The committee's advice was sought on 7 applications under evaluation by the TGA. The applications included:
one for the registration of a new chemical entity
one for the registration of a new biological entity
three seeking extension of indications
one seeking a major variation to add a new dosing regimen
one seeking a minor variation to amend the specifications
Members
Membership comprises of professionals with specific scientific, medical or clinical expertise, as well as appropriate consumer health issues relating to medicines.