The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS. Read more “EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter”
Category: Medicinal product
Highlights from the December CHMP meeting 2020
From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the December CHMP meeting 2020”
EMA publishes advice on Northern Ireland post-transition
The EMA have published a new question and answer guidance on the implementation of the Protocol on Ireland / Northern Ireland. Read more “EMA publishes advice on Northern Ireland post-transition”
WHO draft revised guidance on GMP for investigational products
The World Health Organisation (WHO) has released a draft working document to the industry for public consultation on good manufacturing practices (GMP) for investigational medicinal products (IMP). Read more “WHO draft revised guidance on GMP for investigational products”
The European Commission’s new pharmaceutical strategy
The European Commission (EC) has adopted its new pharmaceutical strategy for Europe, highlighting support for innovation, research and development. Read more “The European Commission’s new pharmaceutical strategy”
EMA publishes IRIS guide for parallel distributors
The EMA have published a guidance document for IRIS (Regulatory & Scientific Information Management platform) to help individuals to use the portal to submit a notification for parallel distribution. Read more “EMA publishes IRIS guide for parallel distributors”
Highlights from the November CHMP meeting 2020
From their meeting in November, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the November CHMP meeting 2020”
EMA encourages companies to submit type I variations for 2020 by end of November
The European Medicines Agency (EMA) has advised marketing authorisation holders (MAH) to submit type IA and type IAIN variations for 2020 no later than Monday 30 November 2020. Read more “EMA encourages companies to submit type I variations for 2020 by end of November”
Catch the latest updates to the MHRA transition period guidances
The Medicines and Healthcare products Regulatory Agency (MHRA) has published further guidance and updates in relation to supplying medicines and medical devices after the end of the transition period. Read more “Catch the latest updates to the MHRA transition period guidances”
New IRIS platform for EMA scientific advice
From 19 October 2020, drug developers will have to use the European Medicines Agency’s (EMA) IRIS Regulatory & Scientific Information Management Platform to request scientific advice. Read more “New IRIS platform for EMA scientific advice”