All Drug development articles
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Industry newsFAST-EU pilot delivers first results: 70-Day approval timelines prove feasible ahead of Biotech Act
The first results from the (Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial applications, ...
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JournalThe drug development lifecycle: Regulatory milestones and pathways for early-career professionals
Aimed at aspiring or newly appointed regulatory professionals, this article outlines key stages of the drug development lifecycle and highlights the critical role regulators play throughout the process.
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Industry newsFDA and EMA publish guiding principles of good AI practice in drug development
This industry news updates shares the ten principles of best practice for AI.
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ContentsRegulatory Rapporteur November 2025 – Contents
The November issue of Regulatory Rapporteur reports on sessions from the TOPRA Symposium 2025.
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JournalICH Q1 guideline revisions to promote innovation and enable global patient access to high-quality medicines
This article looks at the new ICH Q1 stability guidance and its various approaches to help promote innovation.
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JournalMaximising regulatory success through early EMA engagement in drug development
This article explores the importance of early regulatory engagement with the EMA and some tools, guidance and procedures on offer.
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EditorialFrom trials to approval: Regulatory strategies in early drug development
This issue focuses on the acceleration of early drug development, the opportunities and challenges that this brings and strategic guidance for regulatory professionals.
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ContentsRegulatory Rapporteur October 2025 – Contents
The October issue of Regulatory Rapporteur focuses on early drug development.
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JournalTarget product profile and product profile characteristics for labelling during drug development
This article analyses the role of the TPP and PPC in labelling development and uses case studies as examples.
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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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JournalInclusion of older people in drug development and clinical trials: Part 1
As the global population ages, older people will increasingly become the main users of medication. Much work has already been done by regulatory authorities to review legislation, leading to the 2013 publication of the EMA’s Geriatric Medicines Strategy. It reported, however, that many clinical trials still did not include a representative number of older people – aged 65 and over – despite the drugs in development were most likely to be used by this cohort. This two-article series will analyse if the publication of ICH E7 Q&A influenced the number of older people included in clinical trials. Furthermore, a qualitative questionnaire assessed the extent to which clinical trials are designed to adequately represent older people. In part one, I will focus on the legislative framework governing drug development for older patients, and the sub-classifications of age groups.
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JournalOn the path to adoption of decentralised clinical trials
Decentralised clinical trials (DCTs) offer great potential to improve the clinical trial paradigm, bringing more diversity and less burden to the participants we serve. COVID-19 has driven DCTs, offering greater flexibility to clinical trial patients. More needs to be done to make DCTs a standard option.
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Meeting ReportMD5: Innovation in Drug-Device Combinations
The session was opened by Bjorg Hunter posing a question about how innovative companies can manage often complex and different global regulations when they are developing connected, environmentally friendly products for the benefit of the patients…