Regulatory pathway for generic and new drug registration in China and Russia

Abstract

Objectives: The objective of present work is to understand the regulatory requirements and registration process
of generic and new drugs in China and Russia. Methods: The dossier for the generic and new drugs should be
submitted in electronic common technical document (eCTD) format to both the countries China and Russia, since
both countries follow the same format of eCTD. All the modules of CTD are almost same for both the countries
except module 1. Module 1 differs from country to country. Results: In China, drug marketing authorization
applications, drug clinical trial application drug registration applications and supplemental applications which are
required for manufactured products that are reviewed by the Drug Evaluation Center of National medical products
administration (NMPA). In Russia, the National Centre of Pharmaceutical products (FGU) oversee the quality,
effectiveness, and protection of all the generic and new drug products. Conclusion: From the current study, it was
concluded the regulatory authorities of both China and Russia have almost the similar regulatory documents and
requirements for the approval of generic and new drugs. The major difference is found in the language submission
of dossiers. Roszdravnadzor allows Russian language while NMPA allows submission by using standard Chinese
language in China. The safety, efficacy, quality of the drug products is the main objective of both authorities.