All Editorial articles
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EditorialAdvanced therapies: A maturing regulatory framework
This issue looks at CMC requirements, recent therapeutic innovations in the oncology field, and the complex interconnection between ATMPs and in vitro diagnostic medical devices.
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EditorialSustainable pharmaceuticals
Regulatory Rapporteur July/August 2024 | Volume 21 | No.7 In this bumper July/August edition of Regulatory Rapporteur, we focus on sustainability and, in many aspects, we build upon our June theme of access to medicines. Sustainability in pharmaceuticals encompasses ...
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EditorialThe global access battle for healthcare equity
Regulatory Rapporteur June 2024 | Volume 21 | No.6 The World Health Organization (WHO) has estimated that one-third of the global population lacks regular access to essential medicines. The concept of access to medicines will likely resonate differently within ...
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EditorialUnlocking a new paradigm of healthcare through advanced therapies
Regulatory Rapporteur May 2024 | Volume 21 | No.5 It seems like a recurring theme to start our advanced therapy medicinal products (ATMPs) issue with a familiar message: we are undoubtedly entering a new paradigm of ...
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EditorialImproving outcomes with data
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Data, the focus topic for this month’s journal, brings together a range of articles which are underpinned by one uniting factor: our absolute dependence on it. Perhaps, ...
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EditorialDiverse and dynamic regulation in the Asia Pacific region
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Our first regionally focused issue for 2024 metaphorically travels to the Asia-Pacific (APAC) region. Asia makes up 60% of the global population and there are a large number of regulatory ...
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EditorialThe increasing complexity of biological medicinal products
Regulatory Rapporteur January 2024 | Volume 21 | No.1 The world of biologics is shifting rapidly. In the more than 40 years since the introduction of the first biosynthetic human insulin in 1982, advances in scientific understanding and biotechnology ...
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EditorialAdvancing global
healthcare togetherAn annual fixture since 2004, TOPRA’s Symposium is Europe’s premier conference for regulatory affairs professionals with dedicated programme streams for human and veterinary medicines, medical devices and IVDs. This year the Symposium was in Lisbon, in partnership with Infarmed, Portugal’s national authority of medicines and health products.
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EditorialVeterinary medicines: the challenges of new regulation
Regulatory Rapporteur October 2023 | Volume 20 | No.9 The October 2023 edition of TOPRA’s journal – Regulatory Rapporteur – focuses on topics and developments specific for veterinary medicines: From the challenging aspects arising ...
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EditorialThe worldwide web of regulation
In this issue, we focus on the pharmaceutical supply chain and the interaction of this function with regulatory. The supply chain team are the link between the manufacturer and the customer, and they are impacted by the complexity of regulations across different global markets and work with regulatory colleagues to ...