On 20th March 2020 the EU-GMP Guideline of Annex 21 ‘Importation of Medicinal Products’ was published as a draft. In addition to the guidance outlined in the main chapters and annexes, it was a thought that there was a need to publish a specific guideline on importation of medicinal products under a dedicated annex of
Read more
On 31st of December 2019, a cluster of pneumonia cases with unknown aetiology were reported in Wuhan, China. At the time, healthcare professionals could not identify the causative agent for these seemingly related incidents but on the 7th of January the Chinese authorities confirmed a novel coronavirus (nCoV) was responsible for the disease. This virus
Read more
An Overview of Rare Diseases: On February 29th, 2020 the world will observe Rare Diseases Day coordinated by the European Organisation for Rare Diseases (EURODIS). Now in its 13th year, this special day aims to spread awareness of rare diseases and the patients whose lives are impacted by them. But what exactly is a rare
Read more
With the rise of new therapeutic modalities, regulators have had to adapt to the changing environment and one of these adaptions is through the introduction of Advanced Therapy Medicinal Products (ATMPs). This article highlights some of the key considerations of working with ATMPs.
Read more
The United Kingdom (UK) voted in a referendum on June 23rd, 2016 to leave the European Union (EU), by 52% to 48%, leaving the Single Market and the Customs Union. While the referendum was not legally binding, the UK government at the time promised to honour the result. The UK has population of over 66
Read more