All Journal articles – Page 11
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JournalChoosing the right registration pathway for the China drug master file: an essential analysis of options
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Abstract Building upon the foundational insights presented in the first article of our China series, this subsequent piece delves deeper into the intricacies of China’s drug master file (DMF) ...
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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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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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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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JournalCan the Japanese phase I study be waived?
New guidance: ‘Basic principles for conducting phase I studies in Japanese prior to initiating multi-regional clinical trials including Japan for drugs in which early clinical development is preceding outside Japan,’ issued in December 2023
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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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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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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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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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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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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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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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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 ...