Instituto de Salud Pública de Chile (ANAMED)
Chilean regulator (ANAMED sub-department); applies GMP through Norma Técnica N° 127.
WHAT ISP COVERS
The Instituto de Salud Pública de Chile is the national regulator for medicines, with its ANAMED sub-department (Agencia Nacional de Medicamentos) responsible for authorisation and control. GMP is applied through Norma Técnica N° 127, approved by Decreto Exento N° 28 of 2012 and updated by Decreto Exento N° 159 of 2013, under the pharmaceutical control regulation DS N° 3 of 2010.
WHERE IT SITS INTERNATIONALLY
Chile’s GMP standard is grounded in WHO GMP reports, and ISP has been designated a WHO-Listed Authority, which supports reliance by other regulators in the region. For a supplier or contract manufacturer already inspected against WHO or PIC/S expectations, the Chilean requirement is recognisable — the effort is in local certification, translation, and evidencing that foreign compliance in a form ISP accepts.
HOW ITS REQUIREMENTS BITE
ISP certifies GMP compliance following on-site inspection, examining facilities, equipment, and daily process records. Certification supports product registration for the Chilean market, and foreign manufacturers must evidence compliance acceptable to ISP.
WHAT ISP PUBLISHES
- 01Norma Técnica N° 127 — the GMP technical standard
- 02Registration and authorisation requirements under DS N° 3/2010
- 03GMP certification outcomes for inspected laboratories
- 04Pharmacovigilance and safety communications
- 05Technical standards covering specific product categories, including advanced therapies
WHAT PRACTITIONERS GET WRONG
- ›Work from the Decreto Exento N° 159/2013 update of Norma Técnica N° 127, not the 2012 original — the update is the text inspectors apply.
- ›The standard follows WHO GMP (Reports 32/33, updated per Report 37), so a WHO- or PIC/S-compliant site aligns closely on technical substance.
- ›ISP certification follows on-site inspection of facilities, equipment, and daily process records — records, not just systems, are examined.
- ›Spanish-language documentation is expected, and foreign GMP evidence generally needs legalisation to be accepted.
- ›ANAMED sits inside ISP rather than operating as a separate agency, so medicines authorisation and public-health laboratory functions share one institution.
ISP STANDARDS SPEQ DECODES · 1
DISCIPLINES IN ISP’S REMIT
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