Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively.
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May 20, 2022 Publishing & Submissions, Health Authority Updates -
April 27, 2022 Regulatory Affairs, Publishing & Submissions, Regulatory Software & ServicesFor years, Regulatory publishing was done by manual tasks. Publishers used to work for hours formatting documents, generating Agency-compliant PDFs, performing quality checks, compiling documents for submissions, and troubleshooting issues related to submissions.
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April 4, 2022 Pharmaceuticals, Publishing & Submissions, Health Authority UpdatesThe ever-increasing demand for various channels to share information and engage with customers poses numerous challenges in the pharmaceutical industry. Such engagement comes with risks, particularly in the advertising domain. To ensure accurate and good practice, Health Canada regulates the advertising or promotional material before its dissemination in Canada.
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December 15, 2021 Publishing & Submissions, Regulatory Software & ServicesThe world of Life Sciences is ever-changing and becoming more challenging, with fast-paced Regulatory guidelines being introduced frequently. Over the last decade, Health Authority (HA) guidelines have seen a manifold increase. In the current scenario, companies must adopt smart, modular & intelligent solutions in developing products to ensure global market reach and compliance.
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December 15, 2021 Regulatory Affairs, Publishing & Submissions, Health Authority UpdatesMarketing Authorization Holders (MAHs) in the United Kingdom were provided and asked to submit any/all data and related information for all converted licenses in the electronic Common Technical Document (eCTD) format within just one (01) year starting from January 01, 2021.
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October 26, 2021 Pharmaceuticals, Regulatory Affairs, Publishing & SubmissionsChina has established its position as a manufacturing hub for pharmaceuticals. Innovation in manufacturing techniques has encouraged China to explore the scope of research and development for medicinal preparations.
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September 16, 2021 Publishing & Submissions, Regulatory Software & ServicesAs many of the Health Authorities transitioned from paper documentation format to the eCTD format, it is time for organizations to define key measures to submit documents in the electronic format to remain compliant.
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May 11, 2021 Regulatory Affairs, Publishing & SubmissionsThe withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc.
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May 7, 2021 Publishing & Submissions, Regulatory Software & ServicesOn-time Regulatory submission is the key to achieve quick time-to-market. But, with a lack of planning, the industry could face a lot of complications which may result in rejected submissions, delayed market-entry, increased costs due to extended timelines.
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November 18, 2020 Regulatory Affairs, Publishing & Submissions, Regulatory Software & ServicesStructured Product Labeling (SPL) and Structure Product Monograph (SPM) are the mandatory document mark-up standards for the submission of label content, product and facility information and any subsequent changes to the existing label information in an electronic format.