Common technical document (CTD) is a harmonized format of documents that is recognized globally across the world for submission of application to country specific regulatory authorities for the registration of medicinal products. It organize the documents of pharmaceutical products including quality, safety, and efficacy data together into five different modules, that is known as “dossier”. CTD dossier format was developed by the International Council For Harmonization (ICH) for regulatory submissions, the main objective of CTD dossier is to simplify the submission process of documents across the various countries of the world, making the approval of medicine simple and fast.
What Is CTD & Why It Is Important?
CTD is a collection of data from different departments including quality, safety, and efficacy data arranging then simultaneously into five different modules to regulatory authority for the registration of products. The importance of CTD is discussed below:
- CTD dossier is recognized internationally, as It is important for simple and quick processing of submission to regulatory authorities in various countries.
- It helps in easy access of application more systematically.
- CTD enhances the application approval process of pharmaceutical products.
What Are The Modules of CTD?
CTD dossier compromises of five modules, each having specific information about pharmaceutical products as discussed below:
Module 1: Administrative Information
This module have administrative and regional information about pharmaceutical products. The content and data included in module 1 varies according to the country of product registration. Some of the important documents under module 1 includes:
- Cover letter
- Application form
- Product information leaflet (PIL)
- Summary of product characteristics (SMPC)
- Certificate of pharmaceutical products (CoPP)
- Good manufacturing practice (GMP)
- Manufacturing license
- Free sale certificate
- Artworks
Module 2: Summary of Module 3,4,and 5
This module consist of summary for module 3,4, and 5. It serve as the short and quick accessible data for the reviewer to understand the important points of dossier. Essential points covered in module 2 are as follows:
- Quality Overall Summary (QOS): This part involves a short information about quality data of product that is completely covered in module 3.
- Non clinical Overview Summary: Summary of non clinical information about the product is provided in this section of module 2 in the tabular form.
- Clinical Summary: This section contains clinical summary data of module 5.
Module 3: Quality
This module involves quality data of pharmaceutical products. It includes technical information about both drug substance and drug product. The data described under this module are as follows:
- Drug Substance: Active Pharmaceutical Ingredients (API)
General information including structure and nomenclature of drug substance
Manufacturer information along with the complete process of manufacturing of drug substance
Characteristization & impurities of API
Control of drug substance
Reference standard used
Container closure system for packing of API
Stability data (accelerated and long term) - Drug Product: Finished Pharmaceutical Products.
Description of finished product
Pharmaceutical development report
Manufacturer information along with the complete process of manufacturing of drug products
Control of excipients
Control of drug products
Reference standard used for finished product
Container closure system for packing of finished product
Stability data (accelerated and long term)
Module 4: Non-clinical Study Reports
This module involves compilation of non clinical data, demonstrating the safety of drug through animal and in vitro studies. This data includes:
- Pharmacological Data:
Primary and secondary pharmacological data. - Toxicology Data:
Single dose toxicity, reported dose toxicity, genotoxicity, and carcinogenicity. - Pharmacokinetic Data:
Absorption, distribution, metabolism, and excretion data.
Module 5: Clinical Study Reports
This module contains all the clinical information about human study. This module provides the data about safety and efficacy of drug for intended population.
- Clinical Study Reports:
Safety and pharmacokinetics information in healthy patients.
Optimization of dose on small population.
Efficacy and safety in large population. - Biostatistics:
Statistical analysis data. - Post Marketing Data:
Pharmacovigilance and risk management plan.
What Are The Advantages of CTD Dossier Format?
There are many positive sides of CTD dossier in pharmaceutical world. Some of the major advantages are as follows:
- Standardization: This helps in ensuring uniformity of product documents for global regulatory submissions.
- Competence: Simplify regulatory review and approval processes.
- Global Acceptance: This format of CTD is recognized internationally across the world.
How Medwisdom Lifescience Can Assist You With CTD Dossier?
Medwisdom Lifescience ensures preparation and compilation of CTD dossier for global markes, offering several benefits as mentioned below:
- Technical Documents Preparation: Complete module compilation from module 1 to module 5, including technical documents and providing other legal documents support inline with specific country regulatory guidelines.
- Regulatory Expertise: Ensuring regulatory compliance with global regulatory requirements.
- Overcoming Difficulties: We make the CTD dossier customizing according to client needs with respect to specific regulatory authority across the world.
- High Efficiency : Simplify the process with expertise that will save the time and making the project cost effective.
FAQs
Who Needs CTD Dossier Preparation Services?
Pharmaceutical, medical device, and biotechnology companies needs CTD dossier preparation services for the purpose of product registration in CTD acceptance country.
What Is The Timeline For Preparation of CTD Dossier?
The timeline exclusively depends on availability of technical documents from different departments of pharmaceutical industry, on an average it takes 5-6 days.
Is CTD Format For Product Registration Uses Globally?
Yes, CTD dossier is recognized and accepted by major countries and regions, but some modifications are required to make in (module 1) administrative information.
What Are The Documents Required For Preparation of CTD Dossier?
Most important documents required for CTD dossier preparation includes Drug Master File (DMF), Process Validation Report (PVR), Batch Protocol Report (BPR), Batch Manufacturing Report (BMR), Stability Data, Master Formula Record (MFR), Specifications for (Finished product and excipients).