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Posted 30 November 2015 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
MHRA to Stop Accepting Submissions on Physical Media in February
The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is to stop accepting submissions for medicines licenses on physical media on 1 February 2016. MHRA has decided to drop support for physical media after talking to trade groups about the use of the format.
Having completed the consultation, MHRA has no unresolved objections to its proposal to phase out physical media. CDs and DVDs were once an essential component of regulatory submissions, but the rise of online filings has diminished the popularity of such physical media. The trend has now reached the point at which MHRA can abandon support for physical media-based medicine licensing submissions entirely without inconveniencing the industry.
The permanent shift away from the use of CDs and DVDs forms part of the ongoing move toward online submissions at MHRA. Officials have encouraged the use of MHRA Portal for applications for marketing authorizations, submissions of active substance master files and other regulatory tasks for years, but have continued to accept physical media for when firms must share large documents. MHRA is now set to eliminate this option.
EMA Offers Guidance on Applying for the Adaptive Pathways Pilot
The European Medicines Agency (EMA) has released guidance for companies considering applying for its adaptive pathways pilot project. EMA has released the guidance while the pilot project is already underway and it is still accepting applications for meetings with health technology assessment (HTA) agencies.
To have a chance of being considered for a conclave with HTA bodies, which EMA calls Stage II meetings, companies must present a well-developed proposal. Applicants that fail to show their drug development program includes iterative processes, is reliant on the input of HTAs and will make use of real-world data will be dismissed by EMA. Drug development programs that lack one or more of these characteristics are better suited to the traditional scientific advice pathways offered by EMA.
EMA has accepted 19 proposals to date, each of which included the three essential elements of applications for the adaptive pathways pilot. Most of the applicants proposed taking a development pathway that featured an early conditional approval followed by an expansion of the label at a later date. This approach meets EMA’s need to see an iterative development strategy. Other companies met this need by proposing early or surrogate endpoints for their clinical trials.
Successful applicants went on to outline their need for the input of HTAs on a range of issues, such as whether surrogate endpoints are acceptable and the validity of data generated overseas. The final hurdle on the path to acceptance relates to the use of real-world data. EMA has signed off on pilot project applications from companies that plan to gather data from compassionate use programs to supplement small trials or use drug registries to support pay-for-performance reimbursement.
Companies that think their development programs meet these criteria are invited to contact EMA. The first step is to outline how the development program fulfills the three essential components of the pilot project, after which EMA provides feedback and asks the applicant to create a Powerpoint presentation and accompanying document. These files form the basis of the discussion at the Stage II meeting.
CVMP Outlines Revamp of Basic Surveillance of EudraVigilance Veterinary Data
The Committee for Medicinal Products for Veterinary Use (CVMP) has published a concept paper on the basic surveillance of EudraVigilance veterinary data. CVMP drafted the paper in response to the adoption of a recommendation on pharmacovigilance surveillance and signal detection in April.
Adoption of the recommendation gave CVMP a framework for the advancement of signal detection in veterinary pharmacovigilance. With this base in place, CVMP is now working to establish a process of surveillance based on assessments of periodic safety update reports (PSUR) and signal detection. The goal is to come up with a model that takes into account industry requests to be involved with signal management earlier in the process, while also reducing the workload on firms.
In the model foreseen by CVMP, manufacturers of veterinary medicines will transfer all data to the central EVVet database. This process will free manufacturers from the need to submit a line listing in the PSUR. The requirement for line listings was a major source of annoyance for companies that took part in a pilot on PSUR assessment. CVMP has given the industry until 29 February 2016 to comment on the draft concept paper. The plan is to have a draft recommendation ready for review in 2017.
EMA Sets End-of-Year Deadlines for Submission of Variations
EMA has set the dates by which marketing authorization holders (MAHs) must make certain filings if they are to be dealt with before the end of 2015. The timeline gives MAHs until 11 December to file type IB variations, either in isolation or in groupings with type IA variations.
MAHs that make submissions from 14 December, the Monday following the deadline, onward may have to wait until January 2016 for EMA to start the procedure for their filings. The date on which companies must submit type IA variations to guarantee being attended to by EMA this year is the end of November. Requests to transfer marketing authorizations between one legal entity or person and another must also be with EMA by the end of November at the latest.
EMA has released details of the deadlines to help firms prepare for the upcoming halt in regulatory activities, which will take place from 24 December to 3 January. With the transfer of a marketing authorization taking 30 days with no possibility to stop the clock, the annual holiday is something that MAHs and EMA must plan around. MAHs must submit type IB variations 30 days before implementation, while type IA notifications must be sent within one year of making the change.
The Committee for Medicinal Products for Human Use (CHMP) has adopted final guidelines on the clinical development of treatments of juvenile idiopathic arthritis and the role of pharmacogenomics in pharmacovigilance. Both documents are due to come into force next year, starting with the text on pharmacogenomics in April. Pharmacogenomics Guidelines, Arthritis Guidelines
EMA has posted guidance for sponsors on post-orphan medicinal product designation procedures. The document covers what happens once a product is granted orphan drug status, from details of the incentives available to the company, through to the annual reports that must be submitted to retain the designation. EMA also discussed transferring and amending designations. EMA Guidance
MHRA has asked the industry for feedback on its operation. The survey, which comes two years after MHRA carried out a similar exercise, is intended to give the regulator insights into how it is seen by the organizations with which it works. MHRA intends to use the feedback to guide its planning and priorities for the coming years. MHRA Notice
The European Commission Expert Group on Rare Diseases has published a report on the cross-border testing of rare diseases. The report includes recommendations for member states to share data on their assessments of tests and encourage genetic testing laboratories to participate in European Quality Assurance. Commission Report
Tags: MHRA, EMA, Adaptive Pathways, CVMP, CHMP
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