Chiara Innocenti -

The new registration of medicinal products in countries not belonging to ICH (International Conference on Harmonization) Regions is a challenging task since their regulations are not harmonized.

These countries include mainly the following macro-areas: Asian countries, African countries, Middle East countries, Latin America and Commonwealth of Independent States (CIS).

The principal regulatory documents usually needed in order to obtain marketing authorization in countries not belonging to ICH Regions are:

  • Application Dossier which includes the Chemistry, Manufacturing and Control Documents relevant to Active Pharmaceutical Ingredient (API), Finished Drug Product, pharmacological, toxicological and clinical data;
  • Artworks of Package Leaflet, box and labels;
  • Administrative documents, such as Certificates of Pharmaceutical Product (CPP), WHO-GMP certificates;
  • Other relevant documents are registration fees, samples, prices declarations in comparison with other countries of interest for the applicant.

Anyway, each country has its own local requirements and this leads to the necessity to obtain information from different countries and establish a proper network for a company which intends to market a medicinal product in certain regions.

For this reason, huge experience is needed to manage the registration processes in non-ICH regions for the identification of the suitable documents to be submitted to the Authorities on the basis of the specific local requirements and for the coordination of several procedures where different requirements often have to be managed in parallel.

RPN has an established network and a wide experience in registering products in non-ICH countries.

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