REGULATORY AREA

ACTION

TIMELINE

Clinical Trial (CT) Oversight

Screening & acknowledgement of a Clinical Trial Application
Regulatory decision on a CTA
Annual renewal of ongoing trials
Amendment of CT Authorisation

10days
n
60days

20days

20days

Veterinary Field Trial Oversight

Acknowledgement of receipt of a field trial application (FTA)
Feedback on screening of a FTA
Regulatory decision on a FTA
n

Acknowledgement of receipt of a Marketing Authorisation (MA) application
Feedback on screening of MA application for completeness

n

5days
n
10days
50days
n

5days
n
10days

Marketing Authorisation (MA)

General considerations

n

Assessment of application and request for additional information on application for MA (Human drugs)
Assessment of application and request for additional information on application for MA (Veterinary drugs)
Assessment of application and request for additional information on application for MA(Vaccines, Anti-cancer medicines, other vital medicines)
Assessment of application and request for additional information on application for MA(herbal medicines – imported)
Regulatory Decision on MA after additional information is received

n

General

n

250days
n
120days
n
120days
n
n
120days
n
n
90days

Special categories

n

Regulatory Decision on MA for domestically manufactured products (herbal, conventional)
Regulatory decision on MA for WHO Prequalified products
Regulatory Decision on products already authorized for marketing by Stringent
Regulatory Authorities and those approved under article 58 of EU regulations.

n

Special

n

90days
n
90days
n
120days

Variation & Notification

n
Regulatory decision on minor variation
Regulatory decision on major variation (if the application does not require physical verification)
Regulatory decision on Annual or immediate notification of change

n

Variation

n
90days
120days
n
60days

Drug Register

n
Publication of the drug register
n

Register

n
Monthly(5th of the month)
n

n

Regulatory Inspection

n
Physical inspection after receipt of application – Foreign
Physical inspection after receipt of application – Domestic
Feedback on GMP desk audit after receipt of application
Feedback after inspection – Foreign
Feedback after inspection – Domestic
Regulatory Decision after CAPA – Foreign
Regulatory Decision after CAPA – Domestic
n

n
180days
n
20days
n
60days
n
20days
10days
20days
10days

n

Premise Licensing

n
Physical inspection after receipt of application – New outlet
Physical inspection after receipt of application – Renewal
Regulatory decision after inspection – New and Renewal
Publication of the list of licensed outlets
n

n
15days
n
40days
n
10days
n
Monthly(5th of the month)

n

Market Surveillance and Control

n
Verification of imports (Registered drugs)
Verification of imports (un-registered drugs)
Acknowledgement of receipt of an application for authorization of a drug advert/promotional material
Regulatory decision on drug promotional materials
Publication of the database of approved promotional materials/advert
n

n
3 days
10 days
2 days
n
15 days
Monthly(5th of the month)

n

Vigilance

n
Acknowledgement of receipt of an ADE report (email/letter)
Feedback on an ADE report
n

n
2days
n
20days

n

Laboratory testing

n
Test results from mandatory testing after sampling (medicines)
Test results from mandatory testing after sampling (medical devices)
Test results from client request after acceptance by the lab (all products)
Test results for pre market samples (Domestic Manufacturers)
n

n
20days
n
30 days
n
30 days
n
60 days

n

National Regulatory System

n
Issuance of recall or alert for a substandard or falsified medicine or health care product
Acknowledgement of receipt of a product complaint
Feedback on a market (process, product, other) complaint
Supervision of destruction of unwanted medical products after application
Response to general letters/inquiries (email, print)
Supplier and vendor payments
n

n
5 days
n
2 days
20 days
n
7 days
n
3 days
7 days

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