Dirección General de Medicamentos, Insumos y Drogas
Peruvian regulator; its GMP manual for pharmaceutical products was approved by Decreto Supremo 021-2018-SA.
WHAT DIGEMID COVERS
The Dirección General de Medicamentos, Insumos y Drogas is Peru’s medicines regulator, part of the Ministry of Health. Its Manual of Good Manufacturing Practices for pharmaceutical products was approved by Decreto Supremo N° 021-2018-SA, which also amended the regulation covering registration, control, and sanitary surveillance.
WHERE IT SITS INTERNATIONALLY
Peru’s framework is grounded in WHO GMP guidance, which is the practical bridge for manufacturers already compliant with WHO or PIC/S standards. For exporters and distributors serving the Andean market, the efficient route is to build one WHO-GMP-anchored evidence pack and adapt it per country, rather than treating each regulator as a separate system.
HOW ITS REQUIREMENTS BITE
DIGEMID grants sanitary registration and inspects manufacturers against the WHO-based GMP manual, certifying compliance for products supplied to the Peruvian market. Foreign manufacturers are generally required to evidence GMP compliance acceptable to DIGEMID as part of registration.
WHAT DIGEMID PUBLISHES
- 01The GMP manual approved by DS 021-2018-SA
- 02Registration and sanitary surveillance requirements under the amended regulation
- 03GMP certification outcomes
- 04Health alerts and pharmacovigilance communications
- 05Technical directives issued by the Ministry of Health
WHAT PRACTITIONERS GET WRONG
- ›The manual is WHO-GMP based, so sites compliant with WHO or PIC/S expectations align closely; the work is evidencing that alignment in the form DIGEMID accepts.
- ›Verify the current consolidated text and any later amendments before relying on a copy — supreme decrees are amended by later decrees rather than reissued.
- ›Spanish-language documentation is expected, and a certificate issued by a foreign authority normally needs legalisation or apostille to be accepted.
- ›Registration and GMP evidence are coupled — treat them as one workstream, not two, because a registration dossier stalls on missing GMP evidence.
- ›Peru participates in regional convergence work through PANDRH, so expect its expectations to track WHO and PIC/S rather than diverge.
DIGEMID STANDARDS SPEQ DECODES · 1
DISCIPLINES IN DIGEMID’S REMIT
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