Thailand to Amend Bioequivalence Requirement for New Generic Drugs

In August 2011, the Thai FDA announced plans to amend the requirement regulating bioequivalence studies of new generic drugs. This change is made in an effort to expedite the drug approval process and provide more patients access to generic drugs in Thailand in the near future.

Once in effect, this amendment will allow pharmaceutical companies that want to register new generic drugs to submit bioequivalence study results from foreign institutes or laboratories. Previously, foreign bioequivalence studies were not accepted by the Thai FDA as part of the drug registration process. Drug companies must submit the dossiers within 120 days after the foreign bioequivalence study is completed. The Thai FDA will limit registration applications to no more than one new generic drug at a time per company. The applying pharmaceutical companies need to supply all documents and necessary information for the drug registration in a timely manner. In addition, pharmaceutical companies can apply for a second application for a different generic drug no more than 90 days after their first application.

Bioequivalence tests are conducted to assure therapeutic equivalence of generic products to innovator products.