| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Clinical Trial Oversight (CTO) | Receipt, screening, and acknowledgment of the initial Clinical Trial Application | 10days | DPS-Clinical Trials Unit |
| Regulatory decision on a Clinical Trial Application | 50days | DPS-Clinical Trials Unit | |
| Annual renewal of ongoing trials | 20days | DPS-Clinical Trials Unit | |
| Amendment of CT Authorisation | 20days | DPS-Clinical Trials Unit | |
| Feedback report to a client following a GCP Inspection | 45days | DPS-Clinical Trials Unit |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Veterinary Field Trial Oversight and Pharmacovigilance (VFTOP) | Acknowledgement of receipt of a field trial application (FTA) | 10days | Directorate of Veterinary Services |
| Regulatory decision on an FTA | 50days | Directorate of Veterinary Services | |
| Feedback report to a client following a GCP Inspection of field trials | 45days | Directorate of Veterinary Services | |
| Acknowledgement of receipt of safety report | 5days | Directorate of Veterinary Services | |
| Feedback on causality assessment | 30days | Directorate of Veterinary Services | |
| Feedback following evaluation of the end of the field trial report | 25days | Directorate of Veterinary Services |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Marketing Authorization (MA) | GENERAL CONSIDERATION | ||
| Assessment of application and request for additional information on application for MA (Human Drugs) | 18 months (396 Days) | DPAR-Medicines Unit | |
| Assessment of application and request for additional information on application for MA (Veterinary Drugs) | 14 months (308 Days) | DPAR-Medicines Unit | |
| Assessment of application and request for additional information on application for MA (Vaccines) | 6 Months (132 Days) | DPAR-Medicines Unit | |
| Regulatory decision on MA after additional information is received | 3 Months (66 Days) | DPAR-Medicines Unit | |
| SPECIAL CATEGORIES | |||
| Regulatory decision on MA for domestically manufactured Conventional Medicines | 6 Months (132 Days) | DPAR-Medicines Unit | |
| Regulatory decision on products already authorized for marketing by Stringent Regulatory Authorities, WHO Prequalified products and those approved under Article 58 of EU regulations | 6 Months (132 Days) | DPAR-Medicines Unit | |
| Medical products and technologies granted MA within 66 working days (90 calender days) at both continental and regional level. | 3 Months (66 Days) | DPAR-Medicines Unit | |
| VARIATION AND NOTIFICATION | |||
| Regulatory decision on minor variation | 4 Months (88 Days) | DPAR-Medicines Unit | |
| Regulatory decision on Major variation (if the application does not require physical verification) | 6 Months (132 Days) | DPAR-Medicines Unit | |
| DRUG REGISTER | |||
| Publication of drug register | Monthly (5th working day of the month) | DPAR-Medicines Unit |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Regulatory Inspection (RI) | GMP Physical inspection after receipt of application – Foreign | 180days | DIE-GMP Unit |
| GMP Report feedback to manufacturer after Inspection | 45days | DIE-GMP Unit | |
| Feedback after inspection – Domestic | 28days | DIE-GMP Unit | |
| Regulatory Decision after CAPA – Foreign | 20days | DIE-GMP Unit | |
| Regulatory Decision after CAPA – Domestic (Local facilities) | 17days | DIE-GMP Unit |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Premise Licensing (PL) | Feedback to an applicant on the regulatory decision for pharmacy renewal | 40days | DIE-Licensing |
| Feedback to the applicant on the Regulatory decision for licensing of new Pharmacy applicants | 30days | DIE-Licensing |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Market Surveillance and Control (MSC) | Verification of imports (Registered drugs) | 3days | DIE-Imports and Exports Unit |
| Clearance of Imports at Ports of Entry | 2days | DIE-Imports and Exports Unit | |
| Regulatory decision on drug promotional materials | 10days | DPS-Drug Promotions Unit | |
| Publication of advert of approved promotional materials/advert | Monthly (5th of the following month) | DPS-Drug Promotions Unit |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Vigilance (PV) | Acknowledgement of receipt of an ADE | 5days | DPS-Pharmacovigillance Unit |
| Feedback on serious ADE reports | 18days | DPS-Pharmacovigillance Unit | |
| Feedback on serious AEFI reports to the Expanded Program for Immunization (EPI) | 14days | DPS-Pharmacovigillance Unit |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| Laboratory testing (LT) | Test results from mandatory testing after sampling (Medicine)-PoE. | 48days | DLS-Medicnes Unit |
| Test results from mandatory testing after sampling (Medical Devices). | 25days | DLS-Medical Devices Unit | |
| Test results from client requests after acceptance by the lab (All Products). | 45days | DLS-Medicines and Medical Devices Unit | |
| Test results for pre-market samples (Domestic Manufacturers). | 60days | DLS-Medicnes Unit | |
| Test results for post-market surveillance (Medicines). | 48days | DLS-Medicnes Unit | |
| Test results for post-market surveillance (Medical Devices) | 30days | DLS-Medical Devices Unit |
| REGULATORY AREA | SERVICE | MINIMUM ACCESS TIME (WORKING DAYS) | SERVICE DELIVERY POINT |
|---|---|---|---|
| National Regulatory System (NRS) | Issuance of recall or alert for a substandard or falsified medicine or health care product | 8days | DIE-PMS Unit |
| Acknowledgement of receipt of a product complaint | 3days | DIE-PMS Unit | |
| Feedback on a market (process, product or other) complaint | 20days | DIE-PMS Unit | |
| Feedback on the effectiveness of recall after receipt of the recall report from the LTR (Local Technical Representative) | 15days | DIE-PMS Unit | |
| Feedback on test results from the Lab to the client | 5days | DIE-PMS Unit | |
| QUALITY MANAGEMENT SYSTEM | |||
| Acknowledgement of receipt of a service - related complaint | 2days | SA-QMS Department | |
| Feedback on service - related complaints | 21days | SA-QMS Department |
Notes
- All days stated are working days
- All timelines are counted from day zero, which is the date of the application, service request, or notification at NDA. For electronic submissions, it is assumed that the date submitted is the date received
- When the National Drug Authority (NDA) requests additional information or clarification from an applicant or client, the processing clock is paused until a response is received. Once the required information is submitted, the clock resumes. As such, the timelines indicated reflect only the duration within which NDA is responsible for executing a given regulatory action
NDA MANAGEMENT
