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Ukrainian pharmaceuticalcompanies are struggling to perform their duties in pharmacovigilance as Russia launched a wide-scale war in Ukraine. Russia’s full-scale invasion of Ukraine has already affected the global pharmaceutical industry a lot. This platform made work easier for many pharmaceuticalcompanies.
This article appears in our digital magazine, Deep Dive: Market Access 2021. Practically though, there are risks of additional processes and requirements (and expense) for pharmaceuticalcompanies. NICE has a global reputation as a pioneering HTA – but is that influence at risk now that the UK has left the EU?
In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceuticalcompanies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.
This allows pharmaceuticalcompanies to maintain their brand voice and facilitates information sharing. Many aspiring medical writers falsely believe they should market their services only to pharmaceutical and medical device companies. As most documents come in a PDF format, Adobe Acrobat is helpful for this task.
A collaborative mindset must prevail between pharmaceuticalcompanies, suppliers, and regulators and include strategic partnerships that go beyond the pharmaceutical sector so we can move together to a more sustainable future. The risks are equally applicable to both privately owned and publicly traded companies.
In the dynamic global environment, the approval times for postapproval changes can be expected to change over time and may well differ between pharmaceuticalcompanies based on different practices and approaches. The proposals are consistent with WHO GRP. Published March 2020. www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management_en.pdf
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