WHO's New Draft Guideline on Submission of Quality Data for Generic Medicinal Products

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

At the beginning of March, the WHO published a draft document entitled "Guidelines on Submission of Documentation for a multisource (Generic) Finished Pharmaceutical Product: Quality Part". The document provides recommendations on the submission of quality information for APIs and finished medicinal products with regard to national authorisation procedures for generic medicinal products. The basis for this is the modular structure of the CTD according to ICH M4Q which has been completely taken over by the WHO guideline.

The scope of this guideline encompasses generic medicinal products containing APIs which have been previously approved through a finished product by a regulatory authority which is a member of the ICH or an ICH observer. The guideline doesn't apply to biological, biotechnological and herbal APIs.
 
There are several scenarios for generic medicinal products regarding diverse API manufacturers, medicinal product strengths, containers, dosage forms, etc, like for example:

• The medicinal product contains several APIs.
• The API comes from multiple manufacturers
• The medicinal product is manufactured with multiple strengths (e.g. 10, 50, 100 mg)
• The medicinal product is manufactured with multiple container closure systems (e.g. bottles and unit dose blisters)
• The medicinal product is available in different dosage forms (i.e. tablets and a parenteral product)
• The medicinal product is supplied with reconstitution diluents.

The guideline provides concrete recommendation on how to submit information within the CTD structure.

The document ends with an appendix about conducting and assessing comparative dissolution profiles.

The guideline can be commented until 25 April 2013.