Introduction: The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal includes two exemptions from IND... Read more
There are several monograph categories for Over-the-Counter (OTC) Drugs in Canada. These include Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (i.e. NSAIDs).
Any company (domestic or international) that manufactures, distributes, or imports OTC pharmaceuticals must provide proof that they adhere to GMP.
A mandatory requirement to fabricate (manufacture), package, label, test, import, distribute, or wholesale a finished drug or bulk process intermediate drug.