Singapore Releases New Guidance on Minor Variation Applications for Drugs

In Singapore, medical companies that plan to make a change to one of their pharmaceutical products, such as a change in labeling, packaging or manufacturing site, may submit a minor variation (MIV) application to the Center for Drug Administration under the Health Sciences Authority (HSA). Conversely, in many other Asian countries, these types of product changes would require complete re-registration of the product. In January 2005, the HSA released updated guidance on minor variation applications for registered pharmaceuticals. This guidance divides minor variations into two categories: MIV-1 and MIV-2. Variations categorized as MIV-1 variations require regulatory approval; MIV-2 variations do not require HSA approval. The product license holder is responsible for submitting the MIV-1 or MIV-2 application and ensuring that all required documents are complete.

The following are some of the changes categorized as MIV-1 variations: (1) manufacturing site, (2) shelf-life, (3) storage conditions, (4) packager, (5) testing procedures, (6) pack size, and (7) product labeling. These changes will require that specific documents (usually 5-10 documents) be submitted to the HSA for approval, prior to the change.

MIV-2 variations require that a statement be submitted to the HSA only specifying the effective date of change, not requesting approval. This statement should be submitted at least two months prior to the implementation of the change and should be accompanied by supporting documents. MIV-2 variations include changes in the: (1) product owner, (2) manufacturer’s name or address, (3) name or address of the product license holder, (4) excipient, (5) composition of packaging material, (6) batch size, etc. Each minor variation must meet specific conditions in order to be categorized as an MIV-2 variation. If the conditions are not met, a MIV-1 application, requiring pre-approval, may be necessary.