All Pharmaceuticals articles

  • Over the counter decongestant medicines
    Industry news

    FDA committee finds OTC decongestants to be ‘ineffective’


    An FDA committee has reviewed phenylephrine − the active ingrediant in many over the counter decongestants − and agreed it is ineffective.

  • Supply-Chain-Medicines

    Navigating the
    pharmaceutical supply chain


    Matthew Scripps, Director, Supply Chain Planning, Mundipharma interviewed by Vickie Goff, TOPRA Editorial Board member

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    Regulatory considerations of a growing pharmaceutical company: a UK/US comparison of the generics industry


    Generics must demonstrate equivalence to the originator product to gain regulatory approval and market entry. There is a large market for generics that is predicted to continue to grow. The individual price of generics is lower than the originator, nevertheless manufacturers can avoid large development costs to bring generics to ...

  • Ozempic-Semaglutide
    Industry news

    Off-label prescription of diabetes drug causes shortage


    A spike in weight-related prescription of diabetes drug Ozempic has contributed to a national shortage, affecting those who need it.

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    Ensuring promotional
    materials’ compliance
    in the EU


    Directive 2001/83/EC is the EU legislation specifically covering promotional materials for the pharmaceutical industry – notably, Title VIII Advertising and Title VIIIa Information and Advertising. This is in addition to general consumer protection laws and unfair commercial practices regulations and directives. While Directives are legally binding and directly applicable to all companies. Some granularities can be introduced when it is transposed into national legislation by Member States (MS) individual legislatures.

  • Is consulting in regulatory affairs your next career path?

    Is consulting in regulatory affairs your next career path?


    Navigating the corporate ladder isn’t always clear cut. Along the way you may move in and out of the industry, stay in one position for too long, or even jump from specialist to director. Some ditch the politics all together and become their own boss. What is it like being a consultant, contingent worker, or contractor?

  • Environmental impact of pharmaceuticals and regulation in the EU

    Environmental impact of pharmaceuticals and regulation in the EU


    The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.

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    A View of…The Environmental Impact of Pharmaceuticals


    The body of research being published which is focused on the environmental impact of pharmaceuticals is increasing rapidly. It highlights a growing concern among the public for medicinal products accumulating in the natural world through a variety of originating sources.

  • paediatric

    A review of paediatric development challenges, FDA collaboration and future trends


    Susan McCune M.D. Susan McCune M.D., is a paediatrician and neonatologist, with 18 years’ academic clinical and research experience. This was followed by 18 years at the US FDA where, from 2017 to 2021, she was the director of the Office of Pediatric Therapeutics in the Office ...

  • brexit 2

    The impact of the Northern Ireland Protocol on human medicines


    Since the UK’s exit from the EU, the pharmaceutical industry has sought guidance on how this would impact the registration and supply of medicines, both in the UK and the EU. In addition, the publication of the Northern Ireland Protocol has added additional complexities, with a major impact on the ...

  • post brexit

    Pharmacovigilance regulations post-Brexit


    The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...

  • smol molecule

    Selection and justification of regulatory starting materials


    A regulatory starting material (RSM) is the registered point at which drug substance manufacturing under good manufacturing practice (GMP) begins. RSMs are defined, isolated materials that are required to meet the general principles outlined in ICH Q11. This article provides guidance for small molecules in selecting and justifying starting materials from a risk-based perspective.