The Electronic Common Technical Document (eCTD) is an interface developed by the International Conference on Harmonisation (ICH) to enable the exchange of regulatory data and information from pharmaceutical industries to regulatory agencies. The content is based on the Common Technical Document (CTD) format and follows an eCTD specification (found on the following site: http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf -the latest updates/notices relating to the eCTD specifications are available on the FDA website).
The CTD holds information in the form of modules, sections and documents regarding the quality, safety and efficacy of new pharmaceuticals. This format is used in a marketing authorisation application for human use in European Union, Japan and United States (regions that are party to the ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). The CTD defines the content of the common modules (modules 2-5), whereas the contents of the regional module 1 are defined by each of the ICH regions.
ISO Identification of Medicinal Products (IDMP) legislation
The ISO Identification of Medicinal Products (IDMP) standard, mandated by the European Medicines Agency (EMA) effective on 1 July 2016, poses a significant compliance challenge for the pharmaceutical industry. The main aim of IDMP is to define a universal ID for a medicinal product that can be cross-referenced in Individual Case Safety Reports (ICSRs) and support product reconciliation across the entire product supply-chain.
GCC-DR structure, registration process and points to consider when choosing this route to registration
The Gulf Central Committee for Drug Registration (GCC-DR) was formed in May 1999 with six Middle Eastern States – Saudi Arabia, Kuwait, Qatar, Bahrain, Oman and the United Arab Emirates; and in 2003 Yemen became the seventh member of the GCC-DR. The aim of the GCC-DR is to work together to review/approve pharmaceutical companies and their drugs by means of a centralised registration procedure in order to provide the seven member states with safe and effective medicines with a reasonable price. Included in the structure of the GCC-DR is a permanent Secretariat with responsibilities including the receiving/reviewing of registration files for completeness, 2 members nominated from each State regulatory authority (collectively called the “Steering committee”) with duties including company/product registration and guideline approval, a general director, an executive board, and at the highest level the Council of Ministers of Health (CMH). The CMH consists of health ministers from each of the seven member States and overseas approval of all guidelines and policies adopted by the Steering committee.