• RAPS' LatestRAPS' Latest

    RAPS' New European Council Set to Shape and Support the Regulatory Profession

    • 19 October 2017
    RAPS is stepping up its presence in Europe and supporting its European expansion with the launch of its first ever RAPS European Council (REC). Following the announcement that RAPS plans to invest more than 2 million euro over the next three years to implement its growth plan in Europe, the new European Council will support RAPS’ growing member base and volunteer network across Europe with the information and education they need not only to ensure compliance with...
  • Regulatory NewsRegulatory News

    EMA Crafts New Framework to Better Collaborate With Academia

    As part of efforts to increase academia’s engagement and trust in the regulatory system, the European Medicines Agency (EMA) on Monday announced a new formal framework to better structure interactions between academia and the agency. The  framework  and action plan for the next three years were adopted by EMA’s Management Board in March and feature new ways to evaluate academic entities interested in regulatory activities, build on the available expertise to keep pace...
  • Regulatory NewsRegulatory News

    Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics

    In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted. The 49-page brief comes as the Supreme Court will hear oral arguments on 26 April over a dispute between Novartis’ ...
  • Regulatory NewsRegulatory News

    Ethical Guidelines for Human Research Revised

    The Council for International Organizations of Medical Sciences (CIOMS) last week finalized the latest revision to its ethical guidelines for health research involving human participants. According to CIOMS, the revision aims to address challenges and shortcomings with the previous revision from 2002, especially related to value and fairness of research involving human subjects. In 1982, CIOMS released its first set of guidelines aimed at creating a set of international...
  • Regulatory NewsRegulatory News

    ICH Looks to Revamp GCP Guidelines, Adds New Members

    Members of the International Council for Harmonisation (ICH) agreed on several moves that would revamp the organization's good clinical practice (GCP) guidelines during a meeting in Osaka, Japan last week. Following discussions, ICH said it plans to conduct a broad review of its guidelines related to GCP and clinical trial design, beginning with a reflection paper expected in early 2017. "This will include updating current guidance on interventional trials and expand on...
  • 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...
  • Regulatory NewsRegulatory News

    NIH, FDA Release Streamlined Clinical Trial Protocol Template

    In an effort to increase the efficiency of clinical trial protocol reviews, the National Institutes of Health (NIH) has released a draft protocol template developed in collaboration with the US Food and Drug Administration (FDA). The draft protocol, developed by the NIH-FDA Joint Leadership Council (JLC), will apply to NIH-funded Phase II and III clinical trials done in support of an investigational new drug application (IND) or investigational device exemption (IDE). T...
  • Regulatory NewsRegulatory News

    FDA, NIH Unveil Glossary of Clinical Definitions

    A joint US Food and Drug Administration (FDA), National Institutes of Health (NIH) Leadership Council has released a glossary of definitions, meant to clarify and describe some of the relationships, connections and distinctions among terms used in translational science and medical product development. The council’s development of the glossary is part of the first phase of its BEST (Biomarkers, Endpoints, and other Tools) Resource and aims to capture differences between b...
  • Regulatory NewsRegulatory News

    A Step Forward for New EU Medical Device Legislation

    After weeks of heightened speculation, the European Council has agreed on its approach to new medical devices and in vitro diagnostics (IVD) legislation. Background Regulators in Europe have been discussing the need to reform the legislative framework for medical devices and IVD for many years. In the EU, the legislative process is structured so that only the EC can initiate new legislation. The European Parliament then votes on the commission's proposal and legisl...
  • Regulatory NewsRegulatory News

    FDA, Health Canada Continue Efforts to Promote Regulatory Cooperation

    US and Canadian healthcare product regulators are continuing to move forward in a joint effort to harmonize the way in which both countries regulate pharmaceuticals, medical devices, biological products and veterinary drugs. Background The effort, known as the US-Canada Regulatory Cooperation Council (RCC), was started in 2011 in the hopes of increasing regulatory cooperation and eliminating economic barriers to doing business between (and in) the two countries. The ...
  • RAPS' LatestRAPS' Latest

    Regulatory Profession a Promising Field in China, Says RAPS China Advisory Committee Member Lin

    The following article was adapted from a translation of the original interview conducted in Chinese.  Two decades ago, unlike many of her contemporaries, Linda Lin decided not to pursue a job that would have been a more traditional choice for a woman in China, a job like teacher for example, to work in a joint-venture pharmaceutical factory in Guangzhou. Today, she is vice president of international business for Shanghai MicroPort Medical (Group) Co. Ltd. She also serv...
  • Feature ArticlesFeature Articles

    South Africa Medicines Regulatory System Overview

    South Africa’s medicines’ regulatory submission process is well governed, and there are numerous guidelines available, many following EU standards. The pharmaceutical regulating body in South Africa, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals (See Table 1 for MCC contact information). In ...