medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
Last updated: 1 July 2022 See updates at the end of the post. 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…
This post is an attempt to provide basic information about paediatric investigation plans (PIPs) in the EU. The information provided is by no means exhaustive. Click on the ‘+’ sign next to each heading to access the information under each…
The European Medicines Agency (EMA) has provided guidance to MAHs on last submission dates for Type I and II variations for human medicines, in 2021. (MAHs) are advised to submit variations as follows: Variation type To be submitted no later than…
Last updated: 21 December 2021 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…
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 European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for: hybrid products (EMA) and abbreviated new drug applications…
The EU Simultaneous National Scientific Advice (SNSA) pilot has been extended to the end of 2021 due to the COVID-19 pandemic, in order to allow additional experience to be gained. About the SNSA pilot The EU Innovation Network started a…
The European Medicines Agency has recently published a 29 page Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation holders (MAHs). Whilst it is recognised that many MAH companies are not directly engaged in the manufacture of medicinal products…
The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…
There are currently a couple of EU clinical trials related guidelines under consultation. Both guidelines must be considered in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came…