While the name of the standard – Electronic Common Technical Document(eCTD)–is always the same, there are regional differences in its requirements. Each region of the world asks for its own adaptations. We looked closer at the differences between the geographical areas regarding eCTD submissions.
Initially, the eCTD was established to create a common standard that facilitates submissions for the life sciences industry for eCTD Module 2 to Module 5 and also agreed to have a regional part in Module 1. The different regions of the world, however, have yet to be able to agree on an utterly identical standard also in M2 to M5 when it comes to eCTD submissions. As a result, depending on the continent or even the country, the forms of presentation of the required information by the agencies differ, sometimes considerably. To successfully bring their products to market in time, pharmaceutical companies depend on knowing the differences and being able to respond appropriately.
We have compiled a little overview of the most critical differences regarding eCTD submissions in the different regions of the world:
United States: The US Food and Drug Administration (FDA) requires electronic submissions in the form of electronic common technical documents (eCTD) for new drug applications, abbreviated new drug applications, biologic license applications, and certain other submission types. The eCTD format for FDA includes already an application form within the administrative envelope part. In Module 4 and 5 there are specific formats for study data required, so-called Study Tagging Files (STF).
European Union: The European Medicines Agency (EMA) also asks for electronic submissions in the eCTD format. Specific requirements do differ, though, from those in the US. For example, submissions in the EU must include different specific country sections in Module 1 and detailed specific sections for the product information.
Japan: Electronic submissions in the eCTD format are also mandatory for submissions in Japan. There are unique requirements for certain submission types required by the Pharmaceuticals and Medical Devices Agency (PMDA). For example, the lifecycle of a dossier is only containing one regulatory activity and starts newly with the next regulatory activity. As a second example, the drug master file must be submitted in a format called the Common Technical Document for Drug Master Files (CTD-DMF).
Canada: For submissions in Canada, you must use the eCTD format, but Health Canada asks for slightly different information regarding specific requirements. All electronic submissions have to be accompanied by a signed attestation form, for example.
China: The China National Medical Products Administration (NMPA) also accepts eCTD submissions for Investigational New Drugs applications (IND) and New Drug Applications (NDA). NMPA requests documents in the Chinese language also for M2-M5 as legally binding. English documents can be added as second documents in the sections.
These are just a few examples of the regional differences in electronic submission requirements for the pharmaceutical industry. With new developments within society and jurisdiction, they change over time and may also vary depending on the specific submission type and other factors. Therefore, the best way to be sure that you are fulfilling the current requirements of the national authorities is to consult a regulatory affairs specialist.