When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered. Regulating complementary medicines in South Africa post June 2016 requires dossier submissions in ZA CTD (South Africa Common Technical Document) format. It’s been a year we’ve written on proposed mandate for converting Common Technical Document (CTD) to (ZA CTD). As the deadline is passed by, from now on the Regulatory professionals must consider re-aligning their South African dossier submission activities with that of the ZA CTD format.
The format bears a significant resemblance to that of ICH CTD and also stands identical to Medicines Registration Form (MRF1). Apart from being time consuming in conversion process, the ZA CTD demands diligent approach from Regulatory professionals involving five modules and many numbered subsections.
Module 1: Administrative Information
Module 2: Common Technical Document Summaries
Module 3: Quality
Module 4: Non-clinical Study Reports
Module 5: Clinical Study Reports
Aimed at harmonization of dossier content, the ZA CTD submission might seem a challenging aspect for companies. Freyr is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate. For some of these global companies, CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.