Clinical Trial (CT) Oversight
|
Acknowledgement of receipt of a Clinical Trial Application (CTA)
|
5 days
|
Feedback on screening of a CTA
|
10 days
|
Regulatory decision on a CTA
|
70 days
|
Annual renewal of ongoing trials
|
20 days
|
Amendment of CT Authorisation - minor
|
10 days
|
Amendment of CT Authorisation - major
|
20 days
|
|
Veterinary Field Trial Oversight
|
Acknowledgement of receipt of a field trial application (FTA)
|
5 days
|
Feedback on screening of a FTA
|
10 days
|
Regulatory decision on a FTA
|
50 days
|
|
Marketing Authorisation (MA)
|
Acknowledgement of receipt of a Marketing Authorisation (MA) application
|
5 days
|
Feedback on screening of MA application for completeness
|
10 days
|
GENERAL CONSIDERATIONS
| |
Assessment of application and request for additional information on application for MA
(Human drugs)
|
250 days
|
Assessment of application and request for additional information on application for MA
(Veterinary drugs)
|
120 days
|
Assessment of application and request for additional information on application for MA
(Vaccines, Anti-cancer medicines, other vital medicines)
|
120 days
|
Assessment of application and request for additional information on application for MA
(herbal medicines - imported)
|
120 days
|
Regulatory Decision on MA after additional information is received
|
90 days
|
SPECIAL CATEGORIES
| |
Regulatory Decision on MA for domestically manufactured products
(herbal, conventional)
|
90 days
|
Regulatory decision on MA for WHO Prequalified products
|
90 days
|
Regulatory Decision on products already authorized for marketing by Stringent
Regulatory Authorities and those approved under article 58 of EU regulations.
|
120 days
|
VARIATION AND NOTIFICATION
| |
Regulatory decision on minor variation
|
90 days
|
Regulatory decision on major variation (if the application does not require physical
verification)
|
120 days
|
Regulatory decision on Annual or immediate notification of change
|
60 days
|
DRUG REGISTER
| |
Publication of the drug register
|
Monthly
(5th of the
month)
|
|
Regulatory Inspection
|
Physical inspection after receipt of application - Foreign
|
180 days
|
Physical inspection after receipt of application - Domestic
|
20 days
|
Feedback on GMP desk audit after receipt of application
|
60 days
|
Feedback after inspection - Foreign
|
20 days
|
Feedback after inspection - Domestic
|
10 days
|
Regulatory Decision after CAPA - Foreign
|
20 days
|
Regulatory Decision after CAPA - Domestic
|
10 days
|
|
Premises Licensing
|
Physical inspection after receipt of application - New outlet
|
15 days
|
Physical inspection after receipt of application - Renewal
|
40 days
|
Regulatory decision after inspection - New and Renewal
|
10 days
|
Publication of the list of licensed outlets
|
Monthly
(5th of the
month)
|
|
Market Surveillance and Control
|
Verification of imports (Registered drugs)
|
3 days
|
Verification of imports (un-registered drugs)
|
10 days
|
Acknowledgement of receipt of an application for authorization of a drug
advert/promotional material
|
2 days
|
Regulatory decision on drug promotional materials
|
15 days
|
Publication of the database of approved promotional materials/advert
|
Monthly
(5th of the
month)
|
|
Vigilance
|
Acknowledgement of receipt of an ADE report (email/letter)
|
2 days
|
Feedback on an ADE report
|
20 days
|
|
Laboratory Testing
|
Test results from mandatory testing after sampling (medicines)
|
20days
|
Test results from mandatory testing after sampling (medical devices)
|
30 days
|
Test results from client request after acceptance by the lab (all products)
|
30 days
|
Test results for pre market samples (Domestic Manufacturers)
|
60 days
|
|
National Regulatory System
|
Issuance of recall or alert for a substandard or falsified medicine or health care product
|
5 days
|
Acknowledgement of receipt of a product complaint
|
2 days
|
Feedback on a market (process, product, other) complaint
|
20 days
|
Supervision of destruction of unwanted medical products after application
|
7 days
|
Response to general letters/inquiries (email, print)
|
3 days
|
Supplier and vendor payments
|
7 days
|
|
