In the journey of developing a herbal-based product, documentation plays a critical role. Without well-organized scientific, technical, manufacturing, and legal documentation, no regulatory authority will grant licenses for production or distribution. This article provides a comprehensive roadmap for manufacturers, researchers, investors, and graduates in the herbal medicine sector on how to prepare proper documentation for regulatory approval.
In the journey of developing a herbal-based product, documentation plays a critical role. Without well-organized scientific, technical, manufacturing, and legal documentation, no regulatory authority will grant licenses for production or distribution. This article provides a comprehensive roadmap for manufacturers, researchers, investors, and graduates in the herbal medicine sector on how to prepare proper documentation for regulatory approval.
Depending on the activity type, the following licenses may be required:
Industrial or workshop production license from the Ministry of Industry or Agriculture
Food and Drug Administration (FDA) license for herbal medicinal, cosmetic, and dietary products
GMP certification (Good Manufacturing Practice) for quality assurance
Licenses for packaging, export, and plant utilization
Product and brand registration licenses
Complete product formulation
Research data on efficacy, safety, and stability
Laboratory test results and, if applicable, clinical trial data
Supporting academic references and scientific literature
Process Flow Diagrams (PFDs)
Standard Operating Procedures (SOPs)
Equipment and raw material specifications
Quality control records at each production stage
Company registration documents
Intellectual Property (IP) protection, if applicable
Trademark and packaging design certificates
Environmental Impact Assessment (EIA) reports
Material Safety Data Sheets (MSDS)
Staff safety protocols and material storage conditions
Accuracy and completeness: All data must be precise and supported by evidence.
Standard formatting: Documentation should meet the requirements of the relevant authorities.
Regular updates: Any change in product or process must be reflected in the documents.
Consistency: Technical, legal, and scientific documents must align and not contradict each other.
Specialized teams in health accelerators or incubators can support you by:
Assisting in scientific and technical document preparation
Guiding you through the requirements of the Food and Drug Organization
Helping standardize your operations based on GMP principles
Facilitating faster approval through connections and expert reviews
Once documentation is submitted:
Authorities begin scientific and technical evaluation
If gaps exist, revisions or clarifications are requested
Upon approval, licenses are issued
The review period typically ranges from 1 to 3 months if the file is complete
Documentation is not just a regulatory obligation—it’s a strategic asset for building credibility, attracting investment, and entering the market. Herbal product developers should approach documentation with a commercialization mindset and seek support from experienced mentors and health accelerators from the early stages.
