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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.

Using data from externally controlled trials in rare disease clinical development

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 It also summarizes the most salient recommendations for sponsors from the FDA’s Draft Guidance for Industry on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.

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EMA guideline

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.

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 Navigating the regulatory labyrinth of technology in decentralised clinical trials

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and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.

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Navigating orphan drug development from early phase to marketing authorisation

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. 

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Procedural and regulatory know-how for China biotechs in the EU

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. 

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Global agency meetings

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.

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European Union Clinical Trial Regulation

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.

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Transfer of marketing authorisation

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.

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Keeping the end in mind: key considerations for creating plain language summaries

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.

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Requirements & strategy considerations within clinical trial transparency

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.

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Current overview of data sharing within clinical trial transparency

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.

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The RACE for Children Act

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.

Explore more updates on the RACE for Children Act
The evolution of the Pharmacovigilance System Master File

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.

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Spotlight on regulatory reforms in China

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.

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Early engagement and regulatory considerations for biotech

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.

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Seeking parallel consultation from regulators and HTAs in Europe

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.

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The key to success under MDR and IVDR

Early planning: The key to success under MDR and IVDR

The European Union’s new Medical Device Regulation (MDR) came into effect on 26 May, 2021, and In Vitro Diagnostic Device Regulation (IVDR) will come into effect one year later. These new directives will bring:

  • Elevated clinical requirements
  • Re-classified and up-classified devices
  • A changing role of notified bodies, leading to bottlenecks and delayed timelines.
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Regulatory Intelligence newsletter

Regulatory Intelligence newsletter

Stay current on country, regional and global regulatory changes with ICON’s monthly 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. 

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