RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    EMA addresses use of registry-based studies

    The European Medicines Agency (EMA) has issued a new guideline on registry-based studies, giving detailed advice for use of patient registries in both the pre- and post-authorization phases for medicinal products.    After committee approval and a consultation period with the EU Regulatory Network, the guideline has been released for public consultation, with comments due before the end of 2020.   The guideline’s focus is on the use of patient registries for studie...
  • Regulatory NewsRegulatory News

    EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

    The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q3D(R2) guideline on elemental impurities.   EMA also endorsed the use of dexamethasone to treat coronavirus disease (COVID-19) patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial.   “Published data from the RECOVERY study show that, in...
  • Regulatory NewsRegulatory News

    Convergence: Global planning is key to successful development of companion diagnostics

    Planning and alignment are the keys to successfully steering companion diagnostics through regulatory processes across the globe, according to experts who spoke at RAPS Convergence 2020.   “The most critical way to develop a companion diagnostic is really a coordinated, co-development model, and this is the most effective path to regulatory approval,” said Ken Butz, associate director of regulatory technical advisors at PPD, and the leader of a session on the evolving ...
  • Regulatory NewsRegulatory News

    Convergence: EMA close to finalizing guidance for advanced therapies

    The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies. The “Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells” was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to...
  • Regulatory NewsRegulatory News

    EMA to require clinical data publication for COVID-19 related products

    The European Medicines Agency (EMA) this week announced it will require drugmakers to publish clinical data for medicines and vaccines authorized to treat or prevent coronavirus disease (COVID-19) as part of its exceptional transparency measures during the pandemic.   After spending years implanting its policy for proactively publishing clinical data for products submitted to the agency for review, EMA suspended the publication requirement in August 2018 to focus on ...
  • Regulatory NewsRegulatory News

    Medical cannabis regulation is a global patchwork

    (Editor's note: this article was updated to clarify which products made from cannabis or hemp plants fall under Health Canada's Natural Health Products category.) The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals are likely under any scenario.   “It’s currently a complex patchwork of approaches,” Michael Craig, a principal consultant at Pa...
  • Regulatory NewsRegulatory News

    Embracing disruption: Convergence plenary stresses compassion, innovation

    The COVID-19 pandemic has turned daily life upside down around the globe and presented unique challenges for regulatory affairs professionals. In the kickoff plenary session of RAPS 2020 Convergence, regulatory experts and business leaders shared how they have coped with the unprecedented disruption and offered insights about how the pandemic may be accelerating industry-wide changes. The conversations were facilitated by Kimberly Belsky, vice chair for Convergence and ...
  • Regulatory NewsRegulatory News

    EMA recommends pulling ulipristal acetate for fibroids

    An oral treatment for uterine fibroids should have its European Union marketing authorization revoked, according to the safety committee of the European Medicines Agency (EMA).   Citing the possibility of serious liver injury from ulipristal acetate, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the revocation of marketing authority for the 5 mg oral tablets, which are marketed as Esmya and generics. The medication was authorized in the EU to tre...
  • Regulatory NewsRegulatory News

    EMA finalizes pediatric trial preparedness framework

    The European Medicines Agency (EMA) has released the final version of a framework for pediatric clinical trial preparedness. The final document aims to “increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan within which a trial is embedded,” according to EMA.   This framework’s releas...
  • 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 goes all-virtual for remainder of 2020

    The European Medicines Agency (EMA) has announced that all its committee and working party meetings will be held virtually through the end of 2020.  Stakeholder events will also be virtual through the end of the year as well, although a few events will have an in-person speaker panel.   “EMA has taken steps to reduce the further spread of COVID-19, with the aim of protecting staff, delegates and experts and playing our part as responsible citizens in our host country, ...
  • Regulatory NewsRegulatory News

    EMA addresses risk evaluation, mitigation for nitrosamines

    An updated question-and-answer document from the European Medicines Agency (EMA) provides guidance on handling nitrosamine impurity testing for marketing authorization holders.   Marketing authorization holders (MAHs) are to perform a risk evaluation to ascertain whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by 31 March 2021. Products containing biological APIs should undergo this first step in risk eval...