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Atualizações regulatórias

Mudanças dos órgãos reguladores da Índia e dos países de destino que afetam a forma como os medicamentos são exportados, documentados, pagos e importados, cada uma com sua fonte e o que significa para os compradores.

10 atualizações

Resposta curta

Cada atualização registra uma mudança datada, como um aviso aduaneiro, uma regra de pagamento ou um novo procedimento de importação, com a fonte primária, quem é afetado e o que os compradores devem fazer agora. As minutas são identificadas como minutas até se tornarem lei.

outubro de 2026

  1. 25 de outubro de 2026Rotas de acesso

    Saudi SFDA updates its SAP guideline for unregistered medicines

    The Saudi Food and Drug Authority has published version 2.0 of its Special Access Program guideline, dated 25 October 2026. It adds a route for rare disease medicines, splits approval from the import licence request, and sets a 7 working day decision target. The medicine must be approved by one of seven reference regulators or under registration with SFDA.

    Leia a atualização
  2. 12 de outubro de 2026Regras de exportação da Índia

    CDSCO says approved r-DNA products need no separate export NOC for an export brand

    A CDSCO notice of October 2026 clarifies that an r-DNA drug already holding an Indian marketing authorisation in Form CT-23 needs no separate CDSCO export NOC when the only change is a brand name used for export. Any other change keeps the quantity-specific export NOC, which matters for buyers of Indian recombinant biologics.

    Leia a atualização

outubro de 2026

  1. 1 de outubro de 2026Pagamentos e preçosDocumentos

    India's FEMA 2026 export rules take effect with a nine-month realisation period

    India's new Foreign Exchange Management (Export and Import of Goods and Services) Regulations 2026 took effect on 1 October 2026. An RBI amendment of 22 September 2026 cut the period for Indian exporters to receive payment from 15 months to 9 months after shipment, or 12 months for rupee invoices, which shapes payment terms offered to overseas buyers.

    Leia a atualização
  2. 1 de outubro de 2026Regras de exportação da ÍndiaDocumentos

    Nhava Sheva extends post facto export NOC relaxation to 31 December 2026

    Jawaharlal Nehru Custom House has extended to 31 December 2026 the interim relaxation that lets unapproved, new or banned drugs made for export clear with a CDSCO NOC obtained after manufacture. From 1 January 2027 these exports must fully follow the CDSCO Office Order of 30 April 2024, which affects lead times for products not approved in India.

    Leia a atualização
  3. 28 de setembro de 2026Regras de exportação da Índia

    India's draft Rule 65(22) would curb prescription drug advertising by drug sellers

    A draft amendment to India's Drugs Rules, G.S.R. 861(E) of 28 September 2026, would bar retail and wholesale drug licence holders, including online pharmacies and distributors, from advertising Schedule H, H1 or X medicines without prior Central Government sanction. It is a draft open for comment, not yet law, and would shape how Indian suppliers present prescription medicines online.

    Leia a atualização

abril de 2026

  1. 28 de abril de 2026Ensaios clínicos

    New UK clinical trials regulations take effect on 28 April 2026

    The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 came into force in the UK on 28 April 2026. They speed up combined MHRA and ethics review, add a notification route for lower-risk trials and make trial registration and results publication legal duties. Sponsors and CROs sourcing comparators from India should expect shorter start-up windows.

    Leia a atualização
  2. 12 de abril de 2026Qualidade e segurançaTransporte e cadeia fria

    Qatar requires two thirds of shelf life left on imported medicines

    Qatar's Ministry of Public Health issued a circular, reported on 12 April 2026, requiring imported medicines to arrive with at least two thirds of their shelf life remaining. It took immediate effect for licensed agents and importers. Products that fall short need an exemption from the Department of Pharmacy and Drug Control, which matters for short-dated specialty and orphan batches.

    Leia a atualização

dezembro de 2025

  1. 15 de dezembro de 2025Rotas de acesso

    Russia extends the foreign packaging regime for registered medicines to 2027

    Russia's Federal Law 483-FZ of 15 December 2025 extends to 31 December 2027 the regime that lets registered medicines in packaging made for other markets be imported and sold when there is a shortage, or a risk of one, linked to sanctions. It helps manufacturers already registered in Russia but does not open a route for unregistered medicines.

    Leia a atualização

julho de 2025

  1. 17 de julho de 2025Regras de exportação da ÍndiaQualidade e segurança

    CDSCO export NOC guidance brings one-year NOCs and a 60 percent shelf-life rule

    CDSCO's revised export NOC guidance of 17 July 2025 replaces per-order NOCs for unapproved and approved new drugs made in India for export with a one-year NOC issued after a one-time registration. Unexported formulation stock can be reused only with 60 percent of shelf life left, and banned and NDPS drugs still need per-order NOCs.

    Leia a atualização

julho de 2025

  1. 1 de julho de 2025Rotas de acessoQualidade e segurança

    Vietnam's Decree 163/2025 replaces Decree 54/2017 for drug imports

    Vietnam's Decree 163/2025/ND-CP took effect on 1 July 2025 with the amended Law on Pharmacy, replacing Decree 54/2017. It restates when a drug without a Vietnamese marketing authorisation can be licensed for import, sets 15 days for special treatment needs licences, and adds shelf-life and advance notice rules that overseas suppliers need to plan for.

    Leia a atualização

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