latest news

EU GMP Annex 21 finally published

On 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled “Importation of medicinal Products”. The “Concept Paper” was already

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EMA on potential Impact of Coronavirus

The European Medicines Agency (EMA) and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on

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Brexit: MRA will be needed soon

Three European Industry Associations (EFPIA, Medicines for Europe and AESGP) have published a “Call for a Mutual Recognition Agreement on Good Manufacturing Practice (GMP) in the Context of Ambitious and

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Annex 1: Consequences for the QP

On February 20, the long-awaited revised draft of Annex 1 (Manufacture of Sterile Products) was published. The revised Annex 1 will not be an independent EU document, but should also apply

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