"Begin with the end in mind" has become a popular catchphrase, but only because it proves itself to be true time and time again. You can more easily comply with regulatory requirements by expending increased effort into your target product profile. This is the foundation of your regulatory strategy and sets the stage for future development considerations. It is the second of ten elements of regulatory strategy:
Creating a target product profile starts by having the end, that is, commercial success, in mind. It defines your product's -
Aside from these three critical definitions, a criteria checklist can help further outline information you should know and document about your product:
By responding to each of these items for your compound, you complete your profile in a way that helps you visualize the market-to-market realities, especially if you plan to file for regulatory approval in multiple countries.
The target product profile also serves as the foundation for your clinical trials-their design, location of patient recruitment. By mapping trials to each checklist criterion, you essentially optimize study design and specify your data requirements to support each attribute. Doing this can also more efficiently leverage your research budget and move your molecule forward.
The target product profile, a key element of regulatory strategy, also enhances product labeling. You can list label elements-such as indication, population, superiority/inferiority, time to effect, boxed-warning, contraindications, warnings/precautions, drug interactions, role of administration, dosing frequency, dosage form, and others-and evaluate each relative to other drugs, minimal criteria for marketability, expected attributes, and attributes that provide additional value.
In evaluating drugs, regulatory agencies across the globe evaluate three characteristics:
When you have collected and analyzed clinical trial data to populate each element of your profile, you are effectively developing your regulatory strategy, smoothing the path for your regulatory filing.
You may decide that your target population includes several countries and regions. Your focus on a target product profile enables you to thread requirements through each criterion. Although country/region-specific regulatory agencies may stipulate different requirements, you should have all the data necessary to prepare your filing documents with confidence.