Read this post from the Health Products Regulatory Authority (HPRA):ICMRA is inviting manufacturers to join two pilot programmes, which aim to improve manufacturing capacity for critical medicines and facilitate collaborative inspections by multiple regulatory authorities.
The first pilot will focus on a multi-region collaborative assessment of Chemistry and Manufacturing Control (CMC) submissions. It aims to establish a single list of questions and a single outcome when submitting a CMC change to several regions.
The second pilot programme aims to develop streamlined approaches for hybrid multi-agency inspections of facilities.
To apply to participate in one or both pilots, visit the ICMRA website. The first pilot is due to begin in September 2022.
The from the HPRA is here.
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