IMP Public Consultations

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] The EU Commission has published four new public consultations on investigational medicinal products (IMPs) covering both GMPs and GCPs for human medicinal products: ● the “commission delegated act on principles and guidelines on good manu-facturing practices for investigational medicinal products for human use and inspection procedures” seeks stakeholder feedback on eight questions and includes a new requirement for regulatory inspections of IMP manufacturers located in third countries to document that the GMPs are equivalent to those in the EU ● the “detailed commission guidelines on good manufacturing practices for investigational medicinal products” complement and expand on the delegated act ● the “commission implementing act on principles and guidelines on good manufacturing practice for medicinal products for human use” seeks input from stake-holders on implementation, and ● the “detailed arrangement for clinical trials inspection procedures including the qualifications and training requirements for inspectors,” which seeks input on the topic described in the title. The consultation period ends on November 24.
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