How to write a very good pharmaceutical dossier

Hello, can anyone share a sample dossier for application of sodium chloride 0.9% infusion registration

1 Like

Writing a comprehensive pharmaceutical dossier requires attention to detail and adherence to regulatory standards. Start by organizing the dossier into sections like administrative information, quality data, nonclinical and clinical data, and regulatory information. Include detailed information on the drug’s formulation, manufacturing process, stability data, and quality control measures. Present nonclinical data such as pharmacology and toxicology studies, followed by clinical trial data including efficacy and safety results. Ensure all data is accurate, transparent, and supports the drug’s efficacy, safety, and quality. Collaboration with regulatory experts and adherence to regulatory guidelines is crucial throughout the dossier writing process.

Please refer to ICH M7 Guidelines on “Common Technical Document”.
ORGANISATION OF THE COMMON TECHNICAL DOCUMENT FOR THE
REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE -M4
Current Step 4 version dated June 15, 2016

The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionized the regulatory review processes, led to harmonized electronic submission that, in turn, enabled the implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.

The CTD is organized into five modules. Module 1 is region specific and Modules 2, 3, 4, and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to the USFDA, United States.

Thank you

You are always welcome.

This topic was automatically closed 10 days after the last reply. New replies are no longer allowed.