Determine Where You Are Going to Sell Early On

What your product is matters in addition to where you are going to sell your product. While some of the biomedical regulations are now becoming more consistent across borders, there are still many differences that can impact how you must collect biological materials and what is required for a final GMP grade product. The regulatory documents required, and processing / approval times vary depending on the country and the product. Once you know your target sales area(s), you can build the requirements into the manufacturing process at the onset.

Get the RIGHT Help

Find a consultant/expert who knows and uses the Code of Federal Regulation’s, the EU Annex and ISO manuals as source references. If you find that your expert constantly needs to call others for advice, you’re on the wrong path. If your expert is not using the CFR’s (and similar), there is no way to determine the true regulatory boundaries and/or find creative ways to adhere to the regulation(s) yet still manufacture your product.

Map Out Your Regulatory Path

Create a flow chart outlining your entire manufacturing process, then step by step document the related regulations. This not only helps you understand the regulatory requirements for the process but could help you identify multiple alternative options.

After you understand the regulations for the manufacturing process, map out the regulatory requirements like:

  • Do you need to register with FDA?
  • Do you need to be licensed?
    • Which agency/ies will license you?
    • Do you need special permissions?
  • Do you need accreditation from the College of American Pathologists (CAP), CLIA, American Association of Blood Banks (AABB), Plasma Protein Therapeutics Association (PPTA), etc?
  • Do you need to prove the safety and effectiveness of your new product through a clinical trial?
  • Do you need a new drug application?
  • Do you need IRB approval / oversight?
  • Are there specific staffing requirements necessary?

 Get on the Fast Track

The FDA has created Four Expedited Processes for Drug and Devices important to Public Health. Understanding these FDA requirements helps you to take advantage of this important program and get your new drug or device to market as quickly as possible.

Fast Track: A process designed to facilitate the development of and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Break Through: A process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy/ies.
Accelerated Approval: These regulations allow drugs for serious conditions that fill an unmet medical need to be approved based on a surrogate endpoint.
Priority Review: This designation means FDA’s goal is to take action on an application within 6 months.


Plan Ahead

There are some regulations that are not necessarily required by the FDA, but may be required by ISO, European Medicines Authority, PPTA or other regulatory authorities. It is important to understand that these regulatory bodies are actively working to create harmony between organizations for the future, but as of now, there are some substantial differences. When possible try to anticipate probable multi-country relationships and implement the most stringent standards from the beginning. One of the easiest mistakes to make is to assume that your current items such as equipment and software will be acceptable in another country.

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