Post-Approval Change Process on Stage

Published on: 

The Post-Approval Changes Keynote Series on the Innovation Stage at INTERPHEX today will feature experts in the current industry efforts to address the challenges of post-approval changes. This article reports some of the recent industry activities seeking solutions to this issue.

The current cost and complexity of implementing post-approval changes to a manufacturing process is discouraging companies from updating facilities and systems, but modernization is crucial for improving quality and preventing drug shortages. “Even when changes are needed to keep a facility or process running efficiently, each global process change implementation takes four to five years. This has an impact on motivation, and when there is no motivation for change, facilities age and become prone to breakdowns. In some cases, the result is drug shortages,” Maik Jornitz, a member of the Parenteral Drug Association (PDA)’s Innovation for Availability of Medicines (PAC iAM) Task Force, told Pharmaceutical Technology in an interview.

PDA announced the formation of a Post Approval Changes: Innovation for Availability of Medicines (PAC iAM) Program in August, 2016 to address this concern. In Dec. 2016, PDA launched a survey of the industry, and the group plans to discuss preliminary results in April at the 2017 PDA Annual Meeting.

The DME Facility Focus survey also found that the majority of respondents were concerned about regulatory challenges as they sought to adopt new technologies for facility modernization, reported David M. Marks, president of DME, in an article for Pharmaceutical Technology. DME’s survey suggested a proactive-rather than a reactive-approach as a  best practice for implementing facility updates. 


An International Council for Harmonization (ICH) expert working group seeks to better manage post-approval changes through a proposed ICH Q12 program on product lifecycle management, reported Jill Wechsler in a Sept. 2, 2016 Pharmaceutical Technology article. Clarifying which changes are “established conditions” and how these can be managed is key.

In today’s session at INTERPHEX on the Innovation Stage, Maik Jornitz will examine ongoing challenges with implementing post-approval changes and discuss findings of PDA task force activities. In addition, Kashappa Goud Desai, PhD, Biopharmaceutical Product Sciences, GlaxoSmithKline will discuss bracketing strategies for filing in the Japanese market, as an approach to address post-approval changes during the initial application process.