Pharmacy Daily | EU guidelines adopted

THE Therapeutic Goods Administration (TGA) has published a list of European Union/International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines adopted and effective as of 01 June. Medicine registration and update requirements are synchronous with both the EU and ICH guidelines. Situations where the TGA has not adopted overseas regulators’ guidelines include matters around development and manufacture as well as Product Information data, especially for vaccines. Others relate to Environmental Risk Assessment, clinical evaluation of vaccines, guidelines around choice of names for human medicines and certain conditions related to injectable medicines. For a full updated list of those international guidelines adopted and not adopted in Australia, CLICK HERE. MEANWHILE the TGA has also released the recently spent or repealed instruments list of instruments repealed by the Health (Spent and Redundant Instruments) Repeal Regulation 2014; for more, CLICK HERE.

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