• Generics: FDA’s Record for Approvals and The New Guidance Drafts
    October 30, 2018 Pharmaceutical

    Do you know? The United States Food and Drugs Administration (US FDA) has yet again set a new record for the number of generic drug approvals. In comparison to FY 2017’s 937 approvals, FDA has approved a total of 971 generic drugs, so far this year which includes 781 final approvals and 190 tentative approvals. Out of the total approvals in this year, 12% were for complex...

  • Regulatory Affairs: A Lifeline for Life Sciences
    October 22, 2018 Regulatory Affairs

    In the current competitive landscape of Life Sciences, it is required to reduce the time-to-market for a quick product launch to take advantage of early success. For the same, manufacturers should ensure that all Regulatory aspects are adhered within the submission deadlines for successful approvals. If any observation is found by respective Health Authority in this entire process, it may lead...

  • USFDA guidance on Post-Approval Changes to Drug Substances
    October 4, 2018 Regulatory Affairs

    Any modification to the drug substance manufacturing process such as facility / equipment changes, synthetic route changes etc. has the potential to affect the final drug product’s quality / efficacy / safety. To avoid such risks and keep the industry informed about the best practices, as part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA II), the United States Food and...

  • 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...

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