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Posted 10 March 2016 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
The European Parliament has endorsed a draft law intended to encourage the responsible use of antibiotics in animals. Under the terms of the proposal, the European Commission will monitor the use of animal antibiotics in member states and report the data regularly, while veterinarians will be made to raise awareness about antimicrobial resistance.
Rapporteur Jasenko Selimovic sees the law helping to contain transmissible animal diseases in three separate ways.
“First, it links animal health and welfare and connects it to human health. This direct link, together with emphasis on responsible use of antibiotics, will help us fight growing antimicrobial resistance. Second, it enables the authorities and producers to focus more closely on prevention and control of transmissible animal diseases. And third, it merges around 40 legal acts into one basic act,” Selimovic said.
The upshot of these changes for farmers, traders and animal professionals is that Europe is set to put more emphasis on stopping problems before they begin. Farmers will be “obliged” to adhere to the principles of good animal husbandry and think before using veterinary medicines, requirements the European Parliament sees leading to more responsible use of antibiotics. The European Commission is to back up the initiatives by gathering data on country-by-country use of antibiotics, putting it in a position to identify member states that are failing to comply with the law.
By signing off on the law, European politicians cleared the text to be posted in the EU Official Journal, 20 days after which it will come into force. As well as bringing into force the aforementioned requirements on antibiotic use, the passing into law of the text will also give the commission powers to urgently address emerging diseases that could have a “highly significant impact” on public health and agricultural production.
The European Medicines Agency (EMA) is seeking feedback on the implications of using stem cells and monoclonal antibodies to treat animals. EMA’s Committee for Medicinal Products for Veterinary Use (CVMP) has started the process by publishing a pair of problem statements, in which it lays out its take on aspects relating to the technologies and puts specific questions to the industry.
CVMP plans to publish guidance on the use of innovative types of medicine including stem cells and monoclonal antibodies to treat animals, but currently lacks all of the information it needs to start the process. Experience gained in the use of the technologies in human medicine has given CVMP a base from which to build, but left it with some animal-specific problems. To address the knowledge gap, CVMP has set up the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT), which, in turn, has turned to the industry for answers to some of the questions it is facing.
ADVENT’s stem cell problem paper is about sterility. As parenterally-administered products, stem cell therapies must be sterile. However, the fact that such treatments are based on living cells means they are unsuited to physical, chemical and filtration methods of sterilization. ADVENT foresees firms working around these issues by establishing an overall microbiological control strategy that prioritizes the use of qualified and tested starting materials, plus validated aseptic manufacturing processes. In doing so, firms can control contamination at each step, instead of relying solely on final testing.
While ADVENT is clear on how it sees veterinary medicine manufacturers broadly addressing these aspects of the process, it wants to learn more about the specifics of how to achieve these objectives. As such, it put the following question to the industry: “Are there any recommendations regarding the use of other approaches or methods or further issues applicable for the sterility control of stem cell-based products in process and/or at the finished product?” ADVENT has given the industry until 15 May to respond.
The same deadline applies to the problem statement regarding monoclonal antibodies, a class of products about which ADVENT has several more questions. ADVENT’s questions range from whether its current guidance on characterization is appropriate and specific to what additional data should be required of companies that wish to administer monoclonal antibodies to pregnant animals. The committee is also seeking feedback on what data drug developers should generate to demonstrate the safety of their monoclonal antibodies in terms of adverse effects on the immune system.
EMA Statement, Stem Cells, Monoclonal Antibodies
The Committee for Medicinal Products for Human Use (CHMP) has adopted a revised guideline on epidemiological data on blood transmissible infections. CHMP made the changes to provide plasma master file (PMF) holders with additional guidance on topics including residual risk calculations.
EMA’s CHMP has made major changes to the section on risk estimation as part of attempts to ensure filings for PMF certifications are backed up by sufficient epidemiological data on blood transmissible infections. As such, CHMP has updated its advice on how applicants can calculate the risk of routine testing failing to detect viruses in the blood.
Other changes include the extension of the monitoring period, which was previously capped at three years because of the limitations of the dataset, and revised advice on the value of control charts as a way to spot trends in viral marker rates. CHMP has also used the revision to impose epidemiological data requirements for approval.
The changes reflect the impact of the accrual of data and understanding since CHMP last revised the text in 2011. Having taken the proposed changes through a consultation period last year, CHMP has now decided on a version of the text that it is willing to adopt. The text is due to come into force at the end of August.
EMA has revised an orphan drug-related section of its post-authorization procedural Q&A for users of the centralized procedure. The revised section addresses the process for companies that want to add non-orphan indications to previously authorized orphan drugs.
Under the revised advice, companies still have the option of simply making a separate application for the non-orphan indications. The new advice covers the process for companies that want to withdraw their orphan designations. In these instances, EMA is advising companies that are yet to withdraw a designation at the time of submission to mention their intent to do so in their cover letters. EMA is asking companies to make withdrawal requests within two days of receiving an opinion from CHMP.
Companies that fail to meet EMA’s timelines will face consequences. “The validation of application will become automatically null and void with retroactive effect,” the regulator wrote.
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has reported three Field Safety Notices from CME. The notices relate to the CME T34 & T60 pumps and syringe extension sets. The pumps may deliver an “unintended bolus” and then cease infusing. CME has also pointed out a leakage at a connection in an extension set. MHRA Notice
The European Directorate for the Quality of Medicines and Healthcare (EDQM) is to host a one-day workshop co-organized by the Chinese Pharmacopoeia Commission. At the event, attendees will learn about recent changes to pharmacopoeias in Europe and China. EDQM Statement
Tags: European Regulatory Roundup, EU medical news, antibiotics, monoclonal antibodies
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