European Regulatory Roundup: EMA Downplays Impact of Court Order on Trial Transparency (8 October 2015)

Regulatory NewsRegulatory News | 08 October 2015 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EMA Downplays Impact of Court Order on Trial Data Transparency

EMA has downplayed the likely impact of a court order involving access to marketing authorization documents on the clinical trial data transparency agenda. The interim order of the court suspended EMA’s decision to give Novartis access to documents relating to a drug from Pari Pharma.

Dr. Sam Hamilton, chair of the European Medical Writers Association (EMWA), had asked EMA about the risk of the ruling affecting Policy 0700, which covers the publication of clinical data. In a response posted online by Hamilton, Juan Garcia Burgos, head of medical and health information at EMA, sought to downplay the link between the court order and the policy. “The position of the Agency is that in no way does the interim order bring into question Policy 0070,” Burgos said.

As EMA sees it, the order in the Pari-Novartis case is outside the scope of the policy because the dispute is over documents other than clinical study reports. Also, the order makes no ruling about whether the information is confidential. EMA is sticking to its existing strategy. “Case narratives should not be redacted in full and they should be instead anonymized. Further guidance on the anonymization of clinical reports ... will be published in due time,” Burgos said.

While EMA sees the court order as a separate issue from Policy 0700, the legal action has an effect on other aspects of its operation. EMA decided to grant Novartis access to documents relating to the marketing authorization of Pari Pharma’s drug, only to have the court suspend its action. Further twists are possible. “EMA is carefully considering our options, including the possibility to lodge an appeal against the interim order within the statutory limits,” Burgos said.

EMA Statement, EMWA Questions

EMA’s Biosimilar Team Posts Draft Guideline on Protein Immunogenicity

The Biosimilar Medicinal Products Working Party (BMWP) has posted a draft update to guidelines on assessing the immunogenicity of biotechnology-derived therapeutic proteins. Revised aspects of the guidelines cover detailed requirements for assays and the analysis of clinical significance.

BMWP began updating the text to build into its advice experience gained from marketing authorization applications since the original document was published in 2006. The document is focused on how to systematically evaluate unwanted immune responses against therapeutic proteins. Within this, the guideline covers a wide range of topics, a fact BMWP thinks may mean its recommendations need adapting to the unique features of each development program.

While BMWP is open to drug developers interpreting the recommendations in light of the specifics of their programs, preferably after seeking advice from EMA, some core tenets of the guidelines are broadly applicable. The guideline stresses the importance of developing or selecting assays to assess immune responses. Such assays should go beyond antibody detection and assess cell-mediated responses. Applicants are also expected to include data to validate assays in their regulatory filings.

The guideline covers what to do when anti-drug antibodies (ADAs) are detected, too. Sometimes ADAs have no effect on the safety or efficacy of a product, but they must be factored into the risks of clinical development. BMWP expects companies to maintain such vigilance post-approval, starting with the inclusion of immunogenicity in the safety specifications of marketing applications. The draft is open for comments until the end of January.

Draft Guideline

Sepodes Re-Elected as Chair of Orphan Medicinal Products Committee

The Committee for Orphan Medicinal Products (COMP) has re-elected Bruno Sepodes for another three-year term as its chair. Lesley Greene was re-elected for another three years as vice-chair of COMP at the same time.

Sepodes, a professor of pharmacology and pharmacotherapy at the University of Lisbon, was first elected chair of COMP in 2012, four years after he joined the committee. Having been elected for a second three-year term, the Portuguese professor has committed to using his time in at the helm to tighten links between COMP, other parts of EMA and its global regulatory peers. “The increasing levels of complexity of new applications for medicines call for deeper cooperation,” he said.

Echoing the views of the recently re-elected head of the Committee for Medicinal Products for Human Use (CHMP), Sepodes also vowed to work more closely with patient representatives. COMP has been at the forefront of this trend, having appointed a patient representative as its vice-chair since it began life in 2001. Greene, a volunteer patient representative for Eurordis, is the latest in the line of vice-chairs. Having joined COMP in 2009, Greene became vice-chair in 2012. 

Press Release

Veterinary Pharmacovigilance Project to Restart in 2016

The European Medicines Agency (EMA) is to restart a project to update its pharmacovigilance system for veterinary medicines next year. Work on the initiative initially got underway in 2010, only to stop three years later because of budget cuts and difficulties meeting deadlines.

While efforts to update the system to make it more user friendly, add data surveillance capabilities and bring it in line with Veterinary International Cooperation on Harmonisation (VICH) guidelines have been on hold for two years, the need for these changes has never gone away. EMA has now reached a point at which it thinks it has the resources to finally roll out the improvements. The project is set to restart next year, with the bulk of development getting underway in 2017.

As well as the aforementioned changes EMA was working on when the project first began, the resumed initiative will also address the software that underpins EudraVigilance Veterinary. The changes to the software are one way in which the veterinary project is responding to the evolution of the system of pharmacovigilance for human medicines. Work on updates to the software used in EudraVigilance Human is already underway.

Once the software update is complete, the veterinary system will share many of the capabilities of the human pharmacovigilance model. This will entail giving marketing authorization holders (MAHs) greater, more direct access to support enhancements to data analysis. For now, MAHs can continue as normal. The reporting requirements of the existing system are still in place, but new capabilities will gradually start to come on line over the coming years.

Status Report

Other News:

EMA has warned that its IT systems will be down from the evening of 30 October to the morning of 3 November. The regulator is taking the action, which will affect EMA’s public website and the systems used to file applications, to allow it to test the IT recovery processes that are in place to help its systems bounce back from a major event. EMA Notice

CHMP has begun a consultation about the ICH paper on the common technical document for the registration of pharmaceuticals. The document is a revised version of a text ICH started work on more than 15 years ago. Changes to the text affect the product development rationale and the benefits and risks conclusions. The consultation period is open until the end of the year. Document

A campaign group has written to the British government to request the issuance of a compulsory license for Roche’s Kadcyla. Such a move would allow companies to begin selling biosimilar copies of Kadcyla, lowering the cost of the medicine. The request follows the rejection of Kadcyla by the National Institute for Health and Care Excellence. Letter, Reuters



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