GMP News - Pharmaceutical Development / Clinical Trials / GCP

ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".

The EMA has announced a new timeline for the application of the Clinical Trials Regulation due to EMA`s move to Amsterdam because of the Brexit.

The FDA published a draft guidance on Data Integrity in clinical studies of veterinary medicinal products to support new animal drug applications. Read more about the documentation of  Electronic Data Files and Statistical Analysis Programs.

The US Food and Drug Administration (FDA) recently made available the ICH Q12 draft guidance on "Product Life Cycle Management" together with its Annex.

The UK Government recently confirmed that it is committed to implementing the EU CTR into UK law to the extent possible after Brexit.

The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules. Read more about impact of the new EU Data Protection Regulations on clinical trial and pharmacovigilance activities.

The final USP General Chapter <1210> has been published. It will become official on May 1, 2018. Read more about  Statistical Tools for Procedure Validation.