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:
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
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:
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