The European Medicines Agency (EMA) have released a guidance document addressing a number of questions that users of the scientific advice or protocol assistance procedures may have. Read more “EMA guidance on scientific advice and protocol assistance”
News
UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium
From 01 January 2021, pharmaceutical companies that submit applications to some or all of the five countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times. Read more “UK MHRA to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium”
European Commission strategy for effective COVID vaccine rollout
The European Commission (EC) has laid out key steps in a strategy for effective COVID-19 vaccine deployment in Member States (MS). Read more “European Commission strategy for effective COVID vaccine rollout”
EMA Mid-year report 2020
The European Medicines Agency (EMA) has published its mid-year report for 2020.
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”
MHRA issues post-transition orphan medicine guidance
The Medicines and Healthcare product Regulatory Agency (MHRA) explains that it will provide incentives to encourage the development of products to treat rare diseases, including market exclusivity, refunds for marketing authorisation fees and scientific advice fee waivers for UK-based small and medium enterprises (SME). Read more “MHRA issues post-transition orphan medicine guidance”
Guidance on supplying medicines to Northern Ireland post-transition
What do you need to do to supply authorised medicines from Great Britain (GB) to Northern Ireland (NI)? Read more “Guidance on supplying medicines to Northern Ireland post-transition”
Implications for Medical Device Usability Engineering following amendments to IEC 62366
International Standard IEC 62366-1: Application of usability engineering to medical devices, was updated and published in June 2020. Read more “Implications for Medical Device Usability Engineering following amendments to IEC 62366”
Draft guidance on registry-based studies
The European Medicines Agency (EMA) has addressed the used of registry-based studies in pre-and post- authorisation phases for medicines. Read more “Draft guidance on registry-based studies”
‘Brexit Readiness Checklist’ for companies doing business with the UK
The European Commission (EC) has published a Brexit Readiness Checklist in anticipation of the end of the transition period on 1 January 2021. Read more “‘Brexit Readiness Checklist’ for companies doing business with the UK”