Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications".
A summary of the current situation is provided in this guidance on how to submit regulatory information to Swissmedic in eCTD format.
By describing the electronic format requirements for drug submissions submitted in accordance with the Therapeutic Product Act (TPA) and all related ordinances, the eCTD format will be integrated into the Swissmedic registration framework.
This guidance applies to pharmaceuticals, biologicals and vaccines, blood and blood derivatives as well as products pertaining to complementary medicines for human use. The eCTD format is also encouraged for the drug component of drug and device combinations, where the primary mechanism of action is drug-related.
Swissmedic accepts media such as CD-ROMs, DVD-ROMs and Blu-Ray discs. Any other hardware such as laptops, desktops, hard drives, USB sticks etc. will not be accepted. The electronic information should be directly readable and usable on Swissmedic’s hardware. For very large submissions, Swissmedic prefers using a single disk to multiple smaller ones. Modules must not be split over multiple disks.
For more details on Life cycle management and responses to the List of Questions, associated with swissmedic eCTD, click this LINK.
This guidance describes the timetable for authorisation procedures and defines the time limits observed by Swissmedic in connection with submitted authorisation applications and focuses on three primary objectives:
Make all parties aware of the time limits to be respected by Swissmedic and by the applicant.
Explain the procedure to be followed for applications that are incomplete in terms of formal requirements and content.
By specifying procedure periods, help the applicant with its planning and enable key data to be recorded on the duration of procedures overall and on individual procedure sections
The total processing time for an authorisation procedure (procedure period) is calculated as the sum of the total of Swissmedic and applicant times.
Click this LINK to know more about this guidance & to know about the complete list of procedure periods.
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