19 February, 2019
The Health Sciences Authority ("HSA") has revised the Guidance on Therapeutic Product Registration in Singapore (the "Guidance"). The revised Guidance was published on 15 January 2019 and came into force on the same date. The key changes are as follows:
1. Site-specific stability data requirement streamlined
Changes have been made to the requirements for registration of multiple primary packagers of therapeutic products. Primary packagers refer to primary packaging sites in which therapeutic products are packaged after manufacture.
Prior to the revision, in order to register multiple primary packagers, companies had to include in their dataset a minimum of one set of 12 months stability data from one of the primary packaging sites, transport validation of the bulk product to the other proposed primary packaging site(s), and a minimum of one set of 6 months of stability data from the other primary packaging site(s) with a commitment to provide the data upon completion of the stability study.
The stability data requirement has now been streamlined to remove the need for any site-specific data. Applicants would only have to submit transport validation of the bulk product. However, this only applies if the same container closure system is used for all sites, and to new drug applications, generic drug applications and post-approval variations.
This change further aligns the stability data requirements with that of chemical and biological therapeutic products.
2. Guidelines on Minor Variation Applications for Chemical Therapeutic Products Revised
Changes have been made to Appendix 13 of the Guidance, which contains guidelines on minor variation applications ("MIV") for chemical therapeutic products. Some of the key changes highlighted by the HSA are as follows:
- An addition or replacement of an alternative site for primary packaging for a non-sterile product may be submitted as a MIV-2 application.
- A new checklist for “Change of Specification of Drug Product” has been added. This change was previously included under “Change of Specification of Drug Substance (where CEP is not available)”.
- A MIV-1 submission will be required for the deletion of a specification parameter which may have a significant effect on the quality of the drug substance or drug product.
- No variation application will be required for changes in the supplier of the primary packaging material, provided that the type of primary packaging material and specification remain unchanged.
- Two MIV-2 checklists have been added, namely, the “Submission of CEP for an approved drug substance manufacturer” and the “Change of Specification of starting material”.
- Any “Change in Name and/or address of Product Registrant” should be submitted via Transfer@PRISM instead.
Other changes have also been made to streamline submission requirements (e.g. checklists B8, C6, C12, C16, C22), enhance certain checklists (e.g. checklist B5, B7, B15, C27), and clarify conditions and/or documentation requirements.
3. Creation of e-forms for Patent Declaration Forms and Drug Master File ("DMF") Submission Forms
The HSA has also converted the existing Word document format of Patent Declaration Forms and DMF Submission Forms into an electronic PDF format. With the digitised forms, applicants will no longer have to print, sign and scan the hardcopy forms.
More information about the changes can be found here and the revised Guidance can be found here.
For further information, please contact:
Andy Leck, Principal, Baker & McKenzie.Wong & Leow
andy.leck@bakermckenzie.com
