Overview of Post Approval Changes Requirements for Active Pharmaceutical Ingredients in Canada, Australia and Saudi Arabia

Abstract

Regardless of a product’s country of registration, a current and updated pharmaceutical product dossier is mandatory. But any kind of post-approval change to pharmaceutical products requires prior permission or at least notification to the regulatory authorities of the country. The reason behind the post approval changes may vary including product quality advancement, reduction of cost or improvement of the appearance of a product label, etc. As it is compulsory to provide the details of post-approval changes made in pharmaceutical products, thorough knowledge of guidance documents of concerned regulatory authority is vital. Therefore, understanding a need for post-approval changes together with avoiding any unnecessary changes is an integral part of the medicinal product’s lifecycle management. Not only the changes of finished pharmaceutical products, but regulatory authorities also concern about the necessity of changes of active pharmaceutical ingredients, as these changes may impact on finished product’s quality. The present article focuses on a comprehensive review of the requirements of post-approval changes related to active pharmaceutical ingredients for Canada, Australia, and Saudi Arabia, which may help pharmaceutical industries to comply with the requirements simultaneously in the proposed countries.

Keywords: Variation; Changes in Registered Product; API; Drug Substance; Regulated Market; Emerging Market; GCC Country