MCA MCA-GL-501,MCA-GL-501, version 4
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MCA-GL-501, version 4 is the official MCA identifier for “Guideline for Clinical Trials in Humans”. MCA-GL-501, version 4 is the official identifier MCA uses for this instrument.
- Instrument
- MCA-GL-501,
- Full name
- MCA-GL-501, version 4
- Category
- Clinical Trials
- Source publication
- English
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guideline for Clinical Trials in Humans
MCA clinical-trial guideline version 4, dated 24 February 2025. Its investigational-product definition expressly includes medical devices and diagnostics. Covers common trial authorisation, ethics and consent, amendments, trial-related import/export, safety reporting, notifications and record retention, with three flow charts and three appendices. Medicine-phase, IMP and drug-safety branches retain their original product-specific qualifications and are not general device obligations. The cover lists version 4 Effective Date as 21 February, approval as 24 February and coming into effect as 26 February 2025; no effective date is inferred. Present validity and incorporated dependencies remain unverified.
MCA-GL-501, version 4 is the official identifier MCA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.