medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The European Commission (EC) has established a portfolio of the ten most promising treatments for COVID-19. A group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as the most promising for the…
This post will be updated on an ad hoc basis. Report from the CMDh meeting held on 12-13 October 2021 Some items of note in this report include the following: CMDh Best Practice Guide on Multilingual Packaging The CMDh has…
In September 2021, the European Medicines Agency (EMA) provided final feedback was provided to the European Commission (EC) on its request to evaluate the impact of the removal of titanium dioxide from the list of authorised food additives in medicinal…
The EU Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation. This is part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector and the latest step towards an…
The EU Digital Application Dataset Integration (DADI) project on web-based regulatory application forms is currently in progress. This project should have a wide ranging and positive impact on industry stakeholders and regulatory agencies in the EU. At its core appears…
The European Commission is conducting a targeted stakeholder consultation on the amendments to Commission Implementing Regulation (EU) 520/2012 on pharmacovigilance activities. About Commission Implementing Regulations A Commission Implementing Regulation is a legally binding act of the European Union. It is…
The Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council has been published. About commission Implementing…
The Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council has been published. About commission Implementing…
The European Commission (EC) has launched an online stakeholder consultation on the definition of nanomaterial. This consultation follows a review of its Recommendation 2011/696/EU on the definition of nanomaterial. The online targeted stakeholder consultation is to update, test and verify the preliminary…
The European Medicines Agency (EMA) is consulting the public on draft common EU standards for electronic Product Information (ePI). You can read more about ePI here. About the draft common standard for ePI The draft EU common standard for ePI…