Bethesda, Md., July 28, 2017 – The Parenteral Drug Association (PDA) today announces the results of its pharma/biopharma survey regarding the impact of national-level post-approval change regulations on company’s ability to innovate. Respondents nearly unanimously (97%) identified these regulations as hurting the innovation and holding back technological progress. PDA’s Task Force on Post-Approval Changes: Innovation for Availability of Medicines (PAC iAM), conducted the survey.
“It is unavoidable in the long commercial life of drug products for companies to make manufacturing changes, both to continually improve processes and to address normal issues,” said Richard Johnson, PDA President. “The PAC iAM task force strives to open a global dialogue on deleterious effects of a non-harmonized post-approval changes regulatory environment with the ultimate goal of finding a science-based, risk-based solution.”
To that end, the PAC iAM is holding a workshop September 13-14, following the 2017 PDA/FDA Joint Regulatory Conference, at the Renaissance Washington Hotel (Washington, DC). The group is also preparing a PDA Technical Report on post-approval changes that will present practical aspects of PAC management and include representative protocols for different types of changes.
More on the PAC iAM task force’s efforts can be found at https://www.pda.org/conference/pac-iam/home.