This overview is based on MHRA webinar from 5th of May 2025. The new UK national procedure for marketing authorisations became effective on 3 April 2025. There are differences in…
Continue readingWe would like to bring to your attention several articles which we recently published on LinkedIn and which highlight the benefits of conducting clinical trials in the UK. Why the…
Continue readingThere are a lot of pilots that MHRA started back in 2023. This is a short summary of the new initiatives and how they can be helpful for pharma and…
Continue readingExpedited approvals in Japan Japan is one of the leading countries in Asia when it comes to obtaining marketing authorisations and conducting research. Similar to other countries Japan has different…
Continue readingDo you have product developed in China? This could be new therapy, medical device, cosmetics, food supplements and many more. Are you planning to submit clinical trial in UK but…
Continue readingInternational The International Council for Harmonization (ICH) are preparing new guidelines for analytical methods used by manufacturers for testing medicines post approval. According to the feedback from ICH the purpose…
Continue readingEurope EMA has released a new initiative called ‘Accelerating Clinical Trials in the EU (ACT EU)’. According to the paper it will adapt some of the methods used in COVID…
Continue readingUSA A study looking into RWD from 50 post-approval confirmatory studies requested by FDA shows that data is inconclusive and difficult to analyse. The authors mentioned that some of the…
Continue readingUSA FDA has issued a new draft guideline for safety reporting which is expected to be finalised in Nov 2021. In the new edition they acknowledge that clinical trials are…
Continue readingFDA extended access program started back in 2009 and it allowed patients with life-threatening diseases who have exhausted all other options to try experimental drugs, which are not on the…
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