by In2Pharma | Jun 27, 2023 | News
Europe EMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact . Medicine shortages are a global health problem and are increasingly affecting European...
by In2Pharma | Apr 3, 2023 | News
Europe Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2022 inflation rate was 10.4%. The adjusted fees for all...
by In2Pharma | Jun 21, 2022 | News
Europe On 19 April, the “Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021” was published. This annual report of the GMP/GDP Inspectors Working Group (GMP/GDP IWG) gives a short but good overview of what was...
by In2Pharma | Sep 3, 2021 | News
Europe On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.The marketing status overview will provide to EMA and...
by In2Pharma | Sep 3, 2021 | News
Europe EMA published a guideline, effective from 1 January 2022, on quality documentation for medicinal products when used with a medical device (first version). The guideline describes the information that should be presented in the Quality part of a MA dossier for a...
