PDA Launches Effort to Harmonize Global Post-Approval Changes Protocols 22 September, 2014

Bethesda, Md., September 19, 2014 – The Parenteral Drug Association (PDA) is moving forward with an initiative to harmonize global post-approval changes protocols.

The new initiative stems from the high level of interest in the topic expressed by industry participants and regulatory authority representatives at the PDA Drug Shortages workshop, held earlier this month in Washington, DC. Representatives of both the U.S. FDA and EMA were on hand for the workshop. Attendees indicated openness to engaging regulators and industry in further dialog on ways to expedite post-approval changes as a preventative measure for drug shortages, which in recent years has become a high priority for regulators.

“By establishing common global change protocols, we will be able to facilitate further harmonization across the various health authorities in terms of expediting changes to manufacturing processes, equipment and other processes for marketed products,” said PDA President Richard Johnson. “This would help mitigate potential drug shortages arising from typically extended change approval periods due to often varying approval requirements and processes between different Health Authorities.”

PDA is forming a Task Force to establish common global change protocols for typical types of manufacturing changes and providing a template for post approval change management plans will be one important tool. Companies could submit these prospectively to discuss planned changes across multiple Health Authorities. The goal is to help incentivize companies to implement new technologies and to continually improve product quality and process capabilities and to address the risk of drug shortages caused by aging manufacturing and analytical technologies.

The workshop was the most comprehensive industry and health authority event on drug shortages prevention. The well-attended meeting had presentations and active dialog between representatives of large and small pharma and the U.S. FDA and the EMA. Industry representatives shared their collective experiences, knowledge, and ideas on how to ensure uninterrupted supply of safe, efficacious medicines to patients. Full conference proceedings will be available soon.

PDA announced other aspects of its activities to help companies manage and prevent drug shortages at a press conference prior to last week’s workshop, including the development of a product-focused, risk-based framework described in a Technical Report due out later this year.