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.
Highlights
Apart from these, Therapeutic Goods Administration (TGA) has described various categories of variation including Correction to an ARTG entry, notification, quality information containing self-assessable requests (SARs) and category 3 requests, product information related variation consists of minor editorial changes (MEC), Safety related requests (SRRs) and extension of indication to align with a reference product.[17,19]
From the current review work, it can be concluded that there is a vast difference in the post-approval changes requirement guidelines in Canada, Australia, and Saudi Arabia
A change in labelled storage condition and submission of transmissible spongiform encephalopathy (TSE) information are not mentioned in the guidelines given by regulatory authorities of Australia and Saudi Arabia
Summary
The guideline related to post-approval changes related to API are mainly described in the variation guidance document given for chemical entities.[16]. 2. Subsection 9D(2) permits ARTG entry changes related to the safety of the product as well as sequential changes into the finished pharmaceutical product. Subsection 9D(2C) allows changes to ARTG entry which does not affect safety, efficacy, and quality of medicine These kinds of changes require approval from TGA under certain conditions. Apart from these, TGA has described various categories of variation including Correction to an ARTG entry, notification, quality information containing self-assessable requests (SARs) and category 3 requests, product information related variation consists of minor editorial changes (MEC), Safety related requests (SRRs) and extension of indication to align with a reference product.[17,19]. For the description of various possible changes in the registered product, TGA has specified three different variation types:
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