Overview:
In November 2016, Anvisa was accepted as a regulatory member of ICH and committed to implement the ICH M4 Guides, which define the organization of the Common Technical Document (CTD) for registration of medicines for human use in Brazil. The guides published by Anvisa provide the format and structure that companies may follow for the preparation and submission of dossiers submitted to the Agency.
Introduction:
The CTD is an essential document in the assessment of the medicine by regulatory bodies. It contains all the information necessary for the analysis of the quality, safety and efficacy of the medicine, including pre-clinical, clinical and pharmaceutical data. The standardization of the CTD format facilitates the review of regulatory dossiers by assessors, allowing for a faster and more efficient assessment of medicines.
The CTD provides a coherent and structured framework for the presentation of information, which facilitates the understanding and interpretation of data by assessors. This is especially important considering the increasing number of medicines that are submitted for regulatory assessment in Brazil. With the CTD, it is possible to organize the information concisely, making it easier to identify the main points of the medicine.
CTD Guide consists of five files:
- Module 1: Administrative Information and Package Leaflet and Labeling Information
- Module 2: Summaries of Common Technical Documents
- Module 3:Quality
- Module 4: Non-Clinical study reports
- Module 5: Clinical Study Reports
Registration Applications, Post-Registration
- Applications for registration, post-registration and linked additions should be filed in CTD format.
- The format/structure of organization of the dossier for registration and post-registration of medicinal products by dividing it into 5 modules.
Objective of the CTD Guide
- Reduce the time and resources needed to compile the information required.
- Facilitating the preparation of electronic petitions.
- Facilitate the assessment by ANVISA and communication with the applicant by a standard document of common elements.
Brochure : GRP Brazil Services
GRP Brazil Office provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical, medical device, and life-consumers companies worldwide to register them product with ANVISA the local Health Authority (HA).
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.