European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into force from 31 January 2023. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. The EU Clinical...
The European Medicines Agency (EMA) has released a draft guideline on the medical device quality requirements for drug–device combinations (medicines that include a medical device). The guideline (dated 29 May 2019) addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in...
EMA has recently published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices . The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain...
On 1st of Feb. 2019 the FDA announced the availability of draft guidance "Rare Diseases: Common Issues in Drug Development". This guidance revises and replaces the previous draft guidance of the same name from 2015. Comments and suggestions regarding this draft document should...
The sponsor should ensure that all trial-related tasks, which are outsourced to the contract research organisation (CRO)/vendor, are carried out in accordance with the protocol, written agreements, GCP and local requirements. Especially, when the trial tasks are outsourced to different CROs/vendors at the same time,...
Trial master file (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors and inspectors to evaluate compliance with the...
