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Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks the flexibility, analytical power and efficiency to address today’s development demands. It is essential to develop a regulatory strategy plan early in drug development to identify key challenges that may arise, and interact collaboratively with regulatory authorities. This will also enable you to ensure that plan aligns with the profile and commercialisation for drug development.
Clinical strategies to optimise software as a medical device (SaMD) for treating mental health
Mental health disorders affect millions, and with increasing diagnoses, the demand for new, accessible treatments is growing. In this whitepaper, we examine how SaMD, particularly through digital therapeutics, is providing new solutions for mental health management.
Demystifying EU CTR, MDR and IVDR
Download now and demystify the EU regulation process for medical devices, in vitro diagnostic devices and combined studies.
Navigating FDA Medical Device Regulations
Episode 1: Warning letters and recalls
Hear our Medical Device experts explore FDA warning letters, recalls and the benefits of early clinical and regulatory engagement in this informative podcast. Tune in for practical information to avoid compliance pitfalls and stay ahead of the regulatory curve.
Using innovative tools and lean writing processes to accelerate regulatory document writing
In this whitepaper, we explore how these valuable tools, including software, templates and collaborative work processes, can provide practical solutions to common challenges medical writers face.
Using data from externally controlled trials in rare disease clinical development
This briefing document describes external control arms and provides concise information on the FDA’s regulatory precedent regarding their acceptable use. It also summarizes the most salient recommendations for sponsors from the FDA’s Draft Guidance for Industry on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.
EMA guideline on computerised systems and electronic data in clinical trials
This whitepaper provides an overview of the evolution of the new EMA guideline on computerised systems and electronic data, its scope, and its impact.
Navigating the regulatory labyrinth of technology in decentralised clinical trials
This whitepaper discusses the varying regulatory and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.
Navigating orphan drug development from early phase to marketing authorisation
In this white paper, ICON’s experts discuss the intricacies of orphan drug development and the challenges that both the US and EU experience, including the EU concept of significant benefit criterion.
Procedural and regulatory know-how for China biotechs in the EU
In this white paper, ICON’s experts outline potential regulatory strategies and interaction plans for sponsors in China as a guide for marketing authorisation applications in the centralised procedure to the EMA, which allows the marketing authorisation holder to market a drug product in all European Union (EU) Member States, in addition, specific countries in European Economic Area (EEA), with a potential patient pool of approximately 500 million people.
Global agency meetings: A collaborative approach to drug development
Read this briefing document to understand the specific consultation offerings, procedural steps, and timelines of regulatory agency meetings at various stages of drug development in the EU, US, Japan, China and Canada.
European Union Clinical Trial Regulation
The European Union Clinical Trial Regulation 536/2014 (EU CTR) introduces fundamental changes for interventional clinical trial submissions and approvals in all 30 countries of the European Union and the European Economic Area. The EU CTR has established a harmonised approach for clinical trial applications, assessment and reporting with consistent rules. Review our insights to understand the impact and strategic considerations for sponsors.
Transfer of marketing authorisation
A successful MAT application is a very complex and cross-functional activity, involving many steps that require insightful planning and execution. Good teamwork, planning, and communication between all stakeholders including any clinical research organisations (CRO) that work for the seller or buyer are critical success factors. Read the whitepaper for best practices and clear guidance on transferring medical products.
Keeping the end in mind: key considerations for creating plain language summaries
For sponsors preparing to meet short deadlines for PLS submission, this whitepaper outlines considerations such as creating compliant templates, endpoint consistency and inclusion, and health literacy.
Requirements & strategy considerations within clinical trial transparency
Read the whitepaper to learn about current clinical trial disclosure (CTD) requirements, future regulatory changes, and strategies for planning for disclosure.
Current overview of data sharing within clinical trial transparency
Sponsors preparing to share their clinical documents can incorporate best practices and implementation recommendations presented in this whitepaper, including considerations for planning and basic data anonymisation strategies for protecting patient privacy while balancing data utility.
The RACE for Children Act
Paediatric cancer is the leading cause of death by disease in the US. The intent of the RACE for Children Act is to get more paediatric oncology drugs in the pipeline.
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
Ensuring regulatory compliance with the PSMF
It is essential that those who hold Marketing Authorisations (MA) within the European Economic Area have an established Pharmacovigilance System Master File (PSMF), which should be ready at the time of submission of all new applications for MAs. This whitepaper assesses the effectiveness of a global PSMF and its benefits to study personnel.
Spotlight on regulatory reforms in China
China’s regulatory reforms have attracted many foreign companies to conduct clinical trials and register their medicinal products in China. However, the evolving regulatory environment and country-specific requirements present significant challenges.
Early engagement and regulatory considerations for biotech
What companies must consider when developing an asset and the importance of regulatory strategy
Gain insight into the common questions small and emerging biotech companies face, and the importance of early engagement and regulatory affairs when developing an asset and considering a drug development partner.
Seeking parallel consultation from regulators and HTAs in Europe
Understanding and meeting the evidence requirements of regulators and HTA bodies can be complex. Early engagement can help. Read the whitepaper for key factors to ensure that parallel consultation meetings are well prepared, productive and informative.
Global Regulatory Intelligence newsletter
Stay current on country, regional and global regulatory changes with ICON’s monthly Global Regulatory Intelligence Newsletter. It will keep you up to date with global regulatory changes that could impact your product.
Our experts review, interpret and summarise the latest regulatory developments so that you can spend more time taking your product to market.
Regulatory Intelligence media articles
Innovation and flexibility in long-term follow-up studies
Read insights from Harpreet Gill VP, Real World Solutions, on how sponsors can optimise their LTFU studies to be flexible and cost-effective, with strategic planning and innovation, overcoming challenges while capturing valuable data insights.
Cover Story - Regulatory CMC: Enhancing Biologics Development
Preventing delays and accelerating the progression of these critical therapies.
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The future of RWD and RWE in healthcare decision-making: Applications of novel real-world data collection methods for healthcare decision-making
Read insights from Jennifer Eriksson, Divisional Principal, on the use of real-world evidence and real-world data to inform healthcare decision-making and provide patients with rapid access to innovative healthcare technology.
EMA consolidates guidelines for computerised systems in clinical trials
To guide sponsors, investigators, CROs, and other parties in clinical research, the European Medicines Agency (EMA) has consolidated the contemporary requirements for using computerized systems and electronic data in clinical trials.
Implications of regulatory and FDA guidance on diversity, equity and inclusion on clinical research study sites
Missy Gottschlich, Director of Site Networks for Accellacare, provides key insights on how sites can implement regulatory guidelines on diversity, equity and inclusivity.
Confidently compliant? Considerations for industry players to meet the new EMA guideline
Vesta Marciulioniene, Director, Global Regulatory Clinical Services and Jo Hulbert, Executive Director, Global Regulatory Clinical Services provide an overview of the EMA’s new framework on computerised systems and electronic data in clinical trials in this article from XTalks Clinical Edge.
ICON interview: Insights on the new EMA guidelines for computerised systems and electronic data in clinical trials
Outsourcing Pharma spoke to Vesta Marciulioniene, director global regulatory clinical services at ICON Biotech, who shares her insights on the new EMA guideline for computerised systems and electronic data in clinical trials and what new expectations it sets for the clinical research industry.
Essential considerations for a successful submission under EU CTR
Introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions.
Regulatory Intelligence blogs
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Blog: Advanced therapies for rare disease - a regulatory roadmap
Navigating advanced therapy development for rare diseases is challenging from many perspectives and requires a customised development strategy.
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Blog: Progressive IVDR rollout made official
In the fall of 2020, the European Commission issued a proposal to modify the implementation timeline for the new In Vitro Diagnostic Medical Devices Regulation (IVDR). Now, as of 15 December 2021, the European Parliament and the European Council have adopted this proposal, making the suggested progressive IVDR rollout timeline official.
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Blog: EC proposes extended transition period for IVDR compliance
The European Commission has issued a proposal for a modified rollout of the new In Vitro Diagnostic Regulation (IVDR).
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Blog: Assessing the need for primary supporting clinical evidence or post-market clinical follow-up under MDR
Discover why identifying the study objective during the planning process for PMCF studies is a critical step in the transition to MDR.
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Blog: Legacy devices under MDR/IVDR: a path forward
Regulations from 2017 set stricter requirements on manufacturers product development, data reporting, and quality assurance in place.
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Blog: MDR & IVDR bottlenecks: Challenges persist despite deadlines
The new In Vitro Diagnostics Regulation (IVDR) and Medical Device Regulation (MDR) provide regulatory frameworks and conformity assessments that promote medical device safety and efficacy.
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Blog: Executing under pressure: Developing a strategy for high risk devices under IVDR
Manufacturers who have not begun preparations will need to adopt a strategy to address gaps in meeting the new regulation.
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Blog: Clinical Evidence under IVDR - how much is enough?
The new In Vitro Diagnostic Regulation (IVDR) aims to harmonise regulatory framework across the European Union (EU) to ensure the safety and performance of devices by placing greater responsibility on manufacturers to demonstrate that their products meet stringent requirements.
