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 ConnectSM 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.