On 5 August 2023, the European Commission requested the European Medicines Agency (EMA) to provide an updated analysis on the feasibility of replacing titanium dioxide in medicinal products. This request followed EMA’s interim conclusions from 8 September 2021.
The European Commission’s goal was to determine whether viable alternatives to titanium dioxide could be found without compromising medicine quality, safety, or efficacy — and, if feasible, to assess the potential impact on the availability of medicines.
Conclusions:
- No viable universal alternative: Investigations so far confirm EMA’s 2021 conclusion — it is not technically feasible to replace titanium dioxide in all medicines without affecting their quality, safety, or efficacy.
- Long transition required: Even in a hypothetical scenario where a suitable alternative is identified, EU regulatory experts estimate a transition period of more than 12 years would be necessary to phase out titanium dioxide in medicinal products.
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