For most of its history, PDA has interacted with global regulators by providing comments to draft publications. Most global health authorities have a process of developing new laws, regulations, guidelines or guidances that require public input. PDA has actively responded on behalf of its members, representing their scientific and technical interests to regulators, and is recognized for preparing scientifically sound comments that focus on issues with the potential to significantly affect the regulatory arena for years to come.
In order to best serve PDA members and the industry, make efficient use of PDA resources, and maximize the impact of the comments, the Regulatory Affairs/Quality Advisory Board (RAQAB) has defined a scope and process for regulatory commenting that aligns with the interests of PDA. This commenting process begins with surveillance of draft guidance documents, proposed changes or additions to GMP regulations, and other health authority announcements. Publications relating to technical areas such as aseptic processing, manufacturing and testing, process engineering, biotechnology, microbiology and process validation are specifically targeted for PDA response and comments. Quality and regulatory documents related to compliance, GMP, supply chain, quality systems, and content and format of CMC submission dossiers are also generally accepted for commenting. Health authority publications outside this scope are generally not considered for comment unless there are special circumstances warranting a response. RAQAB has defined documents related to clinical trial sponsorship, investigational drug treatments, labeling and medical error prevention as out of scope for PDA commenting. PDA generally focuses on regulations and guidance relating to drug products, both small and large molecule, however, draft documents related to combination products, vaccines and veterinary products may be considered for comment if they are within the scope areas noted above. Refer to Figure 1 for an outline of the steps PDA takes when choosing to comment.
Figure 1 - PDA Decision to Comment
The primary sources of the documents on which PDA comments are the U.S. FDA, EMA, Japanese Ministry of Health, Labour and Welfare/PMDA, ICH, PIC/S and WHO. In 2013, PDA developed a process to submit comments to publications originating in “BRICK” countries (Brazil, Russia, India, China and Korea). Because these documents are generally published in a language other than English, additional time and translation steps are needed to complete these comments. PDA is actively looking for publications from these regions that fit within PDA’s scope.
Once a proposed document is found to be within PDA’s technical scope, the following criteria are considered in making a decision to form a task force and begin the commenting process.
- Relevance to and impact on PDA’s core competencies and mission, (e.g., parenteral products and quality-related regulations and guidance)
- Scope and impact of the issuing regulatory authority (e.g., EMA and FDA will generally be of higher impact than other national authorities.)
- The amount of time available to complete the commenting process (In general, 60 days from the time the document is submitted to PDA is the minimum required. Expedited timelines are possible depending on the nature of the document and the engagement of the commenting team.)
- The need for translation of PDA’s responses into a local language before the submission (in some cases, the brevity of timelines or lack of available subject matter experts prevent PDA from preparing comments or require an expedited process.)
When a decision is made to accept a document for comment, PDA establishes a task force generally overseen by RAQAB. The Biotechnology Advisory Board or the Science Advisory Board may be designated as the lead advisory board when the nature of the regulatory document is highly technical or scientific. In this case both the lead advisory board and the RAQAB will ballot on the final comments. Each task force includes at least one representative from the lead advisory board. The remaining members of a commenting task force can be any PDA members with appropriate expertise and commitment to meet the deadlines. It is important to have task force members representing a broad perspective geographically and scientifically so that the resulting comments truly represent a consensus opinion. In cases where very specific expertise is required, even nonmembers may be invited to participate.
Anyone with interest in participating on a commenting task force should note that in a Volunteer Interest Profile submitted to Jonathan Hill, the PDA Volunteer Coordinator, at [email protected].
Because PDA regulatory comments are official positions of the organization, each one is formally balloted through the RAQAB and then through the Board of Directors. At each ballot stage, board members have an opportunity to provide feedback and request revisions to the comments.
The PDA regulatory commenting process continues to be the starting point of important dialogue between the association and health authorities. In 2013, PDA comments related to FDA’s request for quality metrics opened up the door to more discussion with the FDA and eventually resulted in the 2013 PDA Pharmaceutical Quality Metrics Conference and subsequent Points to Consider document. [Editor’s Note: See the cover story for the February 2014 PDA Letter.] PDA’s comments on the EMA’s shared facilities draft guideline led to PDA being invited to participate in an EMA interested parties meeting on the topic, also in 2013. These are just two examples of how PDA’s regulatory commenting contributes to the PDA mission of connecting people, science and regulation©.
PDA members at large, chapters, interest groups and members of other Advisory Boards are welcome to submit publications for potential comment to the following:
Sue Schniepp, RAQAB Chair ([email protected])
Jeff Broadfoot, RAQAB Vice Chair ([email protected])
Denyse Baker, PDA staff liaison to RAQAB, ([email protected])