RT Journal Article
SR Electronic
T1 PDA PAC iAM 2017 Survey on Post Approval Change Is the regulatory environment hindering much needed innovation in the Pharma Industry?
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2017.008219
DO 10.5731/pdajpst.2017.008219
A1 Seymour, Melissa
YR 2017
UL http://journal.pda.org/content/early/2017/08/16/pdajpst.2017.008219.abstract
AB As part of the effort to identify, assess and address current barriers to PACs, the PDA administered a global, blinded, cross-functional survey to document industry experience with PACs in the current global regulatory environment, and to better understand the regulatory complexity and burden on the industry. The survey interrogated on specific points related to annual volume of PACs, reasons, time commitments/cycle time, impact of regional differences on change implementation, current use of tools (e.g. PACMPs), impact on supply chain complexity (e.g. inventory, variants to manage, non-compliance to filings, drug shortages), manufacturing innovation, and resources needed.