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  • Regulatory NewsRegulatory News

    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...
  • Feature ArticlesFeature Articles

    EU regulation of herbal products, Part 1: Definitions, regulations, and documentation

    This article compares and contrasts the regulatory requirements for herbal medicinal products, herbal-based medical devices, and botanical food supplements in the EU. It provides an overview of the current framework, highlights areas of controversy, and presents recent regulatory developments. The article is the first of two on this topic. The current article presents the definitions, main regulations, and documentation requirements for placing the products on the market;...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • RoundupsRoundups

    Euro Roundup: HRPA posts 5-year plan as it emerges from ‘twin challenges’ of Brexit and COVID

    Ireland’s Health Products Regulatory Authority (HPRA) has published its strategic plan for 2021 to 2025. HPRA set out five goals intended to help it emerge from the “twin challenges of Brexit and COVID-19” and deliver better outcomes for people and animals.   The five goals are titled health system partnerships, progressive regulation, communication and engagement, enabling innovation and great people, great processes. By engaging in activities that further those goals...
  • RoundupsRoundups

    Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

    The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.   Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisd...
  • ReconRecon

    Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...
  • Feature ArticlesFeature Articles

    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...
  • Regulatory NewsRegulatory News

    Euro Regulatory Roundup: EU health committee calls for EMA to get wider remit, more staff to stop shortages

    A key health committee has called for the European Medicines Agency (EMA) to get a wider remit and an increased headcount to prevent shortages of essential medicines. The European Parliament committee made the request in a report that argues EMA should be made the regulatory authority in charge of preventing shortages.   In recent months, multiple Parliament committees have begun considering how to address the emerging problem of medicine shortages. As the group primar...
  • 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...