Clinical Trials Regulation

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In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human use (the Policy). The Policy, as discussed in previous posts, is one of the Agency’s flagship public health initiatives focused on promoting the transparency of both EMA decision-making and clinical data, sharing of knowledge and use in future research.

While the Policy was adopted by the EMA back in 2014, it has been suspended since 2018 due to the EMA’s relocation to Amsterdam and COVID-19. During the COVID-19 pandemic, the EMA adopted exceptional transparency measures for centrally approved COVID-19 vaccines and treatments. This was deemed a success further showing the need for clinical data sharing and, thus, the need  for relaunching the Policy.Continue Reading EMA relaunches Policy 0070 on publication of clinical data for medicinal products for human use

As part of the strategy to fight COVID-19, the European Commission has proposed a Regulation to facilitate the conduct of clinical trials using medicinal products containing or consisting of Genetically Modified Organisms (GMOs).

The European Commission recognises that the applicable regulatory framework in relation to GMOs is unable to adequately address the challenges created by the pandemic. While some vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of a GMO, there is uncertainty on the interactions between the GMO regulatory framework and the legislation on clinical trials and medicinal products. This is further aggravated by the absence of a common approach by the EU Member States.
Continue Reading The European Commission proposes a Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs

On 11 June 2020, the European Medicines Agency (EMA), during its Management Board meeting, has endorsed the methodology and next steps leading to the go-live of the Clinical Trials Information System (CTIS) which is now fixed for December 2021. A group consisting of representatives of the EU Member States and the European Commission has been set up to prioritise and coordinate all outstanding issues prior to go-live. The CTIS is the centralised EU portal and database for information storage foreseen by the Clinical Trials Regulation.  
Continue Reading EU Clinical Trials Regulation: The Clinical Trials Information System expected to go live by December 2021, according to the EMA