GMP News - Pharmaceutical Development / Clinical Trials / GCP

The USP published a stimuli article containing the Highlights of the US Pharmacopeia (USP) and ECA Academy Workshop on the Lifecycle Approach of Analytical Procedures.

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.

The ICH E11 Addendum reached Step 4 of the ICH Process and now enters into the implementation period. Read more about ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population.

The USP has recently undertaken an in-depth review of chapter <381> which has resulted in significant revisions especially to the heavy metals and functionality tests. In a stimuli article the USP now provides the rationale for the proposed changes to USP general chapter Elastomeric Closures for Injections <381>.

The EU Commission published two new GMP documents in the Official Journal of the European Union. Learn more about the GMP Directive 2017/1572 for medicinal products for human use and the Delegated Regulation 2017/1569 on GMP for investigational medicinal products (IMPs) and requirements for inspections.

The European Medicines Agency, EMA, announced a new timeline in its press release dated 6 October 2017. According to this, the EU GCP Regulation will be applied mid-2019 at the earliest.

The International Council for Harmonisation (ICH) recently published its proposed E9 Addendum to define the appropriate estimand for a clinical trial. Read more about the draft E9(R1) Addendum: Statistical Principles for Clinical Trials.