{"id":27697,"date":"2026-10-30T12:42:20","date_gmt":"2026-10-30T10:42:20","guid":{"rendered":"https:\/\/makingpharmaindustry.it\/non-categorizzato\/principi-attivi-da-singapore-cosa-cambia-per-lue\/"},"modified":"2026-11-02T13:36:34","modified_gmt":"2026-11-02T11:36:34","slug":"principi-attivi-da-singapore-cosa-cambia-per-lue","status":"publish","type":"post","link":"https:\/\/makingpharmaindustry.it\/en\/regulatory\/legislation\/principi-attivi-da-singapore-cosa-cambia-per-lue\/","title":{"rendered":"Active pharmaceutical ingredients from Singapore: what changes for the EU?"},"content":{"rendered":"

The importation of active pharmaceutical ingredients (APIs)<\/strong> from Singapore into the European Union is set to undergo a specific change in documentation requirements. With Singapore\u2019s inclusion on the EU list of third countries with regulatory frameworks recognised as equivalent, the written confirmation requirement applicable to APIs imported from countries not included on the list will no longer apply.<\/p>\n

This development concerns how the EU recognises the regulatory oversight exercised by the competent authority in the country of manufacture. For pharmaceutical companies, it represents a simplification to be incorporated into their supply chain management processes, while maintaining a clear distinction between recognition of a national regulatory system and qualification of an individual supplier.<\/p>\n

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Recognition and key dates<\/h2>\n

Commission Implementing Decision (EU) 2026\/2347<\/strong> amends the Annex to Decision 2012\/715\/EU, adding Singapore to the list of third countries whose regulatory frameworks and oversight activities for APIs ensure a level of public health protection equivalent to that provided in the European Union.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

Commission Implementing Decision (EU) 2026\/2347<\/span><\/a><\/p>\n

The act is dated 23 October 2026, was published in the Official Journal of the European Union on 26 October 2026, and enters into force on the twentieth day following its publication, namely 15 November 2026.<\/p>\n

The European Commission announced the recognition on 28 October. The assessment process began with Singapore\u2019s application in February 2025 and included a review of documentation provided by the Health Sciences Authority (HSA), as well as an on-site assessment of the country’s regulatory system. The evaluation therefore also covered the authority\u2019s ability to exercise regulatory oversight and enforce compliance.<\/p>\n

For companies managing API imports, the relevant date to reflect in their procedures is the entry into force of the act. The publication of an official announcement and the date on which the measure becomes applicable are two distinct steps.<\/p>\n

The purpose of written confirmation<\/h2>\n

The EU regulatory framework governing the importation of active pharmaceutical ingredients for medicinal products for human use was strengthened by Directive 2011\/62\/EU<\/a>, which amended Directive 2001\/83\/EC. Article 46b requires imported APIs to be manufactured in accordance with GMP standards at least equivalent to those applicable in the EU and, unless an exemption applies, to be accompanied by written confirmation issued by the competent authority of the third country.<\/p>\n

The written confirmation certifies that the manufacturing site is subject to equivalent GMP standards and to regular, strict and transparent inspections, with effective enforcement of GMP requirements. Inclusion of a country on the list established under Article 111b allows an exemption from this documentation requirement.<\/p>\n

The European Commission\u2019s Q&A also clarify that written confirmation is issued for the manufacturing site and the active substances manufactured there, rather than separately for each batch. Each shipment subject to the requirement must be accompanied by the relevant document. A copy is acceptable provided that the original written confirmation remains valid.<\/p>\n

Country recognition and supplier qualification<\/h2>\n

The requirement to use active pharmaceutical ingredients manufactured in accordance with GMP remains in force. Recognition allows reliance on the national regulatory oversight system for the specific importation mechanism, while maintaining visibility and understanding of the supply chain remains an essential responsibility for pharmaceutical companies.<\/p>\n

Chapter 5 of the EU GMP guidelines requires the selection, qualification, approval and ongoing monitoring of starting material suppliers to be documented within the pharmaceutical quality system. For APIs, it requires audits of manufacturers and distributors, together with a risk-based assessment of the supply chain.<\/p>\n

In practice, country recognition and supplier approval address different questions. The former concerns the competent authority\u2019s ability to oversee manufacturing activities. The latter focuses on the specific relationship between a manufacturing site, a material and its intended use in a medicinal product.<\/p>\n

A supplier may operate in a recognised country and still require further assessment of its manufacturing processes, change management practices or ability to ensure continuity of supply. These aspects must be evaluated in the context of the specific supply arrangement, taking into account the available evidence.<\/p>\n

Where the active pharmaceutical ingredient is manufactured matters<\/h2>\n

A particularly important consideration concerns supply chains involving intermediaries or multiple countries. The European Commission\u2019s Q&A clarify that if an API is manufactured in Country A and imported into the EU through Country B, the written confirmation must be issued by the country where manufacturing takes place.<\/p>\n

Simply routing an API through Singapore for commercial or logistical purposes is therefore not sufficient to benefit from the new recognition. Determining the applicable requirements involves identifying the manufacturing site and tracing the operations performed along the supply chain.<\/p>\n

Consider, for example, a company based in Singapore that markets an API manufactured elsewhere. The seller\u2019s registered office, the shipping location and the manufacturing site represent three different pieces of information. Confusing them could lead to inappropriate changes to the documentation required upon receipt.<\/p>\n

This illustrates how supply chain traceability also affects the interpretation of regulatory simplifications. Commercial supplier records must be aligned with technical information and the documentation used by the quality function.<\/p>\n

A measure specifically concerning APIs<\/h2>\n

The scope of the decision is limited to active pharmaceutical ingredients intended for medicinal products for human use. Recognition does not constitute a marketing authorisation for medicinal products, nor does it provide a general exemption from import controls applicable to finished medicinal products.<\/p>\n

The European Commission\u2019s Q&A explicitly distinguish between the importation of APIs and that of finished medicinal products. They also clarify that the written confirmation mechanism operates independently of the existence of Mutual Recognition Agreements (MRAs).<\/p>\n

The development should therefore be described as recognition of the equivalence of the regulatory oversight system for APIs, without extending its effects to other activities or products.<\/p>\n

Translating the regulatory change into company procedures<\/h2>\n

A useful starting point is to identify APIs actually manufactured in Singapore, distinguishing them from those purchased through companies based in the country. This mapping can then be used to identify procedures and checklists that refer to the written confirmation requirement.<\/p>\n

Any updates should clearly specify the legal basis, effective date and scope of the exemption. It is also advisable to verify that information systems and goods receipt instructions do not continue to automatically require documentation that is no longer necessary for the supplies concerned.<\/p>\n

At the same time, the review should preserve the distinction between regulatory import documentation and the evidence used for supplier qualification. This allows the simplification to be implemented without creating uncertainty about which controls have been updated and why.<\/p>\n

Diversification also depends on industrial capabilities<\/h2>\n

From an industrial perspective, recognition may remove an administrative barrier to sourcing APIs from suppliers located in Singapore. However, the decision alone does not demonstrate that manufacturing capacity is available for a particular API or that a new source can already be incorporated into a customer\u2019s manufacturing process.<\/p>\n

The feasibility of supply chain diversification must be assessed by considering material availability, quality attributes, qualification timelines, regulatory implications and upstream dependencies. Even two manufacturers operating in different geographical locations may rely on the same intermediate or critical raw material.<\/p>\n

The value of this development therefore lies in the opportunity to establish supply relationships with one fewer documentation requirement, within a recognised regulatory oversight framework. For pharmaceutical companies, sourcing decisions remain dependent on a thorough understanding of the product and its supply chain: where the API is manufactured, which suppliers and resources that production depends on, and what evidence supports its reliability.<\/p>\n","protected":false},"excerpt":{"rendered":"

The EU recognises the equivalence of Singapore\u2019s regulatory oversight system for APIs. Its inclusion on the list of recognised countries simplifies import documentation requirements, while GMP compliance and supplier qualification obligations remain in place.<\/p>\n","protected":false},"author":32,"featured_media":27691,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1101,822,796],"tags":[],"class_list":["post-27697","post","type-post","status-publish","format-standard","has-post-thumbnail","category-highlights-en","category-legislation","category-market"],"yoast_head":"\nActive pharmaceutical ingredients from Singapore<\/title>\n<meta name=\"description\" content=\"Il riconoscimento di Singapore semplifica l\u2019importazione di principi attivi nell\u2019UE. 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