharmaceutical ingredient (API) plants in emerging markets sticking to the limit as rigorously as their counterparts in Europe and North America. This is the ideal model for the review team. In the near term, a less all-encompassing approach may help.
“There are currently no, or very few, standards for API discharge anywhere in the world; either for municipal waste treatment plants or for the manufacturing companies,” Jim O'Neill, the former chief economist at Goldman Sachs who was appointed to lead the review, wrote in the report. O’Neill thinks this is partly a consequence of a lack of data on the concentration of antibiotics at which resistance develops. In the absence of such data, O’Neill proposes setting a standard based on what we know.
O’Neill cited a paper published earlier this year as a starting point. The paper proposes setting the cap at 10% of the maximum limit, a level at which the researchers think resistance is unlikely to develop. As new data are generated, levels could move up or down to take into account our understanding of at what point resistance starts to develop. O’Neill wants the standard to come in soon, but accepts manufacturers will need time to change their processes without affecting antimicrobial supply.
The wastewater concentration cap is part of a suite of suggestions put forward to tackle resistance by controlling the presence of antimicrobials in the environment. Several of the other ideas relate to the use of antimicrobials in agriculture. “We need a global target to reduce antibiotic use in food production to an agreed level per kilogram of livestock and fish, along with restrictions on the use of antibiotics important for human health,” O’Neill wrote.
AMR Report, Reuters
EMA Schedules Meeting on Challenges for Immuno-Oncology Drug Approvals
The European Medicines Agency (EMA) has called a meeting to discuss the challenges of bringing immuno-oncology drugs to market. EMA will use the meeting to talk over factors developers should consider when designing clinical trial programs to support approval of immunotherapies in cancer treatment.
European regulators have already approved immuno-oncology drugs such as Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda, but, with many more such products coming down the pipeline, have decided there needs to be a discussion about issues relating to the class of treatments. The two-day event, which is being organized in collaboration with the Cancer Drug Development Forum (CDDF), will take place in London in February.
At the event, EMA wants to go over how to select patient populations, new clinical trial designs and the assessment of the relative efficacy of immunomodulating therapies. The event is also expected to dig into the rationale for mechanisms of action in a range of tumor types and the use of combinations of immunological-based products, a therapeutic approach that is expected to play a big role in cancer care in the coming years.
The involvement of CDDF means the event will have access to a ready-made group of cancer experts, including the physicians and academics who make up the board of the organization. CDDF, an Austrian nonprofit, counts Eli Lilly, Roche and Pfizer among its partners.
Clutch of Autism Diagnostic Tools Secure Backing of EMA
EMA has issued letters of support advocating further research into a collection of diagnostic tools for use with people with autism spectrum disorder. The tools are designed to stratify patient groups, measure clinical symptoms and predict outcomes.
European Autism Interventions — A Multicentre Study for Developing New Medications (EU-AIMS) asked EMA for follow-up qualification advice relating to the five approaches earlier this year. Having assessed the approaches, EMA has issued five letters of support. Four of the letters cover methods to stratify patient populations, either by measuring executive function and basic emotions, recording brain activity or tracking eye movements.
The brain monitoring proposals use electroencephalogram (EEG) and magnetic resonance imaging (MRI), techniques that can respectively show the gamma activity or examine differences in white matter tracts. EU-AIMS researchers think the monitoring of gamma activity while showing people either upright or inverted faces could be used as a diagnostic or to evaluate the efficacy of drugs. EMA wants EU-AIMS to pursue this idea further.
Officials at the regulator also gave their backing to further research into the use of measurements of basic emotions and executive function in the stratification of patients and prediction of clinical outcomes. EU-AIMS thinks it may be able to stratify people by tracking their eyes during certain experiments. The use of clinical outcomes assessments is proposed as a way to measure symptoms.
Executive Function, EEG, COA, MRI, Eye Tracking
Swissmedic Changes Process for Updating Details of Authorization Holders
The Swiss Agency for Therapeutic Products (Swissmedic) has changed the process for updating and transferring authorizations. Swissmedic is no longer allowing changes to the name of a product as part of an application to transfer ownership of an authorization.
Companies must now file the change of name separately, incurring a fee in the process. Swissmedic adopted the new policy as part of a suite of changes to the handling of the process for updating and transferring authorizations. Applications to change the name or domicile of the authorization holder are now being done at the same time as filings to update the details listed in the establishment license.
Swissmedic has also adapted a new approach to the approval of the use of new logos or corporate designs on packaging. Companies wishing to use a new logo must file an application specifically for this purpose. Once again, this carries a fee. After Swissmedic has signed off on the logo, the company can adopt the new design at the same time as making other changes to the authorization without providing supporting documentation to the regulator.
Stallergenes Greer has recalled immunotherapy products manufactured at a facility in France. The recall follows a notification from Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) about technical problems relating to an IT system implemented at the facility in August. Production at the site is on hold until the issues are resolved. Press Release
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a safety alert about Pfizer’s Genotropin GoQuick pens. MHRA released the alert after learning that a flaw in some of the pens could enable patients to administer a larger-than-intended dose by applying excessive force. No complaints or adverse events have been reported. MHRA Alert
The MedicalDevicesLegal blog has reported that the trilogue on medical devices is unlikely to be completed by the end of the year. Erik Vollebregt, the regulatory and legal expert who writes the blog, now expects it to take until the middle of 2016, possibly later, for regulations to be finalized. MedicalDevicesLegal