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 3 of the 10 steps to develop a healthcare product.
In order to introduce a new healthcare product or technology to a market, many important factors need to be considered and evaluated, including market size, pricing and reimbursement, medical practices and distribution activities. In addition to this, thorough knowledge of the regulatory requirements of the jurisdiction(s) is critical in order to have a successful and efficient product development program. These regulatory requirements should be identified upfront (that is, early on in the development process) and reviewed periodically to ensure that any changes in the regulatory environment as well as any new scientific technologies are taken into account. This can then be incorporated into the development program so that the necessary scientific data support the licensing review process.
There have been significant improvements in the harmonization of international technical requirements through the work of the International Conference on Harmonisation (ICH), the Global Harmonization Task Force (GHTF), and standards-development bodies (for example, ISO, IEC, ASTM). However, many jurisdiction-specific requirements still exist as regulatory systems were developed independently in different countries. It is well recognized that such differences pose a barrier to the introduction of new products in terms of time and money.1
Know your healthcare market
It is critical to know your market! The last thing any company would like to hear from the licensing review process is that additional information is required to demonstrate the quality, safety or efficacy/effectiveness of your healthcare product because the target country’s requirements have not been addressed.
For example, a regulatory agency may not accept a clinical trial that was conducted in a “foreign” country that did not address the targeted country’s requirements,2 or it may find that the source material of a biological product was not appropriate because it was sourced from a country that causes concerns regarding transmissible spongiform encephalopathy (TSE) or Creutzfeldt-Jakob disease (vCJD),3 or it may advise that the standard followed in the testing of a medical device has been withdrawn by the agency.4 Such outcomes could have a huge impact on the product approval timelines and cause delays in any subsequent launch and marketing activities, which would bring revenue to the company.
What to know for different jurisdictions
When reviewing the regulatory requirements for different jurisdictions, make sure to find out the following:
- What are the harmonized technical guidance documents that can be followed?
- Are there any jurisdiction-specific requirements?
- Are there any product-specific or disease-specific guidance documents? If so, are they also applicable to other countries?
- Are there any programs that can facilitate product development and reduce time and cost to market?
Programs to facilitate healthcare product development
Other than verifying the data requirements to support licensing activities, check if there are any programs available that can facilitate the product development. Many jurisdictions offer programs to support sponsors in developing healthcare products that are targeted for life-threatening conditions that have unmet medical needs. Examples of these programs may include orphan drug designations; fast-track, priority or accelerated reviews; or scientific advice or protocol assistance. If eligible, companies should take advantage of these programs and work with the regulatory bodies to bring these products to market in a timely fashion. In addition, fee reductions and waivers are also available for businesses that qualify as small- and medium-sized enterprises (SMEs).5
Summary: Think globally, act locally
To support your product development program, identify and review regulatory requirements from international groups as well as the country-specific requirements related to your healthcare product.
Read the previous step: Step 2: Identify your healthcare claim and product label
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
- Tobin, J.J. & Walsh, G. (2008). Chapter 2. Regulatory strategy. In Medical product regulatory affairs. Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA.
- 1.2. U.S. Food and Drug Administration. (2001, March). Guidance for Industry – Acceptance of Foreign Clinical Studies. Retrieved September 26, 2012, from http://www.fda.gov/RegulatoryInformation/Guidances/ucm124932.htm
- European Commission. (2011). Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev. 3). Retrieved September 26, 2012, from http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003700.pdf
- U.S. Food and Drug Administration. (2007, September 17). Frequently Asked Questions on Recognition of Consensus Standards. Retrieved September 26, 2012, from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm074973.htm
- Tobin, J.J. & Walsh, G. (2008). Chapter 8. Variations in drug authorization process. In Medical product regulatory affairs. Pharmaceuticals, diagnostics, medical devices. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA.