General documents
Group I
Group II
Group III
1. Application form & appropriate checklist
Required
Required
Required
2. Application fee
Required
Required
Required
3. Personal information of the person-in-charge of the company
Required
Required
Required
4. Documentary proofs of manufacture or sales history of the product
Required
Required
Required
5. Copy of manufacturing authorization issued by the country of origin (if applicable)
Required
Required
Required
6. Copy of free sale documentation of the product issued by the country of origin (if applicable)
Required
Required
Required
7. Product samples and prototype sales pack
Required
Required
Required
8. Label & package insert that have complied with the laws
Required
Required
Required
9. Master formula
Required
Required
Required
Product safety documents
Group I
Group II
Group III
1. Heavy metals and toxic elements test report
Required
Required
Required
2. Pesticide residues test report
Required
Required
Required
3. Microbial limit test report
Required
Required
Required
4. Acute toxicity test report
Required
Required
Required
5. Long-term toxicity test report
Required
Required
6. Local toxicity test report
7. Mutagenicity test report
Not required
8. Carcinogenicity test report
Not required
9. Reproductive and development toxicity test report
Not required
10. Summary report on product safety documents
Required
Required
Required
Product efficacy documents
Group I
Group II
Group III
1. Interpretation and principle of formulating a prescription
2. Reference materials on product efficacy
Required
Required
Required
3. Principal pharmacodynamic studies report
Not required
Not required
Required
4. General pharmacological studies report
Not required
Not required
5. Clinical trial protocol and summary report
Not required
Not required
Required
6. Summary report on product efficacy documents
Required
Required
Required
Product quality documents
Group I
Group II
Group III
1. Manufacturing method
Required
Required
Required
2. Physicochemical properties of crude drugs
Required
Required
Required
3. Product specification, method and certificate of analysis
Required
Required
4. Accelerated stability test report or general stability test report
Not required
Not required
5. Real-time stability test report