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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

After a public consultation last July, the EMA published its Reflection Paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAH) on 23 July 2021. The Paper aims to clarify the responsibilities of the MAH in the GMP guidelines and the applicable legislation. While it is not legally binding, the EMA expects competent authorities to use the Paper as guidance when performing inspections, and so MAHs should familiarise themselves with the document. In this blog we have summarised the key takeaways.
Continue Reading EMA Reflection Paper on Good Manufacturing Practices and Marketing Authorisation Holders