The Novartis Anonymized Redacted Dossiers (NARD) is a publicly accessible website for Novartis to share dossiers submitted to Health Authorities for product approval in an anonymized/redacted format. As clinical trial transparency continues to grow globally, this central location to share anonymized/redacted dossiers allows Novartis to continue our commitment to data transparency.
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The following Health Authorities: Health Canada, European Medicines Agency (EMA) and Swissmedic require that clinical data, contained in dossiers, be made public. Learn more about these Health Authorities below by clicking on Learn More.
Health Canada makes anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes following the completion of Health Canada's regulatory review process.
The European Medicines Agency (EMA) website contains clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure and have been assessed by the Committee for Human Medicinal Products (CHMP).
Swissmedic is the national authorization and supervisory authority for drugs and medical products ensuring high quality, safe and effective medical products available in Switzerland.
Novartis' mission is to discover new ways to improve and extend people's lives. Using science-based innovation, Novartis delivers better outcomes for patients and addresses the evolving healthcare needs of society.
For over 20 years, Novartis has supported data transparency and was one of the first to commit to publishing trial results of innovative medicines within one year of study completion, regardless of outcome. As time has passed, we only continue to strengthen our commitment to data transparency.
For a drug to be approved each company must follow the ICH guidance regarding the assembly of all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.
Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease.