All European Medicines Agency (EMA) articles – Page 4
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JournalA critical review and comparison of the processes when seeking Scientific Advice in the EU and the USA – Part 2
GRAY, MSc − PART TWO OF A TWO-PART SERIES(See part 1 here) Scientific Advice (SA) is provided by all major regulatory agencies to pharmaceutical companies and other interested parties who are developing new medicines. Regulatory agencies such as EMA and FDA regard provision of SA as a ...
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Industry newsGood safety profile of COVID-19 vaccines declared by ICMRA
COVID-19 vaccines show a very good safety profile in all age groups, including people with underlying medical conditions and pregnancy.
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VideoEuropean Parliament gives first stage approval for revised EMA fees
MEPs in Strasbourg follow the parliament’s health committee’s approval of report to revise how EMA charges.
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JournalG-E-T-ting there – how gene editing technologies could change more than genes
The field of genome editing technologies (GETs) is rapidly advancing, marking a new and exciting era of curative medicines. These products can alter genetic material in patients, highlighting the crucial need to introduce dedicated legislation to ensure that GETs are developed and maintained in a safe and effective manner.
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JournalConsiderations for sponsors when producing an EU IMPD: Impact of the EU-CTR
European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.
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