Europe, Australia, and US Enter Regulatory Information Agreement
The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers.
The European Directorate for Quality of Medicines & HealthCare (EDQM) has established bilateral confidentiality agreements with the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA), respectively, to share non-public information regarding inspections of active pharmaceutical ingredients (API) and excipients manufacturers. These agreements will facilitate the participation of the three organizations in a pilot project involving European regulators, the FDA, and TGA aimed at rationalizing international good manufacturing practices (GMP) inspections.
The scope of the agreements includes exchange of information relating to active pharmaceutical ingredients and excipients used in the manufacture of medicinal products. The arrangement will not affect the authority of any agency to carry out its regulatory responsibilities, and each agency will have the right to decline to provide confidential information.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
