Sentence examples for trials regulation from inspiring English sources
Take the clinical trials regulation, cited previously by Brexit supporters.
The outcome "could potentially affect clinical trials regulation worldwide," the announcement said.
The XWP was also expanded to include new members with expertise in animal welfare, clinical trials regulation and the management of infectious diseases (XWP 2003a, para 1.18).
In the EU, some clinical associations, such as the European Association for Cancer Research, had actively lobbied for the improvement of EU clinical trials regulation.
EMA and the European Parliament, which approved the new European clinical trials regulation on 2 April 2014, have received praise for their leadership on facilitating access to clinical study reports.
Recently the committee of representatives from every EU member state government agreed with the text of the Clinical Trials Regulation, which includes the proposal of a publicly accessible EU database, set up and run by the EMA, containing clinical study reports for new trials, when applicable, starting from 2014, used in a marketing authorisation request.
9 In the UK, investigational products, such as unlicensed medications and vaccines, are regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004 which implement the European Clinical Trials Directive (2001/20/EC).
bIn UK for instance, the Medicines for Human Use (Clinical Trials) Regulations 2004 refer explicitly to the 'ethical principles that have their origin in the Declaration of Helsinki' (Schedule 1, pt. 2, para. 1).
Labelling, storage and preparation will be done according to the requirements of the Medicines for Human Use (Clinical Trials) regulations.
In accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and Directive 2001/20/EC, the drugs under investigation in this trial fall under the definition of 'investigational medicinal product' (IMP).
Clinical trials of cell-based medicinal products are regulated by the Medicines and Healthcare Products Regulatory Agency in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (MHRA, 2004a ).
