Background: In this era of evolution, quality and safety of
pharmaceutical dosage forms have been given a prime importance. In this context,
a detailed knowledge about physical and chemical properties of excipients is not
sufficient, but information about safety and regulatory status of these materials is
now essential to know. The present work will be beneficial to focus more on the
safety, quality and stability of pharmaceutical product.
Objective: Study of regulatory mechanism for pharmaceutical excipients in US,
Europe and Japan.
Method: As an initial step, information about the history and general regulatory
perspectives of each country was gathered and referred. After that the different regulatory
mechanisms for pharmaceutical excipients in regulated market were understood from data obtained
from the above sources and conclusion was made from that.
Results & Conclusion: Excipients are crucial element of pharmaceutical dosage form so they should
be regulated to minimize risk. This article presents a current regulatory mechanism for
pharmaceutical excipients in regulated market like US, Europe and Japan. According to the
regulative point of view, concern relating to the excipients involves Good Manufacturing Practices,
Toxicity, Safety, Quality Assurance, Stability, Labeling and Approval regulations. This article also
overviews the guidance documents published by the IPEC for regulating excipients which is helpful
to harmonize regulatory standards of excipients & enhance development of excipients with introduction
of novel excipients.