The Therapeutic Products Branch (TPB) of the Health Science Authority (HSA) has announced the latest updates on regulatory procedures, as part of HSA’s initiative to enhance regulatory efficiency. The updated guidance below is effective from 1 August 2024:
i) Application Timeline Calculator
A new webtool was developed to assist the industry in estimating its key evaluation milestone involving the New Drug Application (NDA), General Drug Application (GDA), and Major Variation-1 Application (MAV-1) full and abridges applications to receive its first evaluation Input Request (IR).
These milestone dates are calculated based on working days (WD) and the application turnaround times not including the screening process. However, the dates provided from the calculation are only an estimation to facilitate the submission planning and management.
ii) EasiShare
A new cloud-based file exchange software is provided for companies as an alternative option to submit their application dossiers apart submission via electronic media or PRISM.
Application submission via EasiShare has 4 requirements as stated in the guidance (Key Points to Note when Preparing Documents for Therapeutic Application Dossier Submission via EasiShare):
1. One File Upload Request URL per company
2. Use zipped file format for both application dossier and DMF submission
3. Max zipped file size is 450Mb
4. Check before refreshing
HSA strictly reminded companies to adhere to the requirements outlined in points 2 and 3 to ensure HSA can receive, identify, and retrieve your submitted documents to match with the PRISM/DMF application.
iii) Guideline for Post-Approval Changes that Do Not Require Notification to HSA
11 post-approval changes have been updated from acquiring notification to HS which are:
Product Labels, Raw Materials, Starting Materials, Excipients, Packaging Materials of a Drug Substance, Packaging Materials of a Drug Product, Reference Standards, Post-Approval Stability Protocol for a Drug Substance, Post-Approval Stability Protocol for a Drug Product, Change of Production Activities Within the Same Manufacturing Site, and Medical Device Supplied with Therapeutic Products
iv) Health Products (Therapeutic Products) (Amendment) Regulation 2024
The patent declaration forms specified under Regulations 23(2) and 23(5) of the Therapeutic Products Regulation 2016 and Regulation 23(8)(b)(ii) of the Amended Regulation 2024 have been updated and should be used effectively from 1 August 2024.
The amended regulation was made based on industry feedback on the detailed scope of patents and patent declaration under the revised regulation 23.
v) Swissmedics Added to the List of HSA’s Reference Agencies
HSA now recognized 6 reference agencies including Swissmedics as the latest addition to the list. (FDA, EMA, Health Canada, MHRA, TGA, and Swissmedics)
Meanwhile, the implementation of Good Manufacturing Practices (GMP) requirements for chemical drug substance (DS) manufacturers will take effect on 1 October 2024. After 1-year transitional period, companies that submit NDAs, GDAs, and MIV-1 applications (for additional new chemical DS manufacturers) on or after the effective date, are required to be accompanied by the GMP Compliance Evidence for DS Manufacturers.
Source: Health Science Authority (HSA)
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