WTO notification · TBT
ChileUpdated: check whether it is now adopted or in force
Draft update to Technical Standard (Norma Técnica) No. 170 on the sanitary registration of biosimilar biotechnological products
Propuesta de actualización Norma Técnica N°170 sobre el registro sanitario de productos biotecnológicos biosimilares
Chile issued an addendum on 6 March 2026 to the earlier TBT notification G/TBT/N/CHL/786. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 12 February 2026. The comment period closed on 13 April 2026.
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biosimilar biotechnological products (Productos biotecnológicos biosimilares)
Productos biotecnológicos biosimilares
The comment period closed on 13 April 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CHL/786/Add.1; it can take them up with Chile.
Find your country's enquiry point on WTO ePing (opens in a new tab)Latest notice (G/TBT/N/CHL/786/Add.1, 6 March 2026)
Proposed update to Technical Standard No. 170 on the registration of biosimilar biotechnology products
The Republic of Chile hereby advises that the comment period for the proposed update to Ministry of Health Technical Standard No. 170 on the registration of biosimilar biotechnology products, notified by the World Trade Organization on 12 February 2026, has been extended until 13 April 2026.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.
The notified technical standard will be used in the registration process for biosimilar biotechnology medicines, to specify the provisions of MINSAL Supreme Decree No. 3/10 and establish the requirements to be met when submitting the health registration referred to in Article 42 (i).The purpose of this standard, which complements the regulations in force, is to provide internationally accepted requirements for the authorization of biosimilar products, that is, those declared to be similar to original biological products, which were authorized based on a complete quality, safety and efficacy dossier.This standard does not apply to vaccines, blood products, heparins or advanced therapies. These types of products have their own particularities, and there are national and international regulations that set out the registration requirements for these types of medicines.
Every notice about this measure published here, newest first. Each one is the notifying member's own text.
AddendumG/TBT/N/CHL/786/Add.1
Comment deadline: Closed on 13 April 2026
Proposed update to Technical Standard No. 170 on the registration of biosimilar biotechnology products
The Republic of Chile hereby advises that the comment period for the proposed update to Ministry of Health Technical Standard No. 170 on the registration of biosimilar biotechnology products, notified by the World Trade Organization on 12 February 2026, has been extended until 13 April 2026.__________1 This information can be provided by including a website address, a PDF attachment, or other information on where the text of the final/modified measure and/or interpretative guidance can be obtained.
Regular notificationG/TBT/N/CHL/786
Comment deadline: Closed on 14 March 2026
Draft update to Technical Standard (Norma Técnica) No. 170 on the sanitary registration of biosimilar biotechnological products
Propuesta de actualización Norma Técnica N°170 sobre el registro sanitario de productos biotecnológicos biosimilares
The notified technical standard will be used in the registration process for biosimilar biotechnology medicines, to specify the provisions of MINSAL Supreme Decree No. 3/10 and establish the requirements to be met when submitting the health registration referred to in Article 42 (i).The purpose of this standard, which complements the regulations in force, is to provide internationally accepted requirements for the authorization of biosimilar products, that is, those declared to be similar to original biological products, which were authorized based on a complete quality, safety and efficacy dossier.This standard does not apply to vaccines, blood products, heparins or advanced therapies. These types of products have their own particularities, and there are national and international regulations that set out the registration requirements for these types of medicines.
Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.
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Symbol: G/SPS/N/CHL/899Comments until 5 January 2027
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Symbol: G/SPS/N/CHL/897/Add.1
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Symbol: G/TBT/N/CHL/586/Add.2Comment period closed
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Chile notified this proposed TBT measure to the WTO on 21 October 2026. Comments are open until 20 December 2026.
Symbol: G/TBT/N/CHL/807Comments until 20 December 2026
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