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  • Feature ArticlesFeature Articles

    MDR and IVDR: the Potential for a 28-Agency, 22-Language Regulatory Process for Medical Devices in the EU

    The following article represents the views and interpretations of the author and do not necessarily reflect those of RAPS: This article provides detail in the MDR and IVDR which seems to have escaped observation. Yet, the detail could have far-reaching implications. What follows is in both the MDR and IVDR, and so in the pursuit of clarity, all references are restricted to the MDR. Introduction Both the MDR: the EU Medical Device Regulation, 2012/0266 (COD) and ...
  • Regulatory NewsRegulatory News

    ANSM Says Pilot for New Clinical Trials Regulation Enforcement a Success

    France's Agency Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) on Wednesday reported positive results for its year-long pilot for assessing clinical trials using the process established in the new EU Clinical Trials Regulation . Background In 2014, Regulation (EU) No. 536/2014 , known as the new Clinical Trials Regulation , was adopted. The goal of the regulation is to provide faster, more coordinated assessments for clinical trial applications t...
  • Regulatory NewsRegulatory News

    International Generic Drug Regulators Outline Plans for Collaboration Through 2020

    As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years. Strategic priorities for the consortium include establishing a framework for sharing assessment-related information between regulators, promoting convergence of technical and data requirements and increasing the alignment of administrative and regula...
  • Regulatory NewsRegulatory News

    European Commission Clears up Questions on Orphan Drug Regulation

    Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation . The consultation sought to address five issues that have arisen since the Orphan Regulation came into effect in January 2000: Clarifying the meaning of "significant benefit" How to apply the Orphan Regulation to emerging diseases, such as Ebola, that are not present within...
  • Regulatory NewsRegulatory News

    EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report

    The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the  Pediatric Regulation,  ten years after its implementation. The comments on the consultation, which is open until 20 February 2017, will help inform the EC's report, which is expected to be published in 2017 and will assess the regulation's impact on public health and the pharmaceutical industry. Background The Pediatric Regulation, known in the EU ...
  • RAPS' LatestRAPS' Latest

    10 Disruptive Technologies and the Regulatory Implications

    The 2016 Regulatory Convergence will begin with opening keynote remarks from R “Ray” Wang , noted expert on disruptive technologies and new business models . Hearing Wang’s thoughts on innovation and technology and how regulatory can keep up with the rapid changes should prove to be a timely and appropriate way to begin this year’s Convergence. The healthcare products sector has seen the introduction and development of a number of disruptive technologies in ...
  • Regulatory NewsRegulatory News

    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
  • Regulatory NewsRegulatory News

    FDA Declares ‘General Wellness’ Devices Exempt From Regulations

    The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements. Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons." As in the...
  • Regulatory NewsRegulatory News

    EC Report Analyzes Regulatory Frameworks for Advanced Therapies in US, Canada, Japan and Korea

    The European Commission report released Wednesday dissects the similarities in how gene-, cell- and tissue-based advanced therapies are regulated across the four different geographic regions, though ongoing research projects in such therapies are heavily concentrated in the US and Japan. The 327-page report highlights the “high degree of convergence” in the regulation of advanced therapies across the US, Canada, South Korea and Japan, noting that only Japan has enacted (...
  • Regulatory NewsRegulatory News

    Brexit Conundrum: How Does MHRA Work With EMA Moving Forward

    With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent. Not only will the European Medicines Agency (EMA) have to uproot its headquarters from London (presumably shifting more than 600 full-time employees), but the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will have to decide if they want to continue conducting drug manufacturing...
  • Regulatory NewsRegulatory News

    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...
  • Regulatory NewsRegulatory News

    European Parliament Looks to Take Over EMA Fee Process

    The European Parliament has voted to lessen the European Commission’s control of the structure and level of fees charged by the European Medicines Agency (EMA), which may instead be set by members of Parliament and European Union (EU) ministers. The amendment, which was proposed alongside a host of other amendments on fees and EMA-related structures linked to EMA’s founding regulation (No 726/2004), though any changes must be accepted by the EU Council of Ministers. “Me...