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Healthcare & Life Sciences

March 07 2018
Brandon Heard New guidance document on administrative processing of drug submissions and applications

Canada - Smart & Biggar/Fetherstonhaugh

Health Canada recently announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, for manufacturer and product name change applications, additional product name applications and licensing agreements between two manufacturers. The guidance will be effective from March 1 2018.

Author: Brandon Heard
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Andrew Mandlsohn Consultation on use of foreign-sourced reference product as Canadian reference product

Canada - Smart & Biggar/Fetherstonhaugh

Health Canada recently published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its guidance document on the use of a foreign-sourced reference product as a Canadian reference product. Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.

Author: Andrew Mandlsohn
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Recent updates

E Sevi Fırat Pharmaceutical market access in Turkey – a regulatory roadmap

Turkey - Fırat Izgi Attorney Partnership

Author: E Sevi Fırat
Rainer Herzig Medical confidentiality and right to refuse to give evidence

Austria - Preslmayr Attorneys at Law

Author: Rainer Herzig
Abigail Smith Apotex granted damages for delayed FDA approval of two products

Canada - Smart & Biggar/Fetherstonhaugh

Author: Abigail Smith
Costanza Mariconda New legislation surrounding medical malpractice

Italy - Mariconda e Associati Studio Legale

Author: Costanza Mariconda
Altair Richards Medical products: incentives regulation reloaded

South Africa - ENSafrica

Author: Altair Richards
Scott D Stein Court corrects ruling requiring laboratories to verify medical necessity independently

USA - Sidley Austin LLP

Authors: Scott D Stein, Brenna E Jenny