News - July 21, 2023
On 18 July, European lawmakers within the Health and Environment (ENVI) committee voted to adopt the amended report on Substances of Human Origin (SoHo). The report aims to improve the safety and quality standards for both donors and recipients of blood, plasma, skin, embryo, sperm,… read more
News - March 17, 2023
The European Medicines Agency (EMA) has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)). As of… read more
News - December 16, 2022
Sounds of Science Podcast – Episode 10 Launch Conditionality: The impact on small and mid-sized companies Within the European Commission’s ongoing review of the General Pharmaceutical Legislation and Orphan Medicinal Products (OMP) Regulation, there are several potentially controversial policy options that aim to enhance access… read more
News - December 17, 2020
Published on 8 December, the European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) Joint Strategy looks into six strategic focus areas: (1) Availability and accessibility of medicines, (2) Digital tools and digital transformation, (3) Innovation, (4) Antimicrobial resistance, (5) Supply chain challenges, and… read more
Events & Meetings / News - November 27, 2020
On 30/11, the European Medicines Agency (EMA) will organise a virtual event to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. The meeting will highlight and explain existing tools in the context of early product development strategy…. read more
News - May 29, 2020
As part of the collective response to COVID-19, a significant number of clinical trials are underway in an attempt to identify potentially effective COVID-19 treatments and bring them rapidly to patients. The EMA has published guidance documents on EMA initiatives for the acceleration of development… read more
News - May 5, 2020
The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every… read more
News - April 14, 2020
The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic. The Q&A document includes information on… read more
News - April 3, 2020
The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic. The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants,… read more
News - November 18, 2019
As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated and collaborative regulatory framework.
