During the week of October 28th, the Global Index powered by Hoodin recognised 126 regulatory news and updates related to medical devices, IVD, SaMD, pharmaceuticals and biotech (and combination products). Check out what the Hoodin system recognised as the top picks* below, where they are presented as summarised versions together with an analysis of the potential implications. From last week there are important updates and news by MHRA (UK) and FDA (US) in this issue of Global Reg Top Picks by Hoodin.
Global Reg Index by Hoodin
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Top Picks for October 28 - November 3
Medicines eligible for Northern Ireland MHRA Authorised Route MHRA (UK) | Published Nov 1
EUROPE | PHARMACEUTICAL | BIOTECH
SUMMARY The MHRA Guidance on Medicines Eligible for Northern Ireland Authorised Route sets out the categories of medicines that can be moved to Northern Ireland under MHRA regulation to meet patient needs. This guidance aims to streamline regulatory requirements for pharmaceutical products travelling from Great Britain to Northern Ireland, addressing challenges posed by the Northern Ireland Protocol.
IMPLICATIONS Regulatory Compliance: Pharmaceutical and biotech companies must adhere to specific MHRA guidelines for transporting medicines to Northern Ireland, distinct from EU or GB rules.
Supply Chain Adjustments: Companies may need to revise distribution plans to comply with the authorised route requirements, impacting logistics, warehousing, and timelines.
Market Access: This guidance ensures continued patient access to essential medicines in Northern Ireland, which may affect market strategy for companies with UK and EU operations.
Risk of Disruption: Non-compliance could lead to supply disruptions in Northern Ireland, necessitating careful planning and alignment with MHRA-authorised processes.
This guidance serves as a crucial update for pharmaceutical and biotech firms with Northern Ireland as a target market, enabling them to maintain compliance while ensuring uninterrupted patient care.
Updated Generic Submissions Under Review List (Expanded) | Health Canada (Canada) | Published Nov 2 NORTH AMERICA | PHARMACEUTICALS | BIOTECH
SUMMARY Health Canada has released an updated Generic Submissions Under Review List, which includes details on medicinal ingredients and therapeutic areas of generic drug applications currently in the review process. This expanded list provides essential data for stakeholders on pending generic approvals in the Canadian market.
IMPLICATIONS
Therapeutic Scope: The diverse therapeutic categories covered by the list necessitate a strategic approach to product development, ensuring that submissions align with existing market needs and therapeutic equivalence standards.
Market Intelligence: Understanding the submissions can provide valuable insights into current trends in generic drug approvals and help identify potential opportunities for new product development.
Compliance Strategy: RAQA teams must ensure that generic products are rigorously developed to meet regulatory requirements for therapeutic equivalence, facilitating smoother market entry and compliance.tices, making it easier for stakeholders to comply with evolving regulatory frameworks.
* Top picks may not be the biggest news, as those updates might have already reached you. Instead, the top picks highlight the most important developments for key players in the life sciences industry that you may have missed during the week.
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