• New Submission Format for KASA Regulatory Quality Assessment

    Is it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign. With the discussions, one can clearly make out that the FDA is exploring the positive aspects of...

  • Medical Device Registration Process in USA
    September 27, 2018 Medical Devices

    Currently valued at $156 billion, the USA is the largest market for medical devices in the world representing approximately 40% of the global market. Given the scenario, manufacturers are on constant look out to market their products in the region. Enroute, even a small error in the approach can result a device recall. Therefore, it is necessary for the manufacturer to be at par with the...

  • Value of GxPs (GLP, GCP, GMP) in Global Pharma 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...

  • 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...

  • Outsourcing Artwork Services and its advantages
    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....

  • EMA Revises IDMP 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 Published New Medical Device Classification Catalog
    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...

  • 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...

  • FDA Indications, Usage section of labeling for drug & biological products
    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...

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