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Reforma parcial de la Resolución ARCSA-DE-008-2018-JCGO a través de la cual se expide la "Normativa Técnica Sanitaria Sustitutiva de Buenas Prácticas de Manufactura para Laboratorios Farmacéuticos", Publicada en Registro Oficial N.° 257, de 07 de junio de 2018 (Partial amendment of Resolution ARCSA-DE-008-2018-JCGO issuing the Substitute Technical Health Regulations on Good Manufacturing Practices for Pharmaceutical Laboratories, published in Official Journal No. 257 of 7 June 2018).

The notified draft regulations seek to update the certifying process under the good manufacturing practices for domestic and foreign pharmaceutical laboratories that manufacture and/or market medicaments, biological products, radiopharmaceuticals, active pharmaceutical ingredients and early-stage pipeline products, in the Ecuadorian territory.