MaRS Library Step 9: Collate your regulatory submission
Healthcare product development is complex. It is critical to know the general product development lifecycle so that you can follow the correct path. Knowing which pitfalls to avoid will speed your time to market. This article outlines step 9 of the 10 steps to develop a healthcare product.
In the development of a healthcare product, the regulatory submission is intended to “tell a story” about your product1. Depending on your product and the submission type, it may include information on the following:
- The raw materials or active substance used
- The formulation of the drug or biologic, or the design of the medical device
- The manufacturing, processing and packaging
- The results of non-clinical tests (fo example, bench, in vitro or in vivo animal studies) and/or clinical trials
- How the product behaves under its intended use
These data should support the product’s label, which is designed for use by medical professionals as well as the general public. The product label forms the basis for marketing and advertising activities.
A regulatory submission is thus a complex document and it contains input from multiple technical areas. Often, data that supports the quality, safety and efficacy/effectiveness of the healthcare product are collected throughout many years of product development. Thorough planning and management of these data are required to present them logically in terms of continuity and connectivity while at the same time speaking in a single voiceabout your product.2
Typical stages of the regulatory submission process
The following outlines the typical stages of the regulatory submission process:
1. Pre-submission meeting
Although not mandatory, a pre-submission meeting is a key step in achieving a successful submission. To arrange a meeting, submit a meeting request and a pre-submission package to the relevant regulatory bodies. For more information on pre-submission meetings, please see the article Pre-submission regulatory meetings: Preparation.
2. Submission planning and compilation3
Assembling a regulatory submission is a lengthy process. Although such a document will be submitted at the end of the product development process, the compilation of the submission should begin and continue throughout the product development program. Consider implementing the following as part of your compilation procedures:
- Develop a detailed regulatory submission plan identifying the individual tasks (for example, generation of study reports, submission summaries), timelines and the individuals responsible for authoring, reviewing and approving the various sections of the application.
- Have each section authored, reviewed and approved by the relevant technical functions―that is, quality, medical, non-clinical, clinical, manufacturing, engineering and regulatory. Ensure discussions on the product quality, safety and efficacy/effectiveness focus on supporting the proposed indication.
- Generate submission sections in accordance with regulatory requirements, and tie different sections together through the use of summaries and navigational features (for example, tables of content, cross-referencing statements).
- Ensure the completeness of the submission content by using the regulatory submission’s table of content as your checklist.
For more information, please see the article Healthcare product submission: A primer.
Ensure all regulatory submissions adhere to the stipulated format, and publish the required number of submission copies. Review all information carefully to ensure nothing is missing or misplaced. All specifications for a regulatory submission (particularly for an electronic submission) should be met to ensure it is acceptable to the regulatory agency.
4. Submission of documentation
5. Post-submission activities4
After the submission is filed, be prepared to respond to the agency’s questions or requests for additional information (this may occur at the submission screening and/or at review stages). Ensure that your responses are submitted within the timeframe indicated to avoid the risk of your submission being withdrawn. Pre-approval inspections (re: Good Manufacturing Practices [GMP] or biomonitoring, for example) for some products (such as drugs, biologics or premarket-approval [PMA] devices) may also take place prior to an approval being issued.
6. Product approval/clearance
If the review is satisfactory, the regulatory authorities will grant a marketing authorization or clearance to enable commercial sales to commence.
Read the next step in the 10 steps to develop a healthcare product: Step 10: Ensure post-marketing compliance
Read the previous step: Step 8: Collect your data for regulatory submission
The information presented in these articles is intended to outline the general processes, principles and concepts of the healthcare product development lifecycle. Since regulatory requirements are ever-changing, it is current only as of the date of publication and not intended to provide detailed instructions for product development. Every healthcare product is unique and therefore so is its associated product development lifecycle. Specific advice should be sought from a qualified healthcare or other appropriate professional.
Published: October 17, 2012
- U.S. Food and Drug Administration. (2012, May 18). New Drug Application. Retrieved September 18,2012, from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm
- Manuts, D.S. (2008). Chapter 11. The practice of regulatory affairs. In Pisano, D.J. & Mantus, D.S. (Eds.) FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics (2nd ed., pp.109-23). New York: Informa Healthcare.
- McPhatter, K., Walch, K., Miller, L. & Kneifel, A. Chapter 27. Assembling and filing the NDA/BLA. In S.E. Linberg (Ed.) Expediting drug and biologics development: A strategic approach. (n.d.) Watham, MA: PAREXEL International.
- U.S. Food and Drug Administration. (2005, April). Guidance for Review Staff and Industry: Good Review Management Principles and Practices for PDUFA products. Retrieved June 6, 2012, from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079748.pdf.