| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Clinical Trial (CT) Oversight | Screening & acknowledgement of a Clinical Trial Application | 10days |
| Regulatory decision on a CTA | 60days | |
| Annual renewal of ongoing trials | 20days | |
| Amendment of CT Authorisation | 20days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Veterinary Field Trial Oversight | Acknowledgement of receipt of a field trial application (FTA) | 5days |
| Feedback on screening of a FTA | 10days | |
| Regulatory decision on a FTA | 50days | |
| Acknowledgement of receipt of a Marketing Authorisation (MA) application | 5days | |
| Feedback on screening of MA application for completeness | 10days |
| 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 MA for WHO Prequalified products | 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 Months (66 Days) | |
| DRUG REGISTER | ||
| Publication of drug register | Monthly (5th working day of the month) |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Regulatory Inspection | Physical inspection after receipt of application – Foreign | 180days |
| Physical inspection after receipt of application – Domestic | 20days | |
| Feedback on GMP desk audit after receipt of application | 60days | |
| Feedback after inspection – Foreign | 20days | |
| Feedback after inspection – Domestic | 10days | |
| Regulatory Decision after CAPA – Foreign | 20days | |
| Regulatory Decision after CAPA – Domestic | 10days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Premise Licensing | Physical inspection after receipt of application – New outlet | 15days |
| Physical inspection after receipt of application – Renewal | 40days | |
| Regulatory decision after inspection – New and Renewal | 10days | |
| Publication of the list of licensed outlets | Monthly(5th of the month) |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Market Surveillance and Control | Verification of imports (Registered drugs) | 3days |
| Verification of imports (un-registered drugs) | 10days | |
| Acknowledgement of receipt of an application for authorization of a drug advert/promotional material | 2days | |
| Regulatory decision on drug promotional materials | 15days | |
| Publication of the database of approved promotional materials/advert | Monthly(5th of the month) |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Vigilance | Acknowledgement of receipt of an ADE report (email/letter) | 2days |
| Feedback on an ADE report | 20days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| Laboratory testing | Test results from mandatory testing after sampling (medicines) | 20days |
| Test results from mandatory testing after sampling (medical devices) | 30days | |
| Test results from client request after acceptance by the lab (all products) | 30days | |
| Test results for pre market samples (Domestic Manufacturers) | 60days |
| REGULATORY AREA | ACTION | TIMELINE |
|---|---|---|
| National Regulatory System | Issuance of recall or alert for a substandard or falsified medicine or health care product | 5days |
| Acknowledgement of receipt of a product complaint | 2days | |
| Feedback on a market (process, product, other) complaint | 20days | |
| Supervision of destruction of unwanted medical products after application | 7days | |
| Response to general letters/inquiries (email, print) | 3days | |
| Supplier and vendor payments | 7days |
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
