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Regulatory Intelligence Newsletter
Stay current on country, regional and global regulatory changes with ICON’s monthly Regulatory Intelligence Newsletter.
MDR and IVDR: Where are your legacy products in the compliance process?
The European Parliament has voted to adopt a proposal by the European Commission to extend the MDR transition period.
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
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 It also summarizes the most salient recommendations for sponsors from the FDA’s Draft Guidance for Industry on Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.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and legal jurisdictions across countries for decentralised clinical trials, including a summary of the recent FDA draft guidance on the use of digital health technology.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.
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.
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.
Regulatory media articles
How will NICE fare in a post-Brexit world?
The impact of Brexit on the regulatory body, NICE, including NICE’s strong influence on the European market.
The significant role of a robust regulatory intelligence process in global safety submissions
Pharmacovigilance insights on the efforts towards the international standardisation of electronic transmission of drug safety information to achieve a unified objective of patient safety.
What clinical holds and pauses mean for COVID-19 countermeasure timelines
ICON’s Nuala Murphy and David Morse discuss trial pauses and clinical halts after three high-profile COVID-19 trials are temporarily halted as a result of potential safety issues.
What manufacturers can learn from medical device regulation (MDR) preparations?
ICON's Angela Brown considers what manufacturers can learn from medical device regulation (MDR) and the effect it will have on the in vitro diagnotic landscape (IVD).
Challenges associated with new EU MDR and IVDR
The key challenges associated with the new EU MDR and IVDR in this article in Med-Tech Innovation News.
The need for new business models under MDR/IVDR
A thought leadership article on the approaching deadline for the new medical devices regulation (MDR) & in vitro diagnostic device regulation (IVDR).
The impact of real world evidence on drug marketing approval and reimbursement
Increasing use of real world data and real world evidence for market regulatory decisions can lead to a more holistic understanding of safety and potency factors for healthcare practices.
Medical device classifications and applicable Food and Drug Administration regulations
Medical device manufacturers should understand how their product is viewed by regulatory bodies to proceed with the appropriate regulatory pathway to market.
MDR certification bottleneck
It is of paramount importance that companies with expiring certification begin the process to remain compliant under the new MDR. Read more about identified challenges and solutions.
Progressive IVDR rollout made official
As of 15 December 2021, the European Parliament and the European Council have adopted their proposal to make the suggested progressive IVDR rollout timeline official.
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.
Event report - DIA Europe 2021: Advancing health priorities
Shradha Galaya, Director of Global Safety Regulatory Reporting, reports on the highlights of her recent virtual attendance at DIA Europe 2021.
ISO 14155: Increased emphasis on clinical data continues to trend for medical device regulations
Over the past several years, regulations for the medical device industry have continued to evolve placing more emphasis on clinical data and patient safety.
New UKCA (UK Conformity Assessed) marking
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published new guidance on how it will regulate medical devices starting in January 2021.
Changes in clinical safety reporting to the FDA
FDA has upgrade the Investigational New Drug (IND) safety reporting from paper eCTD format to E2B format, improving potential safety signals in clinical studies.
The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
The shifting diagnostics regulatory landscape amid COVID-19
For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.
MDR/IVDR regulatory round-up
To ensure compliance under MDR and IVDR, manufacturers should act quickly to identify and secure a notified body (NB). Manufacturers should evaluate expertise and resources to determine which NBs are the best fit for their products
COVID-19 and respiratory devices: A dynamic market and evolving regulations
The respiratory devices market is witnessing enormous demands across the globe, resulting from the increased need for ventilators due to rising COVID-19 cases.