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The EMA has published a revised version of its list of relevant guidelines with regard to the contents of an SmPC. Read more about the document entitled "Scientific guidelines with SmPC recommendations".
The EMA recommends the suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs. Medicines where suitable alternative data are available can remain on market. Read more about the press release regarding medicines recommended for suspension.
The Implementing Regulation (EU) 2017/556 has been published in the Official Journal of the European Union on 25 March 2017. Read more about the details set regarding good clinical practice inspections of clinical trials.
On 2nd March 2017, the US FDA and the European Medicines Agency (EMA) informed that they concluded a so-called MRA (Mutual Recognition Agreement). Learn more about the FDA-EU MRA and the consequences for the Qualified Person (QP).
Recently published, the EMA Guideline on the implementation of the requirements of the ICH Q3D Guideline provides support for API and medicinal product manufacturers. Learn more about what you have to consider with regard to the justification and documentation of elemental impurities in the dossier for a marketing authorisation.
According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use".