Regulatory Dossiers
Until recently, for each country or region, the information generated during drug development (i.e. study results, details of manufacture and legal/admin info) had to be documented in so-called regulatory dossier. This dossier was to be organized in accordance with country-specific national requirements and submitted for review by National Health Authorities.

Fortunately, Health Authority representatives of the US, EU and Japan, together with representatives from the pharmaceutical trade associations form these regions founded the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, abbreviated ICH. This is a unique project that was established in 1990, with aims to produce a single set of technical requirements for the registration of new drug products, hence to streamlining the development process.

One of the major achievements of the ICH has been the development of the common technical document (CTD), a standard structure for the dossier used when applying for marketing approval of a pharmaceutical product in the EU, the US and Japan. More recently, further harmonization led to the development of exchange standards for an electronic CTD (eCTD).
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