Important Aspects to consider if you use Titanium Dioxide in your Drug Products

What should you do, if you are an applicant of a new MAA or if you have products on the market which contain titanium dioxide? 

There is currently much discussion about the use of titanium dioxide due to the concern of genotoxicity. As food-additive it was banned, however the situation is different for pharmaceuticals, as this additive is widely used as colourant. It may therefore still be used to avoid stock-outs of many pharmaceutical products. But the Commission will re-evaluate the situation in April 2024 based on the updated EMA-assessment.

Therefore, you should start the thinking process now and make all possible efforts to replace titanium dioxide in the long-term run. This requires new development for the use of alternatives and the submission of variations once the composition is changed. 

You can find a recently published Q&A Document from EMA regarding the replacement/removal of titanium dioxide (TiO2) in medicines.

Please feel free to contact us at, if you like to know more. Many CMC-aspects need to be considered. We know the details and smoothly guide you through the process. Think about the future of your drug products now.

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