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  • Regulatory NewsRegulatory News

    ICH Genomic Sampling Guidance: FDA Begins Consultation

    The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling. Specifically, the guideline, E18 Genomic Sampling and Management of Genomic Data , seeks to create uniform standards for collecting, storing and handling genomic samples used in clinical trials. According to ICH, the guideline "will clarify points to consider ...
  • Regulatory NewsRegulatory News

    EU Proposes More Structured Convergence With FDA on Pharma Regulations

    The European Union has offered a new proposal that would further harmonize the pharmaceutical regulations between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), which could speed new drug approvals and manufacturing inspections in both regions. The seven-page proposal, released ahead of Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US, would create a specific annex in those trade talks o...
  • Regulatory NewsRegulatory News

    Former FDA and NIH Heads Call for Regulatory Harmonization

    Former US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and former National Institutes of Health (NIH) Director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine . The call comes as nearly 40% of drugs and half of all medical devices used in the US are made elsewhere, while 80% of the active pharmaceutical ingredients in US drugs are manufactured in f...
  • Regulatory NewsRegulatory News

    ICH Looks to Global Expansion

    The newly renamed International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is looking to bring more pharmaceutical and medical device regulators into its ranks as members and observers. Begun in 1990 by EU, US and Japanese regulators as a way to further harmonize regulations on safety, efficacy, quality and data standards across the globe, with progress in developing more than 80 guidelines on such topics , as well as wor...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Dengue Vaccine Nears Approval in India Without Local Phase III Data (19 January 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Sanofi Secures Indian Committee Approval for Dengue Vaccine Without Local Phase III Data An Indian drug regulatory committee has recommended allowing Sanofi to bring its Dengue vaccine to market without first generating Phase III data in a local trial. The committee thinks the divergence from normal protocol is acceptable given the scale of the health threat posed by the D...
  • Regulatory NewsRegulatory News

    IMDRF Participants Outline Plans for Next Week’s Meeting in Japan

    In anticipation of the International Medical Device Regulators Forum (IMDRF) stakeholders meeting in Japan next week, participating countries’ regulators, trade groups and others have outlined a number of updates they plan to share. Background Begun in 2011, IMDRF is a voluntary group of medical device regulators from Australia, Brazil, Canada, China, EU, Japan and the US, as well as the World Health Organization (WHO), with the aim of accelerating international medical...
  • Feature ArticlesFeature Articles

    Harmonization Creates Opportunities for Both Regulatory Professionals and Agencies in Developing Countries

    This article discusses how the regulatory profession in developing countries can benefit from global regulatory harmonization. Advances in science and technology in the global healthcare industry continue to impact millions of people by providing them—often for the first time—with medication necessary to prevent early death, serious illnesses or irreversible disabilities. Scientific discoveries of new therapies and inventions, particularly in drug delivery (e.g., ...
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    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 ...
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    ICH Takes Step Toward New eCTD Version

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD). ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003. Background ICH was formed followin...
  • Feature ArticlesFeature Articles

    Out of Africa: Six Regulatory Articles that Span the Continent

    Africa has a rapidly growing populace and demand for safe, effective and trusted medical products. Different geographic areas of Africa are developing their medical products submission and approval systems at varying rates of sophistication dependent, in part, on internal resources. Exclusively for RAPS members comes this valuable collection of articles exploring important regulatory differences in five major geographic/economic regions of Africa: East and Southe...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA Adopts International Photosafety Testing Standard

    New guidance published by the US Food and Drug Administration (FDA) would bring the US into alignment with an international standard meant to ensure new drug products don't cause photosensitivity in patients. The standard, S10 – Photosafety Evaluation of Pharmaceuticals , was developed by the International Conference on Harmonisation (ICH), an international body composed of FDA, the European Medicines Agency (EMA), Japan's Pharmaceutical and Medical Device Agency (PMD...