The Regulations Of Generic Drugs
The Regulations of Generic Drugs
The way of approving a generic drug was made easier by the Drug Price and Patent Term Restoration Act of 1984 that was introduced and more well known as Hatch-Watchman Act named from its main sponsors.
The FDA otherwise known as the Food and Drug Administration approves generic drugs just like all types of drugs in the United States.
The Inventor Drugs under went a long clinical testing time to make sure that everything was safe so that they could do the claim.
All Generic Drugs are tested differently. They go through a clinical trial and the information will already exist for the original drug. All generic versions have to prove that they are safe and have good ingredients in them that work just like the original drugs do.
Bioequivalence is stated by the FDA to be the absence of a big difference in the rate and extent to how the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives are available at the place of the drug action when it is given at the same molar dose under the conditions in an appropriate study.
This actually means that it releases the same amount of the same active ingredient over the same scale as the original drug.
After an existing patent has ran out the applicant can then submit an ANDA or Abbreviated New Drug Application and bioequivalence tests are carried out. Once approved the new Drugs is added to the Approved Drug Products List along with its bio equivalence standards.