Design Dossier Definition

A design dossier is a comprehensive document that provides assurance that a multisource (generic) product is clinically interchangeable with the innovator product, meeting the same standards as those applicable to the originator product. In other words, it demonstrates that the generic product satisfies the same requirements as the original product.

To achieve this, manufacturers of multisource products must submit a design dossier that includes detailed information about their product, such as its composition, manufacturing process, and testing results. This document serves as proof that the generic product has undergone rigorous testing and evaluation to ensure it meets the necessary standards for safety and efficacy.

The World Health Organization (WHO) plays a crucial role in the prequalification of products, including design dossiers. WHO's Prequalification Programme aims to ensure that quality-assured vaccines, medicines, and other health products are available globally. The programme provides technical assistance, training, and accreditation services to manufacturers, contract research organizations (CROs), and quality control laboratories (QCLs).

The design dossier is a critical component of the prequalification process, as it enables WHO to assess the product's conformity with international standards and regulations. The dossier includes various elements, such as:

1. Public Inspection Reports (WHOPIRs)

2. Post-prequalification Procedures & Fees

3. List of Prequalified Vector Control Products

4. About Vector Control Products Prequalification

5. Vaccines Eligible for WHO Prequalification

6. Support to Manufacturers, CROs, and QCLs

The design dossier is essential for ensuring the quality and safety of multisource products, ultimately benefiting public health by providing access to affordable and effective treatments.

By submitting a comprehensive design dossier, manufacturers can demonstrate their commitment to producing high-quality products that meet international standards. This, in turn, enhances consumer confidence and trust in the product. As the global healthcare landscape continues to evolve, the importance of design dossiers will only continue to grow, underscoring the need for rigorous testing and evaluation to ensure the safety and efficacy of multisource products.

Design dossier definition