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  • Regulatory NewsRegulatory News

    European Commission reviews impact of orphan, pediatric regulations

    The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.   The more than 100-page evaluation reviews the positive impacts and shortcomings of the orphan regulation, Regulation (EC) No 141/2000 , and the pediatric regulation, Regulation (EC) No 1901/2006 , based on external studies and var...
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    EC Offers New Site Suitability Template Under Incoming Clinical Trial Regulation

    The European Commission (EC) on Tuesday published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which has yet to take effect. The template was developed and endorsed by the EU Clinical Trials Expert Group on 9 October to comply with the new regulation, known as Regulation (EU) No. 536/2014 Clinical Trials on Medicinal Products for Human Use. “However, this templat...
  • Feature ArticlesFeature Articles

    Resolving Gene Editing Technology's Ethical and Regulatory Challenges

    This article provides an overview of biomedical applications of gene editing technology, addresses ethical and regulatory challenges associated with its implementation for therapeutic development, and proposes approaches for overcoming these challenges. Introduction Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technology is a genetic "editing" tool aimed at altering DNA sequences and modifying gene function. It offers promising opportunities for ...
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    IGDRP Offers Guidance for Quality Assessors on Drug Substances

    The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances. Initially drafted by regulators from Australia, Canada, Singapore and Switzerland, the document provides assistance to quality assessors in reviewing the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug...
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    Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate

    At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries. Specifically, the hearing focused on CRISPR/Cas9, which is a gene editing tool that scientists can use to quickly and accurately edit DNA in a variety of applications. While there are curr...
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    EU Pediatric Regulation’s 10-Year Anniversary Report Highlights Shortcomings

    Ten years ago, the European Commission created a new regulation as part of an effort to try to encourage more pediatric research. But in the years since, companies have been slow to increase their development of treatments for pediatric populations, particularly in oncology, where many of the medicines used were developed in the 1990s, “if they exist at all,” an EC report released Thursday said. The report highlighted that the number of completed pediatric investig...
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    European Commission Adopts Two Acts on GMPs for Medicines

    Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use. One of the acts is an  implementing directive  that sets out principles and guidelines of GMP in medicines where the manufacture or import is subject to a manufacturing authorization ( see Article 40 of the Community code Directive (2001/83/EC) ). The ...
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    Regulating CRISPR: FDA and Industry Offer Perspective

    Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators. What is CRISPR? According to the Broad Institute , CRISPR (pronounced "crisper") stands for Clustered Regularly Interspaced Short Palindromic Repeats, which form the basis for a genome ...
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    Application of EU Clinical Trial Regulation Delayed to 2019

    The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed. "Due to these delays, the EU  Clinical Trial Regulation  will now come into application in 2019 instead of October 2018, as previously scheduled," EMA said Friday. The agency says it will provide an update at the next meeting of the Management Board in October 2017, followi...
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    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...
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    Australia Considers Allowing the Marketing of Devices Approved Overseas

    Australia’s Therapeutic Goods Administration (TGA) on Monday released a proposal to allow for the use of devices that have received marketing approvals from select foreign authorities. TGA says its primary objective in releasing the proposal is to either: Use approvals from comparable overseas regulators as the evidence of regulatory compliance for including devices in the Australian Register of Therapeutic Goods (ARTG) (and to avoid the need for duplicate assessments...
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    FDA Officials Discuss Modernizing the Regulation of Combo Products

    As one-third of all medical products under development are combination products (meaning a combination of a drug, device or biologic), the US Food and Drug Administration (FDA) is undertaking the tricky task of modernizing the agency’s regulations around these products, which often present unique questions on risks and benefits, two FDA officials wrote in a recent commentary in Nature . Nina Hunter, FDA’s associate director for science policy, and Rachel Sherman, F...