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On 26 July 2021, EMA has launched the IRIS platform, a secure online platform to report marketing status changes and withdrawn product notifications of centrally authorised medicinal products (CAPs) to EMA.The marketing status overview will provide to EMA and...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...
by In2Pharma | Jun 11, 2021 | News
Europe Regulation (EU) 2017/745 on medical devices is applicable in the European Union as of 26 May 2021. The Medical Device Regulation (MDR), was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and...
by In2Pharma | May 6, 2021 | News
Europe An important piece of the new Pharmaceutical Strategy adopted in November 2020 by the von der Leyen Commission is represented by the structured dialogue with the actors of the pharmaceuticals manufacturing chain in order to better identify causes and drivers of...
by In2Pharma | May 6, 2021 | News
Europe In a final assessment report, the EMA has published important information for marketing authorisation holders of angiotensin II receptor antagonists (sartans) regarding nitrosamine contamination limits and deadlines for risk mitigation measures. On 2 April...
