Lone Cleveland Andersen Keep up to dates with all news from The Danish Medicines Agency and EMA, as news and new knowledge are uploaded at The Danish Medicines Agency and EMA sites frequently. Links to news are as follows: Danish Medicines Agency EMA – European Medicines Agency Links … Read more
EMA has published a new Guidance on the sterilization of the medicinal product, active substance, excipient and primary container. The purpose of this document is to provide guidance on the selection of appropriate sterilization methods for sterile products. In general, terminal sterilization according to the … Read more
In the last two years, national competent authorities from all over the world have focused more and more on Data Integrity. Different authorities have published draft guidelines: In April 2016, the FDA issued a first draft Guidance for Industry, “New FDA Draft Guidance Data Integrity and … Read more
With the publication of the new GDP Guideline in 2013 the legal requirements concerning the Good Distribution Practice increased throughout the complete legal distribution chain from manufacturing and release to distribution to the patient. The competent supervisory authorities carry out GDP inspections of companies that … Read more