Bethesda, Md., September 19, 2016 – The Parenteral Drug Association (PDA) has announced its program to reduce hurdles to pharmaceutical manufacturing innovation caused by disparate national regulations that discourage changes. Current disharmonized national and regional “post-approval changes” regulations require companies to submit filings with agencies worldwide in order to gain permission to make most kinds of manufacturing, analytical methods and process changes. In many cases, the process takes several years, and manufacturers must produce multiple batches of the same product while they await approval for a change in one region/country, which has already been approved in others.
A PDA Post Approval Change Innovation for Access to Medicines (PAC iAMsm) Task Force of volunteer industry experts has issued a call to action, inviting the broader pharmaceutical industry and regulatory community to join with them in tackling this “wicked problem.”
“The challenge of managing various requirements and timelines to initiate manufacturing improvements has had the unintended consequence of stymieing innovation,” stated PDA president Richard Johnson. “As facilities and processes age, they are not keeping up with current technologies and practices, which in many cases lead to manufacturing stoppages and plant shutdowns and ultimately the very serious public health problem of drug shortages.”
PDA’s task force has the following objectives:
- Bring awareness to current challenges and enable stronger collaboration amongst opinion leaders and key stakeholders (within industry, regulatory authorities and other relevant stakeholder forums).
- Foster a science and risk-based approach to PAC management and regulatory decision making for global product quality, safety, and efficacy assessments
- Encourage international convergence / standardization in PAC management in a manner that can foster and enable mutual reliance between regulatory authorities
- Manage PACs through the use of an effective Product Quality Systems (PQS)
PDA will produce several position papers for the PDA Journal of Pharmaceutical Science and Technologyover the coming months. It also will be conducting an industry survey to gather information to support a future PDA technical report and examples of global PAC protocols on the topic.
PDA’s PAC iAM Task Force
|Anders Vinther, Sanofi Pasteur (co-lead) |
Ursula Busse, Novartis
Marcello Colao, GSK Vaccines
Maik Jornitz, G-CON
Morten Munk, NNE Pharmaplan
Melissa Seymour, Biogen
Denyse Baker, PDA
|Emma Ramnarine, Roche/Genentech(co-lead) |
Franck Chassant, Sanofi Pasteur
Julia Edwards, Biogen
Marina Kozak, Friends of Cancer Research
Mihaela Simianu, PharmaCore Insights
Rich Levy, PDA