What is the CTD (Common Technical Document) Dossier  

Since November 2016, with the entry of ANVISA as a regulatory member of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), Brazil has committed to implementing international reference guidelines. Among them, the ICH M4 Guidelines, which define the organization of the CTD (Common Technical Document) for the registration of human medicines. 

This format is already consolidated in international agencies such as EMA and FDA and will also become the standard in Brazil. However, its preparation requires experience and robust scientific knowledge, especially since it brings all the information about the medicine and is essential at the time of submission to the regulatory agency.  

Structure and Organization of the CTD Dossier 

The CTD dossier is divided into five modules, which encompass the different evaluation areas necessary for the registration process: 

• Module 1: Administrative and Specific Information of the Region 

This module contains essential administrative data for the registration request, such as petition forms, labels, and package inserts of the medicine. ANVISA defines the specific requirements for this module in Brazil. 

• Module 2: Common Technical Document Summaries 

This module presents a general summary of quality, non-clinical and clinical overviews, as well as tabulated and written summaries of non-clinical and clinical studies, providing an overview of the medicine and its trials. 

• Module 3: Quality (CMC – Chemistry, Manufacturing and Controls) 

Contains detailed information about the quality of the medicine, including data on the active pharmaceutical ingredient, the manufacturing processes, and quality control specifications. 

• Module 4: Non-Clinical Study Reports 

This module presents data on non-clinical studies, such as pharmacology, toxicology, and pharmacokinetics, which are essential for evaluating the safety of the medicine. 

• Module 5: Clinical Study Reports 

Module 5 covers clinical studies conducted in humans, focusing on the efficacy and safety of the medicine, with a detailed description of the clinical trials conducted at different stages of development. 

Each module serves to organize the technical information clearly and accessibly, facilitating regulatory analysis and expediting the approval process, making the CTD an essential tool for the success in the registration and post-registration of medicines. 

The Importance of Technical Expertise in Preparing the CTD  

Synvia stands out for its ability to prepare all modules of the CTD dossier, following the pre-established guidelines of ANVISA for this documentation format (Guideline No. 24/2019), in addition to using the ICH guidelines as a basis. 

The company has a highly qualified team composed of masters, doctors, and post-doctors specialized in scientific writing and regulatory document analysis. The approach is precise and detailed in evaluating data and structuring complex documents, ensuring total international regulatory compliance. 

Over 20 years of expertise in the pharmaceutical sector allows Synvia to perform a rigorous review of the scientific literature, facilitating the construction of the dossiers. With a deep understanding of regulatory requirements, the company ensures technical excellence, optimizing the submission process. 

This training is essential, for example, for the abbreviated pathway process, which will be addressed in the next topic, and is notable for accelerating the registration of medicines. 

Advantages of the Abbreviated Pathway in Medicine Registration 

The abbreviated pathway  is a regulatory process that allows for the acceleration of new drug approval based on consolidated scientific literature and CTD regulatory submission. In Brazil, RDC 753/2019 and RDC 948/2022 are the main regulations governing this process, allowing the use of data from consolidated scientific literature, such as scientific publications and data from previous studies, to demonstrate the safety, efficacy, and quality of medicines. 

here in the RDCs part, an external link to the ANVISA website about these RDCs can be inserted 

The abbreviated pathway is especially advantageous for medicines with a profile already well documented in terms of safety and efficacy, or that already have a consolidated use in other regions. 

Main advantages of the abbreviated pathway: 

• Faster registration with ANVISA. 

  
  

• Cost reduction for developers. 

  
  

• Utilization of existing data in scientific literature. 

  
  

• Quicker access for the population to new treatments. 

  
  

Synvia specializes in registering medicines through this pathway, offering an efficient solution for pharmaceutical companies and ensuring that the registration process is accelerated without compromising quality or regulatory compliance. 

Why Choose Synvia for Your CTD Dossier? 

Synvia is recognized for its integrated solutions that encompass all phases of the drug lifecycle, from initial development to registration and post-registration.   

With a track record backed by more than 20 years of experience, it delivers consistent results for the global pharmaceutical industry. It combines scientific quality with profound regulatory knowledge (ANVISA, EMA, and FDA) and state-of-the-art infrastructure, making the company a strategic partner to accelerate regulatory submissions without compromising compliance.  

Differentiators that prove expertise: 

• More than 1,600 clinical studies conducted. 

  
  

• Partnership with +200 global pharmaceutical industry sponsors. 

  
  

• Largest analytical park in Latin America. 

  
  

• Multidisciplinary team with masters, doctors, and post-doctors. 

  
  

• Experience in CTD and abbreviated pathway registration with ANVISA, EMA, and FDA. 

  
  

With agility and precision in the preparation of CTD dossiers, Synvia meets international regulatory standards, offering an efficient and safe solution to expedite the registration process and bring new medicines to market. 

Contact our medicine registration and CTD dossier preparation experts now: comercial.cro@synvia.com