EU reveals new regulations on clinical trials

EU reveals new regulations on clinical trials
Gavi Vaccine Alliance
Sunday 30 January 2022 - 00:53

A new regulation aimed at improving clinical trials in the EU will come into force on January 31, the European Commission said on Friday.

Under this new regulation, the assessment and oversight of clinical trials will be harmonized across the EU, including through a Clinical Trials Information System, managed by the European medicines, says the Commission.

According to the EU executive, this includes improving the conduct of clinical trials in the EU by ensuring the highest safety standards and increasing the transparency of information.

“ The entry into force of the Clinical Trials Regulation marks an important milestone for European patients and further strengthens the European Health Union. This regulation will allow clinical trials to be authorized more quickly in our Member States, and therefore improve the efficiency of clinical research while maintaining the high quality and safety standards already in place,” said Stella Kyriakides, Commissioner European Union responsible for health and food safety.

With almost 4,000 clinical trials carried out each year in the EU, she added, this regulation will facilitate research activities for researchers and patients, who depend on fast and reliable tests.

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