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Service Delivery Timelines



 



REGULATORY 
AREA   
 

 
ACTION                                                                                  


TIMELINE     

 


 

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

 
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



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