Frequently Asked Question

6. How long will it take for my medicines to be registered?

The amount of time it takes for a medicine to be approved depends of many factors. It depends on whether the submission contains all the required information as stipulated in the CTD registration guideline. Lastly, evaluation of medicines involves cycles which involve communication with applicants regarding further submission of additional information or documentation. In this respect, it is dependent on how the applicant quickly responds and provides complete responses to queries raised. The median time it took for a product application to be approved in 2016 was 20 months (including MCAZ and applicant’s time), however the actual time is product specific.