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Regulatory
Rapporteur

Write to the Editor at publications@topra.org

April 2024 | Vol. 21 | No.4

EDITORIAL

Improving outcomes with data

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, philosophically, without data we do not exist. Quality, safety and efficacy are the fundamental pillars of our profession.

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By James McCormick

FOCUS

Data quality, governance and sharing to enable insights and decision-making

Digitisation and innovation have transformed the ways in which clinical trials are conducted. This evolution requires industry to monitor and adapt its data management and governance practices in order to keep pace. This article discusses the digital developments in clinical trials and the opportunities for industry to enhance efficiency, accuracy and cost-effectiveness when developing drugs.

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By Fiona Maini, Taliesin Prole and Vada Perkins

FOCUS

Revolutionising drug development: unveiling the synergy of AI’s regulatory harmony in shaping the future of biopharmaceutical progress

The application of artificial intelligence (AI) in the biopharmaceutical field is continually expanding and reshaping the landscape. This article discusses the role of AI in supporting the development of innovative therapies and life-changing medications, from accelerating the drug discovery process to enhancing patient safety.

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By Baily Thomas, Madison Burns, Danielle Helton Corwin andEddie Reilly

FOCUS

Device submissions for combination products: a data-driven perspective

As innovation drives the development of combination products, a data-driven approach is indispensable for sponsors navigating the device aspects of the combination product regulatory submission process. This article discusses the challenges and opportunities of adopting a data-driven approach to device submissions.

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By Ola Oyinloye

FOCUS

Navigating the future of medicinal product data exchange: understanding XEVMPD and its crucial role in regulatory compliance

The EMA will transition from the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to the International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards to better standardise the exchange of medicinal product information. This article discusses the current XEVMPD and the future transition to IDMP standards.

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By Ratnam Tammineedi, Navaneetha G, Prabu Selvaraj, Anil Kumar M, Anamika Goel, Manju Joon, Kirti Yadav, Jacci Squire, Vivek Tomar andAllison Gillespie

STANDALONE

Choosing the right registration pathway for the China drug master file: an essential analysis of the options

This is the second article in a six-part series that focuses on the regulations in China’s drug market. This article provides a detailed discussion of China’s drug master file registration pathways, with specific focus on the pathway options for active pharmaceutical ingredients, excipients and packaging material products.

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By April Wang

STANDALONE

Managing risks: successful clinical development in asthma

The spectrum of causes and presentations of asthma, from population to responses to treatment, can make it challenging to trial and develop new treatments. This article identifies some of the key risks involved when conducting asthma trials and aims to improve awareness and assist with clinical development of medicines for use in asthma.

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By Peter Kiely, Anthony Bohnert, Simona Stankeviciute, Cecil Nick, Sinan Sarac andIulia Biro