Overview of Challenges Involved in Regulatory Filing an Approval Process

The United States, Europe and Japan are a part of International Conference on Harmonization (ICH), hence, the technical requirements for registration of Pharmaceuticals follow the ICH recommendations. These countries require data as per the requirements of Common Technical Document (CTD). The CTD is organised into five modules. Module 1 is region specific and modules 2, 3, 4 and 5 are intended to be common for all regions. Rest of the region/countries insists on following ICH region for some data like stability, clinical trials, though it follows chiefly its own regulations. For instance, the ASEAN countries require data as per ASEAN CTD (ACTD), which is same as ICH CTD for data requirements organised in parts.