• RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
  • Regulatory NewsRegulatory News

    European Commission kicks off review of pharmaceutical legislation

    As part of its broader pharmaceutical strategy, the European Commission on Tuesday released a roadmap for its planned revision of the EU’s aging pharmaceutical legislation next year.   The Commission adopted its pharmaceutical strategy last November following a public consultation earlier in the year. “[The strategy] is intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant,” the Commission writes. (RELATED: European C...
  • Regulatory NewsRegulatory News

    European Commission tightens requirements for duplicate MAAs

    The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after launching a targeted consultation on the practice.   While the notice still foresees an increase in the number of requests for duplicate MAAs, the Commission has closed off the ability of companies to request duplicate MAAs solely to introduce a first generic to their own ...
  • Regulatory NewsRegulatory News

    EC advances amendment to speed adapted COVID vaccines

    The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.   “We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursu...
  • Regulatory NewsRegulatory News

    MDCG issues guidance on Eudamed alternatives

    The European Commission’s Medical Device Coordination Group (MDCG) last week issued guidance on administrative practices and alternative technical solutions on the application of certain Medical Device Regulation (MDR) provisions in the absence of a fully functional Eudamed system.   While the first of six Eudamed modules was made available late last year, the remaining modules are expected to be rolled out by the database’s May 2022 date of application. Some modules, ...
  • Regulatory NewsRegulatory News

    EU regulators expand use of remote source data verification in clinical trials

    The latest update to the European Commission and European Medicines Agency’s guidance on managing clinical trials conducted during the COVID-19 pandemic expands the use and scope of remote source data verification (rSDV) in clinical trials.   Previous versions of the guidance envisioned that rSDV would “only be considered necessary for very few trials” involving the treatment or prevention of COVID-19, “Or in the final data cleaning steps before database lock in pivota...
  • Regulatory NewsRegulatory News

    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • Regulatory NewsRegulatory News

    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    Bespoke therapies – opportunities, challenges, and hope

    This article discusses the advent of bespoke therapies, defined as the tailoring of medical treatment to the individual characteristics or symptoms and responses of a patient during all stages of care and as a new frontier beyond personalized medicine. The author covers the revolutionary genetic tools implementing such therapies and the clinical and nonclinical safety perspectives for bespoke therapies. The author concludes that with bespoke therapies we are entering a new...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...