Pharmaceuticals – Page 6
-
-
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, ...
-
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
-
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 ...
-
-
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 ...
-
-
Industry newsViolin resin works as cleaning agent for ‘superbugs’
A form of resin taken from a Norway spruce has been found to also function as an effective disinfectant against drug-resistant bacteria.
-
CommentaryCell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
Cell and gene therapy rare disease drug development in the US – general principles, challenges and a landscape of mutual regulatory concession
-
PodcastsRegRapPod − February 2024
Vol.21 #2: In February 2024’s RegRapPod, host Alan Booth talks to Issue Editors Dejan Brkic and Esteban Herrero-Martinez about medtech.
-
Industry newsNHS Pharmacy First offers an alternative to GPs in England
Pharmacists in England can now provide treatment for seven common health conditions without patients first consulting a doctor.
-
CommentaryDeveloping a digital people strategy to harness the power of generative AI
Artificial intelligence is a science and applied technology that involves deductive processing and machine learning subsequently performing human-like tasks
-
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. ...
-
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 ...
-
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. ...
-
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 ...
-
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. ...
-
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 ...
-
PodcastsRegRapPod − In Conversation with TOPRA’s RegOps SPIN
BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN
-
Industry newsScientists hail gram-negative-bacteria killing antibiotic
A novel class of antibiotic has been discovered that is effective against the extensive drug-resistant, gram-negative bacteria, Crab.