GRP is documented in the Center for Drug Evaluation and Research (CDER) that describes the process, format, content and/or management of a product review. And that could include medical cannabis
GRP’s were developed as guidance’s for review staff or as manuals of policies and procedures (MAPPs). An example of GRP is MAPP 6010.3 Rev.1 Good Review Practice: Clinical Review Template. This is a standard clinical review template describing the format and content of a new drug application review. GRP policies are updated regularly as advances are being made in science, statutes update, regulations change, and accumulated experience are gathered.
GRPs are developed over time as superior practices based on CDER’s collective experience to provide consistency to the overall review process of new products. GRPs are developed to improve the quality of reviews and review management. GRPs improve efficiency, clarity, and transparency of the review process and review management. GRPs are expected to be adopted by review staff as standard processes through supervisor mentoring, implementation teams, and formal training when necessary.
GRP collaborates policies from various offices within the CDER which include
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Review Management
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Biometrics
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Clinical
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Clinical Pharmacology
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Non Prescription Products
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Safety
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Chemistry
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Manufacturing
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Pharmacology/Toxicology
GRPs fundamental values are quality, efficiency, clarity, transparency and consistency.
If you want to read the full original article, and get some more in-depth details regarding best practices for the cannabis industry, please click here.
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