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Public consultation on ICH E6(R3) Guideline on good clinical practice (GCP)
On 26 May 2023, the European Medicines Agency (EMA) published the draft ICH E6 (R3) guideline on good clinical practice (GCP) – step 2b and the template for comments to the ICH E6 (R3) guideline on good clinical practice. The document has been submitted for public consultation and the comments will be collected until September […]
CEP 2.0 as new certification form issued by EDQM for demonstrating substance used in the preparation of medicinal products compliance with the European Pharmacopoeia
The CEP, as you know, is a “Certificate of suitability to the monographs of the European Pharmacopoeia“. As we can read on the EDQM (European Directorate for the Quality of Medicines and HealthCare) website it is not mandatory, but the preferred option for demonstrating that a substance used in the preparation of medicinal products complies […]
RAPS: New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India
The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March. The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system […]
EMA: Regulatory cooperation to improve global health
EMA experts meet with African regulators to discuss opportunities for collaboration. How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency […]