| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Clinical Trial (CT) Oversight | Receipt, screening and acknowledgement of a Clinical Trial Application (new, renewals and amendment) | 10days |
| Regulatory decision on a Clinical Trial Application | 50days | |
| Annual renewal of ongoing trials | 20days | |
| Amendment of CT Authorisation | 20days | |
| Feedback report to a client following a GCP Inspection | 45days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Veterinary Field Trial Oversight and Pharmacovigilance | Acknowledgement of receipt of a field trial application (FTA) | 10days |
| Regulatory decision on a FTA | 50days | |
| Feedback report to a client following a GCP Inspection of field trials | 45days | |
| Acknowledgement of receipt of safety report | 5days | |
| Feedback on causality assessment | 30days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Marketing Authorization (MA) | GENERAL CONSIDERATION | Working days |
| Assessment of application and request for additional information on application for MA (Human Drugs) | 18 months (396 Days) |
|
| Assessment of application and request for additional information on application for MA (Veterinary Drugs) | 12 months (264 Days) |
|
| Assessment of application and request for additional information on application for MA (Vaccines, Anti-cancer medicines and other vital (medicines) | 6 Months (132 Days) |
|
| Assessment of application and request for additional information on application for MA (Herbal medicines- Imported) | 6 Months (132 Days) |
|
| Regulatory decision on MA after additional information is received | 3 Months (66 Days) | |
| SPECIAL CATEGORIES | ||
| Regulatory decision on MA for domestically manufactured products (Herbal, Conventional) | 6 Months (132 Days) | |
| Regulatory decision on products already authorized for marketing by Stringent Regulatory Authorities and those approved under Article 58 of EU regulations | 6 Months (132 Days) | |
| VARIATION AND NOTIFICATION | ||
| Regulatory decision on minor variation | 4 Months (88 Days) | |
| Regulatory decision on Major variation (if the application does not require physical verification) | 6 Months (132 Days) |
|
| Regulatory decision on Annual or Immediate notification change | 3.6 Months and 2 weeks (80 Days) | |
| DRUG REGISTER | ||
| Publication of drug register | Monthly (5th working day of the month) |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Regulatory Inspection | GMP Physical inspection after receipt of application – Foreign | 180days |
| GMP Report feedback to manufacturer after Inspection | 45days | |
| Feedback after inspection – Domestic | 28days | |
| Regulatory Decision after CAPA – Foreign | 20days | |
| Regulatory Decision after CAPA – Domestic (Local facilities) | 17days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Premise Licensing | Feedback to an applicant on the regulatory decision for pharmacy renewal | 40days |
| Feedback to the applicant on Regulatory decision for licensing of new Pharmacy applicants | 30days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Market Surveillance and Control | Verification of imports (Registered drugs) | 2days |
| Clearance of Imports at Ports of Entry | 2days | |
| Verification of imports (un-registered drugs) | 10days | |
| Regulatory decision on drug promotional materials | 10days | |
| Publication of the database of approved promotional materials/advert | Monthly(5th of the month) |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Pharmacovigilance | Acknowledgement of receipt of an ADE report (email/letter) | 5days |
| Feedback on serious ADE reports | 18days | |
| Feedback on serious AEFI reports to the Expanded Program for Immunization (EPI) | 14days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Laboratory testing | Test results from mandatory testing after sampling (Medicine)-PoE. | 48days |
| Test results from mandatory testing after sampling (Medical Devices). | 25days | |
| Test results from client requests after acceptance by the lab (All Products). | 45days | |
| Test results for pre-market samples (Domestic Manufacturers). | 60days | |
| Test results for Public Health Products (LLINs, Face Masks, Hand Sanitizers and other) samples. | 45days | |
| Test results for post-market surveillance (Medicines). | 48days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| National Regulatory System | Issuance of recall or alert for a substandard or falsified medicine or health care product | 14days |
| Acknowledgement of receipt of a product complaint | 5days | |
| Feedback on a market (process, product, other) complaint | 20days | |
| Feedback on the effectiveness of recall after receipt of the recall report from the LTR (Local Technical Representative) | 10days | |
| Feedback on test results from the Lab to the client | 5days | |
| Support to Regulatory areas | QUALITY MANAGEMENT SYSTEM | |
| Acknowledgement of receipt of a service - related complaint | 2days | |
| Feedback on service - related complaints | 21days |
Notes
- All days stated are working days
- All timelines are counted from day zero which is the date the application, service request or notification at NDA. For electronic submissions it is assumed that the date submitted is the date received
- When a request is made to an applicant or client for additional information or clarification, the NDA clock stops until the client’s response is received. The timelines presented therefore only represent the total time NDA has to undertake a particular action.
NDA MANAGEMENT
