Registration Dossier- A Comprehensive Guide
This article contains the comprehensive information about the Registration Dossier for different countries.
Registration Dossier- A Comprehensive Guide
What is mean by Dossier in Pharmaceutical Industry ?
A Dossier /Registration dossier in the pharmaceutical industry is a comprehensive document that contains all the necessary information about a drug product or medicinal substance.
The dossier is submitted by the pharmaceutical company to regulatory agencies to obtain approval for marketing the drug product or substance.
The registration dossier typically contains detailed information about the quality, safety, and efficacy of the drug product or substance. This information includes the results of preclinical and clinical studies, manufacturing and quality control data, information about the formulation and composition of the drug product, and details about its proposed use and dosage regimen.
The format and content of a registration dossier can vary depending on the country or region in which it will be submitted. In the European Union, for example, the dossier is submitted in a format known as the Common Technical Document (CTD) and in Asian countries format known as Asian Common Technical Document (CTD).
Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs
What is mean by Common Technical Document (CTD) ?
CTD stands for Common Technical Document. It is a standard format for the preparation of registration dossiers for medicinal products that is recognized by regulatory authorities in many countries.
The CTD provides a common structure and format for organizing and presenting information about a medicinal product or substance, including data from preclinical and clinical studies, information about manufacturing and quality control, and details about the proposed use and dosage regimen.
Authorities in United States, European Union (EU) and Japan ask for the Common Technical Document (CTD) format set out International Conference on Harmonization (ICH) which was agreed by the Regulatory Agencies of Europe, Japan and the US.
The Common Technical Document is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities.
Image I : CTD Triangle
What is mean by Asian Common Technical Document (ACTD) ?
This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will be submitted to ASEAN regulatory authorities for the registration of pharmaceuticals for human use.
This guideline describes a CTD format that will significantly reduce the time and resources needed to compile applications for registration and in the future, will ease the preparation of electronic documental submissions. Regulatory reviews and communication with the applicant will be facilitated by a standard document of common elements.
The ACTD generally consists of Parts I, Part II, Part III and Part IV
Image II : ACTD Triangle
