The International Pharmaceutical Excipients Council (IPEC) is working with other groups of experts across the stakeholder community to prevent questionable safety concerns raised in Europe about the use of titanium dioxide in foods from resulting in a ban on its use in formulating drug products.
Because of a link between food and pharmaceutical legislation in Europe, a January 2022 EU regulation removing titanium dioxide (TiO2) from the list of authorized food additives could result in it not being allowed in drugs, unless a second review by the European Medicines Agency – to be completed by April 2024 – provides sufficient justification for its continued use. Industry input to the updated EMA review is due by November 2023.
The regulation calls on the pharmaceutical industry to accelerate R&D on alternatives and to replace TiO2 in both new and already authorized products, unless “objective, verifiable reasons” can be provided for the lack of feasibility of doing so.
In recognition of the urgency to get supporting data on the table and to head off concerns raised by advocacy groups in view of the EU ruling, IPEC is spearheading action to: ● strengthen the weight of scientific evidence on the safety of TiO2 in pharmaceuticals ● detail the technical challenges in finding suitable TiO2 replacements, and ● emphasize the impact that reformulation would have globally on industry, regulators, and ultimately patients.
At the 2023 IPEC Excipient World Conference held in Washington, DC in early May, leaders from the pharmaceutical industry and excipient suppliers convened for a panel discussion to raise awareness of the current situation and the collaborative efforts that are underway to provide the evidence needed to inform the EMA review.
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