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More than 100 PDA volunteers spent nearly 675 hours developing responses summarizing PDA’s positions on a variety of draft regulations in 2016. In some cases, small teams of three to five experts came together to respond quickly to a pertinent guidance document with only a 30- or 45-day comment window. In other cases, a task force of 16 or 17 members worked for several months to reach consensus on the finer points of a regulation that warranted a thorough response from PDA. In every response, the comments focused on the important scientific/technical concerns posed by the proposed regulation, notably impact on patient protection and product quality.

As shown in Figure 1, PDA responded to comments from multiple regulatory agencies around the world, primarily to documents published by the U.S. FDA, EMA, the UK MHRA, and WHO. PDA is open to responding to documents from other regulatory agencies provided they fall under the Association’s specialized areas of aseptic processing, validation, manufacturing, biotechnology, GMP/compliance, supply chain, and quality systems, among others.

Figure 1 PDA Regulatory Commenting Activity

Each regulatory agency has a different process and timeline for collecting comments. Sufficient lead time for comments is one of PDA’s criteria for determining whether or not to comment as the Association relies on volunteers with appropriate expertise. These volunteers must then be available during the commenting period. PDA’s internal balloting procedures for regulatory comments make it difficult to respond to regulatory proposals with commenting windows less than 60 days.

One of the important principles of PDA comments is to facilitate a common understanding and approach. Commenting task forces usually cite existing standards and technical guidance, encouraging the regulatory body in question to use these within the document. When applicable, the comments reference scientific principles right out of PDA’s technical reports. At a recent PDA workshop in Dublin, both FDA and EMA investigators stated their support for referencing PDA technical reports in responses to regulatory documents. PDA comments are also valued by regulators. At times, PDA has been invited directly by authors from individual regulatory agencies to comment on draft guidelines. One agency even asked PDA to submit additional detailed responses on specific issues following the submission period.

The Regulatory and Quality Advisory Board (RAQAB) also tries to determine the impact PDA’s official comments have on the final regulatory guidance documents. Although it could be several months, or even years, between the open comment period and publication of a final guideline, PDA retains a record of the Association’s comments on each specific document. Task force members then compare the draft and final versions of the regulatory document to evaluate how many of PDA’s comments were incorporated into the final version. From these observations, RAQAB has ascertained that about 50% of PDA’s comments are accepted on average. Still, results for individual regulatory agency documents vary.

Once a task force has completed its draft, the responses are balloted by one of the three PDA Advisory Boards—Regulatory and Quality Advisory Board (RAQAB), Science Advisory Board (SAB) Biotechnology Advisory Board (BioAB)—with RAQAB balloting the majority. In 2016, RAQAB balloted 13 of the 16 commenting ballots. Following resolution of any Advisory Board questions, the responses proceed to the Board of Directors for ballot. Only after this final step can the document be considered the official position of the Association. Through this process, PDA ensures the highest level of technical content in each response and also consistency with PDA’s values and mission.

PDA commenting task forces are open to any member with an interest and expertise in the topic of the draft publication. Requests for volunteers are sent out to the Advisory Boards and frequently posted to PDA Connect^SM in the most relevant interest group forum.

Overall, the commenting process is one way for all members to participate in the PDA mission of advancing manufacturing and regulatory science and support the PDA values of science, integrity and inclusion.