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    EC updates Clinical Trial Regulation Q&As ahead of January go-live

    The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.   The revision clarifies that active pharmaceutical ingredients (APIs) used in investigational medical products do not have to comply with good manufacturing practices (GMPs) in the clinical trial application, describes the content of the protocol synopsis, and adds a new question o...
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    EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance

    The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.   Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science S...
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    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
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    EMA readies CTIS go-live plan

    A new electronic information system for clinical trial reporting in the EU is one step closer to launch with the European Medicines Agency’s (EMA’s) Thursday publication of a go-live planning document.   The 12-page document covers key steps remaining before the launch of the Clinical Trial Information System (CTIS), planned for 31 January 2022, and follows an April 2021 audit by EMA’s management board that confirmed that CTIS is “fully functional and meets the agreed ...
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    New MDCG guidance shows how devices fit into MDR’s classification rules

    The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.   Under the MDR , which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.  Annex VIII of the...
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    New guide to clinical trial lay summaries available for EU sponsors

    The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.   The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the develop...
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    Challenges and opportunities in medical device clinical trials in Europe

    In mid-2021, a survey was launched to evaluate where European medical device manufacturers and pharmaceutical companies see the greatest challenges in clinical trials and which trends they envision in this area in coming years. The top challenges included lack of personnel, time investments, complexity of the study protocol, the identification of suitable subjects, and data analysis and publication. Although most participants had not yet conducted decentralized trials, mor...
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    Vaccines Europe makes the case for vaccine-specific HTA

    A new position paper from Vaccines Europe calls for an EU-wide committee and effort to implement clinical health technology assessment (HTA) methodologies that are specific to vaccines.   The vaccine-specific initiative would be part of a broader effort by the European Commission (EC) to institute common HTA methodologies and tools throughout the EU. Vaccines Europe, together with the European Federation of Pharmaceutical Industries and Associations’ (EFPIA), is seekin...
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    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...
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    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Convergence: EMA study reveals need for RWE framework, submission structure

    The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...
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    Convergence: Regulatory considerations in advancing gene and cellular therapies

    When developing a regulatory submission for a gene or cellular therapy, it’s essential to keep the basics in mind, such as how to demonstrate the product’s identity, purity, and potency, Haroon Hashmi, PhD, told attendees at RAPS Convergence 2021.   “Even when we think about these complex technologies -- new emerging technologies -- certain regulatory principles always stay in place,” said Hashmi, senior vice president at Ziopharm Oncology, which has developed the Slee...