The European Medicines Agency (EMA) regularly updates the "Questions & Answers (Q&A)" documents on its website relating to centralised marketing authorization procedures. Now, a catalogue with Q&As exclusively on the topic of "Organisation Management Service (OMS)" has been published on the EMA's eSubmission website.
In October and November, the European Medicines Agency (EMA) once more published on its website the updated and revised version of the "Questions & Answers (Q&A)" document related to questions prior to and during the submission of a centralised procedure.
As a result of the increased demand for disinfectants, especially for hand hygiene, the number of inferior products with deficiencies in composition and/or approval is increasing rapidly. This is accompanied by an increase in Warning Letters from the FDA to disinfectant manufacturers.
In October, the WHO published a draft revision of the Guide for the Safe Production and Quality Control of Monoclonal Antibodies. It is a continuation of the guidance documents on this topic that have already existed since 1991.
As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.
With Dr Robert Califf, President Biden has now nominated an expert in clinical trials who has previously served as an FDA Commissioner.
EMAs HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement?
The Commission Implementing Regulation (EU) 2021/1280 lays down the good distribution practices for active substances used as starting materials in veterinary medicinal products. It applies to importers, distributors, and manufacturers. The Regulation has been binding since August 2021 and is directly applicable in all Member States. We have summarised the most important requirements of the new Regulation.
In light of ongoing difficulties to conduct on-site GDP inspections due to restrictions arising from the COVID-19 pandemic, GDP certificates and time-limited wholesale authorisations for sites in the European Economic Area (EEA) are automatically extended until the end of 2022.
Do you know that many supporting documents are available free of charge in the member's area of the European GDP Association? To get an idea, take a look here.