• The Value of GxPs in Global Product Launch

    Over the decades, with the inception of strict Regulatory regimes, life sciences companies have launched numerous medicinal products in the market prioritizing the end user’s safety. But only few have remained popular sustaining the market competition while many fail to break the initial Regulatory barriers because of incompliant practices. To attain Regulatory compliance and expedite the...

  • TGA Mandates Electronic Procedure for Certificate of Free Sale or Export Certificate
    September 17, 2018 Medical Devices

    According to a recent announcement by the Therapeutic Goods Administration (TGA), sponsors of medical devices have a new procedure to follow for certificate of free sale or export certificate. The new application format allows the sponsors to submit their applications and receive the certificates electronically without any hassle and delays. The change in process is in response to the issues...

  • Artwork: Is Opting For “Managed Services” The Right Option?
    September 10, 2018 Artwork Pack Management

    Packaging, labeling and “artwork” are crucial stages of a drug product lifecycle, as they are the main safety information sources for the end user. Any mislead in these processes may lead to product recalls. Hence, it is highly important for a manufacturer to contemplate all possible approaches to successfully implement them either in-house or by opting managed services i.e. to contract out....

  • ISO Revises Implementation Guidelines for ISO 11238
    September 5, 2018 Pharmaceutical

    As the Brexit transformation and transitions are in full pace, the European Medicines Agency (EMA) is firm on releasing periodical updates for implementation of the Identification of Medicinal Products (IDMP). Stepping in that direction, the International Organization for Standardization (ISO) has recently updated the ISO/TS 19844...

  • 4 Key Aspects to Register/Notify Cosmetics in Brazil

    Brazil’s cosmetic market is flourishing, showing no signs of slowdown even in the economic fluctuations. In Brazil, cosmetics in various segments such as organic, skincare, haircare, etc. are gaining popularity among users, and their market extent is increasing day by day. It is the responsibility of National Agency of Health Surveillance (ANVISA), functioning under the Ministry of Health, to...

  • CFDA Mandates New Classification Catalog for Medical Devices
    August 21, 2018 Medical Devices

    On August 1, 2018, China Food and Drug Administration (CFDA) - the Chinese health authority, has taken a major step towards classification of medical devices to be marketed or currently being marketed in China. The CFDA has officially published and mandated the new Medical Device Classification Catalog. To be on par with continuous changes in regulations for medical devices and considering the...

  • Biosimilars in Europe and The USA: Decode Market and Regulatory Scenarios
    August 13, 2018 Pharmaceutical

    Biosimilars, which are viewed as supplements for their equivalent biologicals in terms of safety, quality and efficacy (if & when proved), are opined as value gainers in the days to come. An external survey predicts an exceptional surge in demand for these products whose value is expected to rise significantly by 2020. With many high-value petitions of biological products nearing their...

  • Indications and Usage Section of Labeling
    July 30, 2018 Regulatory Labeling

    Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions. To avoid such adversities, the United States Food and Drug Administration (US FDA) has released a draft guidance of Indications and Usage section of labeling...

  • TGA Mandates eCTD V3.1 Module 1 Specification Decode the Deadline and Section-wise Updates

    Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region. Therapeutic Goods Administration (TGA) of Australia has rolled out a new mandate to use latest version 3.1 Module 1 Specification for...

  • New EU MDR - Timelines and Renewed Documentation Requirements
    June 1, 2018 Medical Devices

    On April 5, 2017, the European Commission has approved the new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR, which have come to effect in force (EIF) from May 25, 2017.

    The primary reason to revamp the preceding medical device directives (MDD) was aimed at enhancing compliance standards for the device manufacturers, notified bodies (NBs) and other stakeholders. As...

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