MCAZ MCAZMCAZ/EDA reliance framework
MCAZ/EDA reliance framework is the official MCAZ identifier for “Recognition Framework for Medicines Manufactured in Egypt and Approved by the Egyptian Drug Authority (EDA)”. MCAZ/EDA reliance framework is the official identifier MCAZ uses for this instrument.
- Instrument
- MCAZ
- Full name
- MCAZ/EDA reliance framework
- Category
- Registration
- Authority source
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Recognition Framework for Medicines Manufactured in Egypt and Approved by the Egyptian Drug Authority (EDA)
MCAZ's reliance framework for products approved by the Egyptian Drug Authority, arising from the Zimbabwe-Egypt cooperation agreement of March 2023 and built on the WHO SRA collaborative registration procedure. It lists the documents an application must carry (EDA-endorsed Quality Information Summary, CTD dossier, cGMP confirmation, labelling, fee), then splits the work between the manufacturer, EDA and MCAZ, and sets MCAZ's 30-day assessment target. Two things about this document matter to a reader and are stated rather than worked around. First, it is a MEDICINES-ONLY framework: the word "device" does not appear anywhere in it, and the fee table is keyed to generic, new chemical entity and line-extension medicines applications. It is ingested because it is the reliance instrument MCAZ publishes, and it is relevant to a device reader only as evidence of the authority's reliance posture, not as a device route. Second, it is a Word document that states no version, no publication date and no effective date; the only date connected with it, 01.06.2023, appears in its file name and nowhere in its text.
MCAZ/EDA reliance framework is the official identifier MCAZ uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.