Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EMA Starts Consultation on Quality of Inhaled Pharmaceutical Products
The European Medicines Agency (EMA) has started a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. EMA published the concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its current advice in 2006.
Changes to EMA’s position on therapeutic equivalence are the top priority for the concept paper on pharmaceutical quality. EMA has published that concept paper in conjunction with another that deals specifically with how to show the therapeutic equivalence of inhaled treatments of asthma and chronic obstructive pulmonary disease. That second, therapeutic equivalence-focused concept paper is expected to usher in changes that affect EMA’s position on pharmaceutical quality, forcing the regulator to update the two texts in parallel.
In the quality concept paper, officials at EMA’s Quality Working Party outline the need to update the guideline to reflect changes to dose proportionality, flow-rate dependency, stage grouping and other topics.
EMA derived these priorities from its work on the therapeutic equivalence concept paper. That concept paper marks the start of an attempt to adapt a 2009 guideline to reflect the experiences of applicants who have sought to show therapeutic equivalence to an orally inhaled reference product. National competent authorities have received several such filings since the guideline was last updated.
The new guideline will describe a stepwise process to demonstrate equivalence that goes from in vitro studies, to pharmacokinetic tests and on to pharmacodynamic and clinical safety and efficacy trials. Recognizing that showing therapeutic equivalence using in vitro and pharmacodynamic data is difficult, EMA wants the guideline to reflect the relative benefits of pharmacokinetic studies.
EMA is also using the updates of the two guidelines as an opportunity to address other issues. Topics up for discussion in the therapeutic equivalence text include advances in metered dose inhalers and dry powder inhalers. In addition to therapeutic equivalence, the agency plans to look at abbreviated methods for determining aerodynamic particle size distribution, tests of delivered dose uniformity, lifecycle management and other topics when it starts work on revising the quality guidance.
The quality concept paper is open for comment until the end of June. EMA will close the comment period on the therapeutic equivalence text at the end of May.
Concept Paper, More
EMA Proposes Process for Collecting Standardized Data on Antimicrobial use
EMA has released draft guidelines on the provision of data on antimicrobial use in animals. Publication of the draft begins the process of standardizing the data member states gather and share with EMA on the use of antimicrobials in animals in their jurisdictions.
The agency indicated its interest in developing guidelines on the topic when it reported on a European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) trial in May. That trial collected data on the use of antimicrobials in pigs. EMA found collecting the data “challenging” and noted the flaws of the trial’s use of two denominators, namely the number of pigs produced and number of pigs present on the farm. The regulator felt a standardized denominator was needed to enable comparisons of antimicrobial use across the European Union.
Having expressed dissatisfaction with both denominators used in the trial, EMA is proposing a new measure in the draft guideline. The text defines denominator as the “estimated animal biomass at risk of being treated with antimicrobials.” EMA wants people to calculate the estimated biomass for each species by multiplying the number of animals by its standardized weights. A farm breeding pigs for slaughter, for example, would multiply the number of pigs by 65.
The denominator is one of many subjects covered in the 36-page document. The draft guideline also discusses the data to be provided to EMA and the frequency with which they must be shared. EMA is proposing a flexible attitude to some of these topics. For example, the regulator plans to let member states decide how often they provide data.
EMA has moved quickly to get the guidance out for comment. ESVAC agreed on the draft on 23 March and adopted it for consultation the same day. The text was released for consultation on 24 March. This is a tighter than typical timeline. If different committees and working parties are involved, months can pass between a draft being agreed upon and adopted. Gaps between adoption and the start of a consultation can last more than one week.
The antimicrobial guideline is open for comment until 24 September.
Animal Health Industry Raises Concerns with Pharmacovigilance Reporting Timelines
IFAH-Europe has raised concerns about proposed pharmacovigilance reporting timelines for veterinary medicines. The animal health trade group prefers the 30-day timeframe put forward originally by the European Commission to the variable window now being considered.
As Tony Simon, an IFAH-Europe representative and director of pharmacovigilance and scientific affairs at Zoetis, said at EMA Veterinary Medicines Info Day this month, the commission proposed 30 days as the standard timeframe for adverse event reporting when it drafted legislation in 2014. Marketing authorization holders (MAHs) and competent authorities would each have 30 days after learning of an adverse event to update the pharmacovigilance database.
The European Parliament proposed changing the timeframes, a suggestion Simon said makes the system more complicated. In its amendments, Parliament suggested giving competent authorities 15 days to add reports to the database. When dealing with serious adverse events, MAHs would also have 15 days. For less serious events, Parliament suggested giving MAHs 42 days.
Concerns about the proposed changes were one of several points made by Simon during his presentation. Simon also questioned the practicality of making MAHs communicate “potential signs of antimicrobial resistance.”
IFAH Presentation, Parliament Amendments
EMA Creates Task Force to Further Use Big Data in Medicine Assessments
EMA has created a task force to establish a roadmap and recommendations about the use of big data in medicine assessment. The regulator has joined with the Heads of Medicines Agencies (HMA) to look into the topic, starting by mapping the source and characteristics of big data.
HMA and EMA have put the Danish Medicines Agency in charge of the task force and rounded up regulatory staff from across the European Union to sit on the committee. The overarching goal is to assess how regulators can use large datasets to inform benefit-risk assessments throughout the lifecycles of products, while avoiding data protection problems and other pitfalls.
To break the topic down, the task force has chosen a selection of actions to work on over its first 18 months. In this period, the task force plans to map the sources and characteristics of big data and explore how such datasets could affect medicines regulation. The goal is to emerge with a list of recommended changes to legislation, guidelines and data security rules.
Other near-term objectives include the creation of a roadmap plotting out the development of ways of using big data in evaluations of regulatory filings. The task force will also look to collaborate with regulators based outside the region during this period.
Press Release, More
Other News: EMA
has added a new section to its EudraVigilance question and answer document. The new questions deal with updating organization categories. Q&A