All Regulatory Rapporteur articles in July/August 2023
View all stories from this issue.
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PodcastsRegRapPod − July/August 2023
Vol.20 #7: In the July/August 2023 episode of RegRapPod, podcast host Alan Booth hears from Issue Editor Ash Ramzan about equal access to medicines.
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JournalEU versus Rest of the World regulatory frameworks and requirements for human tissue-based products
After participating in and/or hosting over 100 global competent authority inspections, the only true consistency is that no two inspections are the same. I see so many companies try to predict the inspectors approach, agenda…even the physical route they will take prior to the audit. Some upfront risk assessment and ...
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JournalA year of clinical trials under IVDR:
a sponsor’s perspectiveThe new EU in vitro diagnostic medical devices regulation (IVDR) extends to medical use of in vitro diagnostics (IVDs) in clinical trials, in addition to marketed IVDs. Although compliance to some aspects has been required since the Date of Application on 26 May 2022, there has been ...
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JournalRegulatory challenges and opportunities facing hearing aid manufacturers in Europe
In a world where many people are living longer but not all are living well and age-related hearing loss affects approximately 20% of the European population aged 65 or older – hearing aids address a medical need which for the most part remains unmet. With increasing evidence ...
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JournalAfrican Medicines Agency and a new African regulatory ecosystem
Regulatory Rapporteur July/August 2023 | Volume 20 | No.7 Introduction and background The African medicines regulatory landscape is evolving rapidly. The African Medicines Agency (AMA) is being established as a Specialised Agency of ...
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EditorialEqual access to medicines:
finding the balanceRegulatory Rapporteur July/August 2023 | Volume 20 | No.7 This edition of TOPRA’s Regulatory Rapporteur journal explores some of the challenges faced by regulatory professionals around the world; from the African regulatory ecosystems, to health technology assessment (HTA), and the ongoing ...
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JournalA critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2
GRAY, MSc − PART TWO OF A TWO-PART SERIES(See part 1 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory agencies such as EMA and FDA regard provision of SA as a ...
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JournalImpact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)
The EU Medical Device Regulation 2017/745 (EU MDR) and guidance on clinical evaluation (MEDDEV 2.7.1 Rev 4) have replaced the previous regulations governing the placing of medical devices on the European market. Concerning that these new requirements may be difficult to implement and pose an additional burden to Medical ...
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