-->

Jun 24, 2014

Creating a Global Regulatory Plan



Having and maintaining strong global regulatory strategy and plans can help your business not only stay in compliance but can be an integral part of corporate market growth strategies.  How many of us have jumped into a new market before fully understanding the regulatory requirements and the potential impact of those requirements?  If you have, you are not alone.  Mapping the requirements as part of your strategic planning may help you identify a great new market or help you avoid a costly mistake.

Before delving any further, we need to make sure we are all using the terms "regulatory strategy" and "regulatory plan" in a similar way.
  • Regulatory Strategy:  aligns the regulatory activities required to bring a new or modified product to market with the business or marketing strategy.  It provides overall direction to the team by identifying the important regulatory elements.
  • Regulatory Plan: Describes specific steps and action required to meet the regulatory strategy objectives. It contains the specific elements required to assemble the regulatory submissions.

The benefits of developing and maintaining effective global regulatory strategies and plans are far-reaching.  Some of those benefits include:
  • Clear communication within project team
  • Clear communication with the management team
  • Clear definition of the required resources (both human and financial)
  • Avoid delays due to new last-minute requirements
  • Improve efficiency
  • Improve accuracy and timeliness of filings
  • Save money because of efficiency improvements and avoidance of delays
  • Help your business stay in compliance
  • Can be an integral part of corporate marketing strategies
  • Identify a great new market
  • Avoid costly mistakes
    • Discover you don’t have some required information and it may be prohibitively expensive to get the necessary information to support a filing for a market.
    • Identify early in the process that the project requires more resources than you currently have available.

An effective strategy or plan is compatible with the business/marketing strategy for the product and the company.  The strategy or plan must also have cross-functional buy-in from at least regulatory, marketing, product development, and executive management functions and must be feasible with the available internal and/or external resources.  It is important to remember that no strategy or plan should be static.  They should be updated as the project progresses or as conditions within the company evolve. 

The strategy should include the following elements: 
  • Define the device or product
    • Will claims be different or the same across markets?
    • Will device risk be the same or different across markets?
  • Defines which markets are of interest preferably with a market analysis to support the viability of the market
  • Type of submission(s) based upon the desired markets
  • Considers life cycle issues that may be applicable

Elements of an effective regulatory plan include the following:
  • Defines the market specific requirements and how those requirements may be met.
  • Defines the submission requirements for each market including timing and any applicable fees.
  • Contains specific project deliverables including timing, responsibilities, and resources.
  • Defines specific testing that may be required such as preclinical and clinical (note this may be different across markets)
  • Defines which standards and/or regulations may be applicable for each potential target market.
  • Defines specific country regulatory references
  • Defines appropriate predicate device(s) if the device will be marketed in the US.
  • Includes the desired claims for each market (possible claims matrix)
  • Includes a plan for how the claims will be supported (labeling, bench testing, clinical, etc.)
  • Contains the specific elements required to assemble the regulatory submission.
  • Defines any special requirements such as facility inspection
  • Defines any anticipated post-market surveillance
  • Describes any pre-sub interaction with regulatory agency officials
  • May be a separate document for each potential market or one global plan for all markets
In order to accomplish cross-functional buy-in and to successfully develop and execute global regulatory plans, it is critical to establish interfaces and to define the roles of each function.  All roles are responsible for clear communications across the project team and with management to ensure that any necessary adjustments can be made in a timely way.  For example, the roles might look something like this, depending upon your organizational structure:
  • Management
    • Provision of resources
    • Provision of strategic direction
    • Visibility to reimbursement landscape
  • Quality
    • Product acceptance activities for pre-production and production product
    • Labeling review and release
    • Post-market surveillance
  • Regulatory
    • Clinical Evaluation Report (CER)
    • Define the regulatory requirements for all markets
    • Identify appropriate guidance, regulations, etc.
    • Define predicate(s)
    • Confirm that all claims are adequately supported
    • Work with marketing and product development to create labeling
    • Assemble/submit applications
    • Post-market surveillance
  • Product Development
    • Define the device and its function
    • Risk analysis
    • Pre-clinical testing
    • Clinical Evaluation Report (CER)
    • Provide technical support for applications
    • Work with regulatory and marketing to create labeling
    • Intellectual property
  • Clinical
    • Clinical testing
    • Clinical Evaluation Report (CER)
    • Post-market surveillance
  • Marketing
    • Define the desired claims and provide support for claims if possible
    • Work with regulatory and product development to create labeling
    • Provide market analysis to help management determine if market is viable
    • Trademarks and copyright
  • Regulatory Agency
    • Pre-submission interaction to define any special requirements if applicable
    • May require post-market surveillance reporting
Now that you know how what elements belong in a global regulatory plan and strategy and understand how important cross-functional collaboration will be to your success, let’s address some common challenges that can arise.

Pressure to get the project started:
  • Starting without at least a draft of a plan typically leads to major delays
  • Contributes to inadequate communication
  • Remind management and project team that investing the time up front will save time later

Scatter approach:
  • Trying to enter every market at the same time, especially without a carefully considered plan, often results in:
    • Insufficient resources to do the work,
    • Significant time delays,
    • Product never getting cleared/approved, or
    • Inability to sell the product despite clearance/approval due to IP, reimbursement, trademark or other similar concerns
Unforeseen setbacks:
  • Much of this can be avoided with a well-conceived plan
  • Sometimes happens anyway
  • Communicate, communicate, communicate
Time overruns:
  • Can often be avoided with a well-conceived plan
  • Get creative about how to get back on track.  Is there a resource that can help in the short term?
  • Sometimes happens anyway
  • Communicate, communicate, communicate
Cost overruns:
  • Can often be avoided with a well-considered plan
  • Sometimes happens anyway
  • Communicate, communicate, communicate
Changes to the regulations:
  • Regulatory changes do happen but typically there is a long lead time
  • Stay abreast of the regulations that can impact your business
  • Subscribe to news that provides updates
  • Subscribe to updates to the FDA website
Difficulty with a regulatory agency reviewer:
  • Establish a professional working relationship with the reviewer that engenders trust
  • Be prompt and professional in responding to any inquiries from the reviewer
  • If you are communicating via email, ask for a phone call to resolve any issues
  • If appropriate, ask a physician to interact with the reviewer to address his/her concerns
  • Make sure you keep accurate records of all interactions with the reviewer
  • Communicate with your project team and management

At the end of the day, effective execution of global regulatory strategies and plans should save your company time and money and may help you get product to the markets more efficiently.  


Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She currently is the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies.  Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), and Association for the Advancement of Medical Instrumentation (AAMI).  She completed the RAPS Executive Development Program at the Kellogg School of Management. She may be reached at cheryl@wagonerconsultingllc.com or at 910-386-9019.






Watch Related Videos

Download Free Resources
White Paper: Foolproof Investigations: A Proven Approach for Root Cause Analysis in a Regulated Environment
Product Data Sheet: MasterControl Process™
Product Data Sheet: MasterControl QMS and QEM Systems
White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance

Related Links