Clinical research on large scale
European Union pharmaceutical legislation, the Clinical Trial Regulation, entered into application on 31 January 2022. It aims to ensure the European Union offers an attractive and favorable environment for conducting clinical research on a large scale, with high public transparency and safety standards for clinical trial participants. On 31 January 2022, the regulation replaced the Clinical Trial Directive (EC) No. 2001/20/EC and national implementing legislation in the member states that regulated the Clinical trials in the European Union before the regulation application. The clinical trial regulation uniforms the assessment and supervision of clinical trials throughout the European Union. Earlier before the implementation of the regulation, the sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to obtain approvals to conduct clinical trials. This regulation enables one single online application via an online platform called Clinical Trials Information System for approval to run a clinical trial in several European countries. It also enables the member states to evaluate the clinical trial application. The fundamental purpose of the regulation is to foster innovation and research in the European Union and support the conduct of more extensive clinical trials in multiple European Union member states. Some other key benefits of the regulation include improving information sharing and collective decision-making on clinical trials, increasing transparency of the information on clinical trials, and ensuring high safety standards for all participants in European Union clinical trials. The clinical trial sponsors can use the Clinical Trials Information System from 31 January 2022 but are not obliged to use it immediately, in line with a three-year transition period. The system enables the sponsors to apply for clinical authorization in up to 30 European countries with a single online application. Allows national regulators to analyze and assess the clinical trial application. Until 30 January 2023, the sponsors are provided with transition time, and from 31 January 2023, clinical trial sponsors will need to use Clinical Trials Information System to apply to start a new clinical trial in the European Union. Respond to this discussion post in a positive way in 5-7 sentences


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