USP-NF Stimuli Article on Quality by Design (QbD) Principles in Method Development
In the Pharmacopeial Forum, PF 49(1), a stimuli article entitled "A Novel Approach Using Quality by Design to Develop and Implement Flexible Methods in Non-Application Over-the-Counter Monographs" was published.
ANVISA authorizes National Scientific Research with Cannabis
The agency now authorizes national scientific research with cannabis-derived products. The authorization granted will allow to conduct pre-clinical research to evaluate the efficacy and safety of cannabinoids in the management of signs and symptoms associated with neurological and psychiatric disorders.
Clinical Trials: EMA clarifies Dates for the Transition Period
In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. Following the previous update on how to manage clinical trials transitioned to the CTR, the EMA now clarifies the timelines for the transition period.
How to Manage Clinical Trials Transitioned to the CTR?
In order to help sponsors using the CTIS, the EMA has published a sponsor handbook. The EMA is continuously updating the CTIS Sponsor Handbook with further priority topics and a revised version 3 has now been published.
Sponsor Responsibilities with regard to Handling and Shipping of IMPs
Following the entry into application of the CTR at the beginning of last year, the final version of the "Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMPs" has been published. IMPs may not be used in a clinical trial in a member state of the European Union until the completion of the two-step procedure referred to in this guideline.
Update on the EMA Guidance for Applicants/MAHs involved in GCP Inspections
The EMA published the revised Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA. By this revision only the GCP section of the document has been amended. Amongst others it has been clarified that the reporting inspector should be contacted prior to submitting any documents.
Clinical Trials Regulation - Version 6.2 of the Q&As
The European Commission published an updated Version of the Questions & Answers relating to the EU Clinical Trials Regulation. What are patient facing documents and how are these documents expected to be submitted ?
Following the delayed 2019 Annual Report of the Good Clinical Practice Inspectors’ Working Group (GCP IWG) published earlier this year, the EMA released the 2020 and 2021 annual GCP reports. An increase in findings related to computer systems is noted compared to the last reports.
The European Commission (EC) amended the current requirements provided in the Clinical Trials Regulation (CTR) for the labelling of investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation.
The European Medicines Agency has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and will help to identify suitable RWD sources.