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Singapore Making ‘Key Changes’ Ahead Of eCTD Implementation

 
• By Neena Brizmohun

Submission order, identifiers and electronic signatures in pdfs are among the issues that the Health Sciences Authority is addressing as it prepares to implement the electronic common technical document format for dossier submissions this year.

Dossier submission via eCTD allows for better product life cycle management • Source: Shutterstock

Singapore’s Health Sciences Authority has provided an update on its planned implementation of the electronic common technical document (eCTD) format for dossier submissions and the key changes it is making following a consultation on the plan that received over 250 comments from 25 companies.

Companies using the eCTD format, which the HSA expects to introduce in Q4 2024, will no longer be prohibited from using electronic signatures on PDF

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 
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Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

Industry On Making England’s HTA Innovation Lab A Success

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.