Annual report highlights progress in science, medicines and health in 2023

30 May 2024 - EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the ...

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Advancing regulatory science in the EU – mid-point report published

22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...

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Independent review of paracetamol overdose

14 September 2022 - The TGA has published an independent expert report examining the incidence of serious injury and death ...

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COVID-19 vaccine weekly safety report (17 March 2022)

17 March 2022 - To 13 March 2022, the TGA has received 457 reports which have been assessed as likely to ...

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Office of Generic Drugs 2021 Annual Report

14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...

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Advancing health through innovation: new drug therapy approvals 2021

13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...

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TGA reduces timeframe for publishing adverse event reports

19 August 2021 - With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our ...

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COVID-19 vaccine weekly safety report (8 July 2021)

8 July 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

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COVID-19 vaccine weekly safety report (27 May 2021)

27 May 2021 - Nine additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

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COVID-19 vaccine weekly safety report

20 May 2021 - Six additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

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TGA publishes AusPAR for Zolgensma

22 April 2021 - Rapid publication following approval. ...

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FDA updates list of off-patent, off-exclusivity drugs without an approved generic

17 December 2020 - Today, the U.S. FDA published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved ...

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TGA publishes AusPAR for Vemlidy

21 July 2020 - AusPAR published within days of its provisional registration; why do other take years? ...

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Half yearly performance snapshot: July to December 2019

6 May 2020 - The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the ...

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EMA publishes minutes of joint meeting with EUnetHTA - November 2019

5 May 2020 - This was the 18th meeting between the EMA and representatives from the EUnetHTA and attended by the ...

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