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18. 8. 2022

Legal basis for chemical generics with biological reference medicinal product

CMDh recently discussed the applicable legal basis for generic products containing a synthetically manufactured active substance referring to a biotechnological or biological product.
5. 6. 2022

Digital application dataset integration (DADI)
launch in October 2022

DADI is a Network project led by EMA which will support both centrally authorised product applications and nationally authorised product applications.
27. 4. 2022

The replacement of the TiO2 (E171) excipient

Titanium dioxide is a frequently used excipient used as a pigment or protective coating in oral solid or semi-solid dosage forms. However, in 2021 EFSA published its opinion on the safety of TiO2 that currently available evidence along with all uncertainties.
4. 4. 2022

Food effect on bioequivalence

The bioequivalence of the medicinal product was proven only under fed conditions and NOT for fasting conditions. The legal basis of Article 10(3) has been applied for the dossier submission. SPC changes considering the difference in bioavailability were proposed as a risk minimization measure.
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