WTO notification · TBT
EcuadorAdopted, according to its latest notice
Partial reform of Resolution ARCSA-DE-008-2018-JCGO through which the 'Substitute Sanitary Technical Regulation of Good Manufacturing Practices for Pharmaceutical Laboratories' (Normativa Técnica Sanitaria Sustitutiva de Buenas Prácticas de Manufactura para Laboratorios Farmacéuticos) is issued, published in Official Register No. 257, of 07 June 2018.
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.
Ecuador notified a revised version of this proposed TBT measure on 17 July 2026. The measure was first notified on 6 July 2022. The comment period closed on 15 September 2026.
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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.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
RevisionG/TBT/N/ECU/514/Rev.1
Comment deadline: Closed on 15 September 2026
Partial reform of Resolution ARCSA-DE-008-2018-JCGO through which the 'Substitute Sanitary Technical Regulation of Good Manufacturing Practices for Pharmaceutical Laboratories' (Normativa Técnica Sanitaria Sustitutiva de Buenas Prácticas de Manufactura para Laboratorios Farmacéuticos) is issued, published in Official Register No. 257, of 07 June 2018.
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.
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.
AddendumG/TBT/N/ECU/514/Add.2
Instructivo Externo IE-B.3.4.2-LF-02, versión 1, denominado 'Registro, renovación, modificación y cancelación voluntaria del Certificado de Buenas Prácticas de Manufactura (BPM) de laboratorios farmacéuticos extranjeros; y obtención, renovación, modificación y cancelación voluntaria de la Certificación de BPM emitida por la ARCSA a laboratorios farmacéuticos extranjeros' (External Instruction IE-B.3.4.2-LF-02, version 1, entitled 'Registration, renewal, modification and voluntary cancellation of
The Republic of Ecuador hereby notifies External Instruction IE-B.3.4.2-LF-02, version 1, entitled 'Registration, renewal, modification and voluntary cancellation of the certificate of good manufacturing practices (GMP) for foreign pharmaceutical laboratories; and the obtaining, renewal, modification and voluntary cancellation of the GMP certification issued by ARCSA for foreign pharmaceutical laboratories'.It should be noted that Ecuador has followed all the transparency and notification guidelines determined by the WTO. As such, on 6 July 2022, the draft partial amendment to the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories was notified in document G/TBT/N/ECU/514, with a period of 60 days for Member States to provide comments. On 5 January 2023, the partial amendment to the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories was notified in document G/TBT/N/ECU/514/Add.1.Ministerio de Producción, Comercio Exterior, Inversiones y Pesca, MPCEIP (Ministry of Production, Foreign Trade, Investment and Fisheries)Subsecretaría de Calidad (Under-Secretariat for Quality)Punto de Contacto OTC (TBT Enquiry Point)Primary enquiry point:Cristian Eduardo Yépez JaramilloPlataforma Gubernamental de Gestión FinancieraAv. Amazonas entre Unión Nacional de Periodistas y Alfonso PereiraPiso 8Bloque amarilloQuito EC170522Tel.: (+593 2) 3948760, Ext. 2254; Ext. 2252Email…
AddendumG/TBT/N/ECU/514/Add.1
REFORMA PARCIAL A LA NORMATIVA TÉCNICA SANITARIA SUSTITUTIVA DE BUENAS PRÁCTICAS DE MANUFACTURA PARA LABORATORIOS FARMACÉUTICOS (Partial amendment to the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories)
Partial amendment to the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories 1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final measure/change to the measure/interpretative guidance can be obtained. G/TBT/N/ECU/514/Add.1 - 2 - By means of this Addendum No. 1, the Republic of Ecuador advises that the Partial amendment to the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories has been issued pursuant to Resolution No. ARCSA-DE-2022-018-AKRG of 5 December 2022 by the National Agency for Sanitary Regulation, Control and Surveillance (ARCSA, Doctor Leopoldo Izquieta Pérez), in order to facilitate trade. The notified Sanitary Technical Regulations will enter into force six months after their signature, without prejudice to their publication in the Official Journal. Text available from: Ministerio de Producción, Comercio Exterior, Inversiones y Pesca (Ministry of Production, Foreign Trade, Investment and Fisheries), Subsecretaría de Calidad (Under-Secretariat for Quality), Organismo Nacional de Notificación (National Notification Authority) TBT enquiry point: Jeannette Mariño Plataforma Gubernamental de Gestión Financiera - Piso 8, Bloque amarillo, Av. Amazonas entre Unión Nacional de Periodistas y Alfonso Pereira Quito, Ecuador Tel.: (+593-2) 3948760, Ext. 2252/2254 Email…
Regular notificationG/TBT/N/ECU/514
Comment deadline: Closed on 4 September 2022
Proyecto de reforma parcial a la Normativa Técnica Sanitaria sustitutiva de Buenas Prácticas de Manufactura para laboratorios farmacéuticos (Draft partial amendment to the Substitute G/TBT/N/ECU/514 - 2 - Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories) (36 pages, in Spanish)
Draft partial amendment to the Substitute Sanitary Technical Regulations on good manufacturing practices for pharmaceutical laboratories, which seek to establish the requirements and guidelines for granting the certificate of good manufacturing practices to domestic and foreign pharmaceutical laboratories applying for sanitary registration in Ecuador that manufacture, process, package, store, distribute and transport medicines in general, medicines containing controlled substances, biological products, radiopharmaceuticals, active pharmaceutical ingredients and products undergoing research.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 25 December 2026.
Symbol: G/SPS/N/ECU/402Comments until 25 December 2026
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.
Symbol: G/SPS/N/ECU/401Comments until 13 November 2026
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.
No products listed by the notifying member
Symbol: G/SPS/N/ECU/400Comments until 13 November 2026
WTO notificationSPSProposed measure, open for commentsNew
Ecuador notified this proposed SPS measure to the WTO on 26 October 2026. Comments are open until 13 November 2026.
No products listed by the notifying member
Symbol: G/SPS/N/ECU/399Comments until 13 November 2026
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