What is CTD Dossier?
The Common Technical Document (CTD), developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labor and Welfare (Japan) and maintained by the International Conference on Harmonization (ICH),is an arrangement for submission record for the registration of drugs and medicines. It is created and designed so that it may be used in the United States, Japan and across Europe. The CTD is a globally approved system for the groundwork of applications concerning new medicines and drugs that are to be presented to regional regulatory establishment in countries who are its participants.
The Common Technical Document (CTD) is categorized into five components:
- Managerial and prescribing info
- Summary and synopsis of medical reports, nonmedical reports, and quality
- Quality and worth (pharmaceutical certification)
- Premedical stage/ preclinical (Pharmacology/Toxicology)
- Clinical / medical / scientific – efficacy (Clinical Trials)
Comprehensive explanation and subheads for every component are different, particular and specific for all jurisdictions. Regional administration and managerial information and some other subheads of other components varies, based on national requirements. Apart from Japan, the United States of America and other European counties (European Union), the Common Technical Document (CTD) has been accepted by many other countries like Switzerland and Canada.
The CTD has transformed the rigid review procedure, led to synchronized and coordinated electronic submission that allows execution of high-quality review practices. It has purged the call for reformatting the info for submission to the ICH. The Paper CTD is ordained to be substituted by its electronic complementary part, the Electronic Common Technical Document (eCTD).
Guidelines on Common Technical Document (CTD), created by CDSCO is based on:
The ICH Harmonized principle on “Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use”. Drugs & Cosmetics Act 1940 and regulations are made here under.