A Guide to CTD and DMF Files for Pharma Importers
These are the two documents that are important to import a pharmaceutical product into the destination country.
It ensures that the product to be imported is safe and efficient to be sold in the desired market.
It gives marketing access to the importers for the product.
The two files contain standard steps to harmonize the quality and safety of the products, opening gateways to countries worldwide.
What is CTD (Common Technical Document)?
It is a set of documents that is submitted to the regulatory authorities.
It consists of applications for the authorization to market the pharmaceutical product.
It is developed by the International Council of Harmonization that a single dossier shall be submitted to different regulatory bodies.
It consists of 5 modules.
Module 1 is specific to the country.
The other module remains the same for all the regions.
- Module 1 – It specifies the local labeling or the prescribing content as per the country.
- Module 2 – It summarizes the quality of the finished product.
- Module 3- It consists of the complete details of chemicals used, quality controls, and manufacturing processes.
- Module 4 – It contains all the non- clinical study reports.
- Module 5 – It includes the clinical study reports.
What is DMF (Drug Master File)?
It is a confidential document.
It is submitted by the manufacturer.
It consists of the manufacturing details of the API, intermediates, and the packaging material.
It consists of –
- Details about the API, its synthesis, and processes.
- Manufacturing facility layout, manufacturing processes used.
- Quality protocols, stability, shelf life, etc.
Why is it required for importers?
Importers need these 2 documents to ensure legal compliance-
- It is required to approve a new product in the market.
- It is proof of quality.
- It ensures the ingredients used are pure, safe, and stable.
- It protects intellectual property rights.
- It streamlines the global entry.
- Verify batch consistency and purity.
- build trust based on assured quality
Aprazer Healthcare Steadfast Import Approvals
Aprazer Healthcare navigates the regulatory processes without undue delays.
- Submitting dossiers
- Obtaining authorizations.
We maintain stringent quality parameters and standardized manufacturing processes.
By submitting true and unbiased information, we work in the interests of the stakeholders.
Our foundation, built on consistency and reliability, makes us the leading healthcare partners.
We are a leading pharmaceutical exporter to Asia, Africa, and South America.
