All Journal articles – Page 6
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JournalNew data protection for maximum residue limits
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract Maximum residue limits (MRL) have been a requirement for all substances included in veterinary medicines intended for food-producing animals since the 1990s. The new Veterinary Medicines Regulation ([EU] 2019/6) ...
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JournalClinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...
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JournalNavigating the regulatory terrain down under: trends in Australia for 2024
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Introduction Australia is the most populous country in Oceania, and ranks 55th globally with its population around 26 million. It also ranks consistently high in other indicators that demonstrate the ...
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JournalThe rise of FemTech and why compliance is key to its success
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract This article explores the evolution of FemTech, which refers to products, services, medical devices, diagnostics and software that supports the health of women or people assumed as female at ...
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JournalChina drug master file: registration pathways and requirements
This is the first article in a six-part series that will focus on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements. ...
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JournalChemical characterisation: a critical first step for medical device development
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Introduction Chemical characterisation is an important tool to demonstrate biological safety of medical devices prototype before pre-clinical and clinical assessment. This article proposes a proactive approach to integrate chemical characterisation ...
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JournalEU MDR implementation – what is changing for the medical device industry?
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract This article focuses on the impact of the Medical Device Regulation (MDR) transition extension period and provides guidance for medical device manufacturers on the new Regulation (EU) 2023/607. ...
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JournalOverview of medical device regulations in Canada
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Despite being a relatively small jurisdiction, Canada’s Medical Device Directorate (MDD) plays a dynamic role in shaping global regulations and taking a leadership role in regulatory harmonisation and convergence. ...
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JournalAI meets medtech:
big opportunities
require a
measured approachRegulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Artificial intelligence (AI) and machine learning (ML)-enabled digital health technologies have great potential to improve patient care, strengthen diagnostic capabilities and enhance treatment options. Governments and healthcare professionals understand ...
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JournalNavigating early drug development investment: a detailed guide to due diligence
Funding is undoubtedly one of the major challenges small and medium-sized companies face when developing a new therapy from the bench to the clinic and eventually to the market. Suitable partnerships and potential mergers and acquisitions are key drivers to take a drug development programme to the ...
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JournalCell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...
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JournalThe changing face of oncology development – is cancer still ‘different’? A US perspective
Oncology development has traditionally been thought of as ‘different’; that the rules that applied to other therapy areas were not necessarily applicable to the development of treatments for cancer patients, who until relatively recently, had exceedingly limited treatment options. Dose finding was based on the paradigm adopted for cytotoxics and ...
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JournalArtificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
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JournalInnovating and harmonising access and requirements amid the global regulatory challenges of biologics
This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be ...
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JournalMD3: Navigating the regulatory maze: challenges of medical device software
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Dr. Célia Cruz, Chief Regulatory Affairs Officer, Complear Health, Portugal. Speakers and panelists: Mariana Madureira, Senior Officer at Health Products Directorate, Infarmed, Portugal. Abtin Rad, ...
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JournalMD2/IVD2:
Medical technologies −
a catalyst for
regulatory innovationsRegulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader Alwin van den Broek, Medical Devices Professional, the Netherlands. Maaike Labots, Manager Medical Writing, Avania Clinical, the Netherlands. Speakers and panelists Maryam Atakhorrami, Global ...
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JournalHM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Bjørg Hunter, Director, Regulatory Affairs Digital Health & IVD, Novo Nordisk, Denmark. Speakers: James Bertram, Director, Office of Combination Products, U.S. Food and ...