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  • Feature ArticlesFeature Articles

    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
  • Regulatory NewsRegulatory News

    New priorities set for trans-Atlantic collaboration on medicines

    As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.   “In the context of the  COVID-19 pandemic , the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in...
  • Regulatory NewsRegulatory News

    Biopharma industry urges MRA to mitigate risk of no-deal Brexit

    The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.   In a letter to senior EU officials, the six trade groups call for Brexit negotiators to pr...
  • Regulatory NewsRegulatory News

    WHO issues guidance for prequalified products amid COVID-19

    The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of ...
  • Feature ArticlesFeature Articles

    Outsourcing in regulatory operations

    This case study explains Project BRIDGE and its vision to centralize process and services, such as dossier planning, compilation and publishing, submission, tracking and archiving to efficiently ensure compliance, increase transparency and maintain or improve quality of submissions to global health authorities. Introduction The author began employment at Boehringer Ingelheim, a large global pharmaceutical company with headquarters in Germany in October 2014. At that ti...
  • RoundupsRoundups

    EU Regulatory Roundup: Denmark permits remote SDV during pandemic

    Extraordinary measures guidance from the Danish Medicines Agency (DKMA) now has been updated to allow remote source data verification (SDV) for certain clinical trials during the COVID-19 pandemic.   Remote SDV enables sponsors to verify data without sending a clinical research associate to a clinical trial site, making it an attractive option at a time when contract research organizations are reporting limited in-person access to study centers. Despite that, the first...
  • Feature ArticlesFeature Articles

    New claims under EU MDR and EU IVDR

    This article discusses medical device promotional and advertising product claims under Article 7 of the European Union’s new Medical Devices Regulation ( EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) and examines how and when product claims are misleading or false as defined under the regulations. Introduction    Article 7 of the EU MD R 1 and EU IVDR 2 provide new claims regulations for medical devices. All of the requirements relate ...
  • Feature ArticlesFeature Articles

    Preparing for EU MDR translation

    This article discusses what medical device manufacturers need to know about product information language translation as required by European Medical Devices Regulation ( EU MDR ). The author addresses how companies can better meet the regulation’s language component requirements and offers suggestions ranging from being aware of who the information reading audience is and hiring professional translators.   Introduction   The complex regulatory requirements for EU ...
  • Regulatory NewsRegulatory News

    COVID-19 IVD quality problems drive EC guidelines

    A “mismatch” between the expected and actual quality of coronavirus (COVID-19) tests has spurred new guidelines from the European Commission (EC). The guidelines are part of a roadmap to lifting the lockdown measures implemented to curb the spread of the disease across the European Union, according to an EC statement dated 15 April.   Governments across the European Union (EU) are working to step up testing capacity, recognizing that testing will play a key role in e...
  • Regulatory NewsRegulatory News

    COVID-19: FDA, EMA and 16 drugmakers take part in development effort

    The National Institutes of Health (NIH) on Friday announced a new initiative to accelerate the development of treatments and vaccines for coronavirus disease (COVID-19) involving the US Food and Drug Administration (FDA) and other US health agencies, the European Medicines Agency (EMA) and 16 drugmakers.   The goal of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will be to develop a coordinated research strategy to prioritize dru...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA shares advice on validated computerized systems used in clinical trials   The European Medicines Agency (EMA) has published a notice about validating and qualifying all types of computerized systems used in clinical trials. EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and accep...
  • Regulatory NewsRegulatory News

    FDA, EC offer guidance on COVID-19 convalescent plasma

    The US Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19. FDA’s 9-page guidance, which follows the agency’s granting of the use of single patient emergency Investigational New Drug Applications (eINDs) to the investigational plasma, is meant to provide recommendations to health care pr...