How to Determine Whether to Comment on Regulatory Documents

beiwei5du

How to Determine Whether to Comment on Regulatory Documents

Posted 26 January 2018 | By

By Kimberly Belsky, Emily Huddle and Elizabeth Rosenkrands-Lange

This article addresses the question whether to submit comments to health authorities regarding new regulatory documents or proposed changes to existing documents. The authors provide several considerations for making such decisions as well as ways of determining if the submitted comments have been "successful."

Introduction

When deciding whether it is useful or beneficial for a company to offer comments on a new or revised regulatory document, a number of factors should be considered. The first factor to consider may be the relative importance of maintaining a collaborative relationship with Health Authorities (HAs). Taking advantage of the opportunity to comment may help to ensure regulatory proposals contain current technical requirements and the practical and efficient processes for adoption and implementation as well as the flexibility necessary to reduce regulatory burden. Commenting may be a form of "collaboration," providing an essential step for the HA to ensure their proposals contain current insight into emerging technologies, scientific principles and patient perspectives. However, whether to comment or not comment remains an open question and the old adage "work smarter, not harder" may provide help.

Working Smarter

When deciding whether to submit comments in response to a new or revised regulatory document open for comment, a number of factors should be considered. Most considerations relate to both a comment's potential impact on the company offering the comment and the effort required to offer comments - Figure 1.

Figure 1. Whether to Comment on Regulatory Documents: Factors to ConsiderCompany Philosophy

Offering comments may be part of a company's philosophy for maintaining a voice with the HA or industry trade group. While there may or may not be a formalized company position, policy and/or dedicated staff to facilitate or lead the process internally, there is generally a dedicated role or function for external communications to serve as the first point of contact for commenting.

Support from Management and Defined Roles and Responsibilities

When considering whether to submit comments directly to a HA on behalf of the company, it is critical to have the endorsement and approval by management in legal and communications, as well as approval from heads of the functional areas related to the comment's subject area. Because comments may be made public and picked up in the trade press, defining and communicating roles and responsibilities must be part of the process to avoid submission of "unauthorized" comments by well-meaning company representatives. Having clearly defined roles and responsibilities for coordinating and submitting comments are, of course, essential to the process.

Engagement with Trade Associations

If a company belongs to a trade association, it is important to be aware of, and engaged in, the development of the comments proposed by the trade association. A company may choose to submit comments separately if the company position is not aligned with the trade association or if the company wants to emphasize or enhance a specific issue in the trade association's response. Based on the sensitivity of the comment or the company resources available to prepare and route comments for approval to meet the commenting deadline, a company may choose to comment only via the trade association. The decision as to whether the company will comment should be flexible, as a trade association's position may evolve during the commenting period. For either approach, it is important to ensure key stakeholders and subject matter experts are identified early and" looped" into commenting activities.

Proposed Document Business Impact

It is important to consider the potential impact of the proposal(s) on the company portfolio. One should consider the disease areas the company is investigating or has plans to investigate in the future. Does the proposal raise the regulatory burden and/or subsequent compliance considerations in the future? Or does the proposal represent a significant cost to the company in terms of additional planning or resources to implement?

Time Requirements

A decision to comment also depends on having the time available to collect, collate, edit, review, approve, and submit comments. The consideration of time also may include the costs associated with translating consultation documents and comments. Also consider conflicting company priorities and the timing and resources associated with the priorities. In some cases, submitting comments via trade association can reduce the overall resource burden while simultaneously ensuring the company's position is represented. In some countries, such as Japan, comments to the Pharmaceuticals and Medical Devices Agency (PMDA) must be submitted via a trade association in order to be considered by the agency.

Creating Well-Reasoned Comments and Recommendations

It is essential for key stakeholders and subject matter experts to be engaged in the initial assessment of a consultation document as well as the decision to comment or not. Subject matter experts are best poised to identify significant issues within the proposal as well as any opportunities to enhance its content by including specific examples and recommendations.

It is also critical to develop and communicate a well-defined timeline for developing comments, collating the draft comments, carrying out comment review(s), and finalization based on the comment closing date. Using a commenting template may help ensure comments have been cross-referenced to the appropriate section of the document and summarizes the issue and recommendation. One may refer to the European Medicine's Agency commenting template for an example.1

Improve the Chances of Success

Thoughtful, well-informed comments can help ensure the company's positions are being considered by the relevant HA. Again, it is essential to involve key stakeholders to ensure the company's submitted comments and recommendations are based on correct and current scientific and technical knowledge and the expertise needed to advance patient safety and availability of medical products, yet not increase the regulatory burden unnecessarily. After ensuring the appropriate individuals are included from a technical standpoint, an editorial review is an essential (but sometimes overlooked) step for creating a clear, concise and grammatically correct response. Since comments submitted to the HA are often made publically available, the overall condition and tone of submitted comments are important to the public's perception of the company. Below are suggestions that could be implemented as a checklist or best practices guide to ensure the company's best effort when submitting comments to the HA.2

• Comments should always be written utilizing correct grammar and spelling.
• Ensure comments are clearly and concisely written.
• The consolidated response should be consistent in terms of content and style.
• Abbreviations and acronyms should be spelled in the first instance and followed by the abbreviation in parentheses.
• Ensure comments are factual and constructive. Avoid focusing on a document's shortcomings without recommending solutions.
• Comments should fall within the scope of the consultation document.
• Ensure referenced text within the consultation document is designated with the respective page number, section heading, paragraph number and/or line number.
• Provide robust arguments by including any information that helps to support the rationale of a stated position.
• It is always preferable, where feasible, to supply suggested wording or recommend specific changes rather than using open ended requests for "additional information" or "further clarification."
• Avoid focusing on minor spelling or editorial issues as this may dilute key messages in the submission.
  

Defining Success and Commenting Metrics

Even if the company has the resources required for developing robust comments, it can be challenging to measure the value of submitting comments. It may even be more difficult to quantify any "return on investment" gained from commenting. Because companies may define commenting's added value and "success" differently, it is critical to determine how the success of submitted comments is defined. Success could be measured by whether the HA incorporated a company's comments into their final document. However, unless a single company is the sole commenter on a specific topic, it may be difficult to assign success to one specific commenter. This is especially true if a company is part of an industry trade association submitting similar or the same comments. For some, having a voice and ultimately creating a positive outcome is considered a success.

Benefits of Commenting and a Review of Comments Submitted

Commenting provides an opportunity to help shape the evolving regulatory environment and having the company's voice heard in that evolution. Further, assessing the document with a rigorous view to identifying new challenges, such as increasing regulatory burden, inconsistencies or opportunities, such as reducing regulatory hurdles, allows a company to prepare for coming changes. Submitting clearly articulated recommendations and a rationale for the change also can help the company define its interpretation and prepare for a best case/worst case analysis once the document is finalized. Taking this strategic action can be invaluable to the programs and compliance.

Whether a company chooses to submit or not submit comments, it is important for a company to review others' submitted comments when made available. These comments can provide insight into other issues the company may not have considered and further enhance the interpretation of new or revised proposals so that they may be mitigated or provide planning opportunities.

Summary

Offering comments on proposed regulatory changes is an important step in helping to shape the regulatory environment. Submitted comments should include recommendations on how to enhance the document, and when appropriate, include examples from other global health authorities that may help to reduce regulatory burden. Even if a company does not submit comments, a review of publicly made comments can provide additional insights into the interpretation as well as contribute to the company's readiness for issuance of a final version.

References

• The European Medicines Agency Submission of Comments Form. EMA website. www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500004016.doc. Accessed 22 January 2018.
• EU Regulatory Intelligence Networking Group (RING) Members. "Providing Good Quality Comments on Consultation Documents." The Regulatory Affairs Journal Pharma, June 2008, pp. 389-390. http://communities.diaglobal.org/HigherLogic/System/DownloadDocumentFile.ashx?DocumentFileKey=c80887d5-58f5-4ccf-bfb7-5874d32429cd. Accessed 22 January 2018.
  

About the Authors

Kimberly Belsky, MS is the senior director, regulatory policy and intelligence, regulatory affairs for Mallinckrodt Pharmaceuticals, chairperson for the DIA Working Group on advertising and promotion. Belsky has more than 16 years of experience in regulatory affairs and can be reached at kimberly.belsky@mallinckrodt.com.

Emily Huddle, BSc, is US regulatory intelligence manager for Gilead Sciences, Inc. and co-chair of the DIA Regulatory Intelligence Working Group. Huddle has worked in the pharmaceutical industry (both human and veterinary) for more than 20 years, including 10 years in regulatory intelligence. She can be contacted at Emily.Huddle@gilead.com.

Elizabeth Rosenkrands-Lange, MS, MPH, is a senior manager, regulatory policy and intelligence at LEO Pharma Inc. and co-chair of the DIA Regulatory Intelligence Working Group. Rosenkrands-Lange has worked at FDA and she has worked in regulatory policy and intelligence for six years. She can be reached at ehrdk@leo-pharma.com.

Cite as: Belsky, K., Huddle, E. and Rosenkrands-Lange, E. "How to Determine Whether to Comment on Regulatory Documents." Regulatory Focus. January 2018. Regulatory Affairs Professionals Society.

beiwei5du

以前有附到的查看FDA的相关comments的入口：
如何查询FDA法规文件的制定历程，背景以及来自各方的评论建议
https://www.ouryao.com/forum.php?mod=viewthread&tid=395965&highlight=federal

EU的入口在：
https://ec.europa.eu/health/consultations_en
EU EMA也经常会发布相应的comments overview

无饿不坐

谢谢分享、楼主辛苦！

syhorchid

学习一下

syhorchid

谢谢分享

Aster205

谢谢分享

小金库

好资料，学习借鉴