Regulator Spotlight
At a late March meeting of the African Medicines Regulatory Harmonization (AMRH) Steering and Technical Committees, a press briefing was held to announce the first continental listing of medicinal products that have undergone assessment and inspection by African regulators and highlight its significance as a milestone in the AMRH effort to enable more efficient approval timelines and faster access to African patients. Participating in the briefing were: ● SAHPRA CEO Boitumelo (Tumi) Semete-Makokotlela, who chairs the AMRH Steering Committee ● AUDA-NEPAD AMRH Head Chimwemwe Chamdimba ● Cameroon Assessor Aude Perine Minyem Ngombi, who chairs the Evaluation of Medicinal Products Technical Committee (EMP-TC) ● SAHPRA Inspectorate Head Wayne Muller, the chair of the GMP-TC, and ● EMA International Affairs Head Martin Harvey. The briefing was moderated by AUDA-NEPAD Regulatory Systems Strengthening Program Officer Alex Juma Ismail.
CLICK HERE to view the issue.
ABOUT THE WEEKLY SUPPLEMENT
Along with a feature story on a presentation or panel discussion at a conference in which leading regulators address the challenges and developments in a key area of concern, our Weekly Supplements include a summary listing of the “Updates in Brief,” drug GMP warning letters and recalls, and EMA non-compliance reports that have been posted on IPQ’s website during the week. Subscribers can then click through to the full posting.
Also provided, where applicable, are links to the parts of in-depth stories and Monthly Updates that have been released during the week.
Appended to the issue is a chronological listing of the headlines of the featured regulator stories since IPQ began its Weekly Supplement series in February 2024. Also appended are the headlines of the in-depth stories that IPQ has released since 2020. Those of especially high relevance to the regulator insights provided in this issue are indicated with a red star. Click on the headlines to access the stories.