August 23, 2022
The European Medicines Agency (EMA) is supporting the European Union's (EU) response to the monkeypox outbreak. It is in close contact with medicine developers and its partner organisations in the EU...
August 22, 2022
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study
Orphan Designation of ATMPs for Rare Diseases: MPS II Case Study Many advanced therapy medicinal products (ATMPs) in development in the EU are for rare diseases and conditions. Since the...
August 19, 2022
EMA’s Emergency Task Force advises on intradermal use of Imvanex / Jynneos against monkeypox
August 19, 2022 EMA’s Emergency Task Force (ETF) has reviewed data on the monkeypox vaccine Imvanex 1 used as an intradermal injection (given just below the top layer of the skin). The vaccine is...
August 10, 2022
EMA COVID-19 guidance: research and development
The European Medicines Agency (EMA) provides support to medicine developers researching and developing potential COVID-19 medicines. Dedicated guidance, rapid procedures and contact points are...
August 8, 2022
Early engagement with Health Technology Assessment authorities will accelerate product launch and improve chances for reimbursement
Pharmaceutical companies should understand EU Health Technology Assessment (HTA) authorities requirements early in the product development phase. Engagement with HTA authorities during clinical...
August 3, 2022
EMA: List of centrally authorised products requiring a notification of a change for update of annexes
August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...
August 1, 2022
UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??
If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...
July 29, 2022
EMA: Big data use for public health: publication of Big Data Steering Group workplan 2022-25
News July 28, 2022 The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–25. The new...
July 28, 2022
Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Introduction - EU Implemen
The Europe Introduction - EU Implementation Guide has been prepared by the European Medicines Agency (EMA) upon consultation with different stakeholders (representatives of marketing authorisation...