• 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...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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 ...
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    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...
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    The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1)

    This two-part series on the Southeast Asian regulatory environment for pharmaceuticals describes the regulatory landscape in each of the 10 Association of Southeast Asian Nations (ASEAN) countries and attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets. Part 1 presents information on the larger ASEAN markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietna...
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    AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach

    The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software. The draft version of the document was released in July 2014, and provided a high-level overview of the regulatory approaches taken by major economies--the US, EU, Australia and China—toward the regulation of software as a medical device (SaMD). The overall goal of the white pa...