The Health Sciences Authority (HSA) Singapore has provided a list of the latest regulatory updates for therapeutic product registration in April 2022.
The changes include revised checklists for post-approval minor variations, namely MIV-1 and MIV-2. These changes include re-categorisation of variation categories (for drug substance, drug product and excipients), inclusion of new checklists and others.
The verification evaluation route can now be used to register biological products, including biosimilar products. You may check the eligibility for the route in Sections 14.3 and 24.1 in the main guidance.
There are also other minor updates, and these are listed in the HSA website.
More details can be found in “Regulatory Updates for Therapeutic Product Registration, April 2022”: https://www.hsa.gov.sg/announcements/regulatory-updates/regulatory-updates-for-therapeutic-product-registration