The CMDh has revised and published its Q&A document on the QP Declaration.
In December 2021, the European Medicines Agency (EMA) published the draft guideline "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website.
The new USP general chapters <665> and <1665> have now finally been approved. Chapter <665> establishes a baseline for the qualification of plastic components used in the manufacturing of pharmaceutical and / or biopharmaceutical drugs.
Wholesale trading of medicinal products in Germany requires an authorisation according to Section 52a of the Medicinal Products Act (Arzneimittelgesetz AMG). The holder of the authorisation must notify the competent authority in advance of any fundamental changes. A wholesaler from Brandenburg, Germany, did not comply with this notification requirement, as a GDP Non-Compliance Report published in October 2021 shows.
Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.
A new USP chapter <1567> on pyrrolizidine alkaloids (PAs) is being proposed. It discusses some analytical methods and existing challenges to measure PA contaminants in herbal medicinal products.
Because there is no existing USP monograph for this drug substance, a new monograph for Cannabidiol (CBD) is being proposed. It defines that CBD is obtained from Cannabis sativa.
In order to ensure that medicinal products continue to be marketed with a unique identifier (UI) in Northern Ireland, Cyprus, Ireland and Malta, the Commission further extends the temporary derogation from the requirement to decommission UIs of products exported to UK.
In the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> was published. According to the Expert Committee, the aim of the new chapter is to provide an overview of the minimum quality attributes required for starting materials used in the manufacture of synthetic therapeutic peptides.
A revised draft for the new Ph. Eur. chapter 3.1.17. Cyclo-Olefin Copolymers (COC) has been published for comment in Pharmeuropa.