Multi-region submissions & submission standards

Multi-region submissions & submission standards refer to the process of submitting regulatory documentation for the approval of a product in multiple countries or regions. In order to achieve approval in multiple regions, the product must meet the regulatory requirements of each region.

To facilitate multi-region submissions, there are various international standards and guidelines that have been developed to harmonize the regulatory process. For example, the Common Technical Document (CTD) format is used as a standardized format for submitting regulatory documentation in the European Union (EU) and other regions such as Japan.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is another example of an organization that develops standards to harmonize the regulatory process. ICH provides guidelines for the development, registration, and post-approval of pharmaceuticals, and its guidelines are widely adopted by regulatory authorities around the world.

In addition to these international standards, each region may have its own specific requirements for regulatory submissions. For example, the US Food and Drug Administration (FDA) has its own specific requirements for the submission of new drug applications (NDAs).

In summary, multi-region submissions & submission standards can be facilitated by the use of international standards and guidelines, such as the CTD format and ICH guidelines. However, it is important to also consider the specific requirements of each region in order to ensure compliance with all relevant regulations.

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