To: All Product Licence Holder
Revision of Drug Registration Guidelines on Minor Variation Applications (effective 1 February 2005)
The Centre for Drug Administration (CDA), HSA conducts regular reviews of its regulatory processes and requirements to enhance the robustness, transparency and clarity of its regulatory systems. In tandem with this initiative, CDA conducted a review of the minor variation guidelines. Feedback received by CDA was considered in the revision.
The revised DR Guidelines On Minor Variation Applications are available for downloading at the following link:
We seek your cooperation in familiarising yourselves with the revised guidance document. Should you require further clarification or wish to provide feedback or comments, please e-mail your enquiry or comments to: HSA_Drug_Registration@hsa.gov.sg.
