Clinical Trials
- Renewal of Authorization of a Clinical Trial
- Innovations & Research inquiry form
- Clinical Trial Application Form
- CTA Amendments Screening Form
- Initial CTA Screening Checklist
- CTA Renewal Screening Form
- Format of clinical trial report
- Application Form for Amendment of Conditions of a Clinical Trial
- Format of report for terminated clinical trial Regulation 12 (5)
- Letter of authorization from holder of patent of a drug, licensed person or manufacturer of drug
- Declaration by principal investigator
- Declaration by monitor
- Declaration by sponsor and principal investigator of funds of the clinical trial
- Pharmaceutical data on dosage form
- Application for additional investigators
- Labelling investigational drug products for clinical trial
- Format for investigators brochure
- Format for clinical trial protocol-Regulation 4
Drugs Promotions
Field Trials
- Required Documents by the Authority Inspector at the Port of Entry for Conduct of Ectoparasiticide Trials
- The Ectoparasiticide Trial Application Format (ETAF)
- The Contracted Research Organization Administrative Information for the Ectoparasiticide Trial
- Format for the Ectoparasiticide Trial Protocol
- Format for Declaration by the Investigators for for the Ectoparasiticide Trial
- Format for Labeling Ectoparasiticide Trial Products
Surgical Instruments
- Classification rules for surgical instruments and appliances
- Application submission checklist
- Application form for Variation / alteration of a registered surgical instrument/appliances
- Essential principles checklist in registering of surgical instruments and appliances
- Application form for the registration of surgical instruments
