The 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 11, 2021 Regulatory Affairs, Publishing & Submissions -
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.
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October 5, 2020 Pharmaceuticals, Regulatory Affairs, Publishing & SubmissionsAccording to the US Food and Drug Administration (FDA), a majority of prescribed pediatric drugs are not tested. To overcome serious shortage of pediatric drug testing, FDA has issued a final guidance that offers a comprehensive framework for planning and submission of applications for pediatric trials.
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May 6, 2020 Regulatory Affairs, Publishing & SubmissionsThe COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers.
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February 28, 2020 Regulatory Affairs, Publishing & SubmissionsBeing a Member State of the European Union (EU), the Republic of Cyprus through the Department of Pharmaceutical Services has mandated the submission of the medicinal products for human use through the Common European Submission Platform (CESP).
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February 27, 2020 Publishing & SubmissionsOn August 3, 2017, the committee of the Eurasian Economic Union (EAEU) published the standards for electronic submissions of drug applications. With respect to same, the Board of the Eurasian Economic Union released two important ‘Decisions’ on the electronic submission format, which mandates the applicants to provide more detailed information.
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January 29, 2020 Medical Devices, Publishing & SubmissionsThe United States Food and Drug Administration (USFDA), to enhance the submission process for medical devices, has introduced a final rule to replace the paper submissions with electronic submissions. The rule which was proposed in September 2018 is expected to come into effect in 2020.
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December 30, 2019 Regulatory Affairs, Publishing & SubmissionsThe changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
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December 24, 2019 Medical Devices, Regulatory Affairs, Publishing & SubmissionsIn a recent notification, the South Korean national health authority - Ministry of Food and Drug Safety (MFDS) announced that the Agency no longer requires the submission of full summary technical documentation (STED) files for the registration of high-risk (class IV) medical devices.