TY - JOUR AU - Sandeep, Dr. D. S. PY - 2023/03/15 Y2 - 2024/03/28 TI - Regulatory pathway for generic and new drug registration in China and Russia JF - Asian Journal of Pharmaceutics (AJP) JA - AJP VL - 17 IS - 1 SE - REVIEW ARTICLES DO - 10.22377/ajp.v17i1.4703 UR - https://asiapharmaceutics.info/index.php/ajp/article/view/4703 SP - AB - <p>Objectives: The objective of present work is to understand the regulatory requirements and registration process<br>of generic and new drugs in China and Russia. Methods: The dossier for the generic and new drugs should be<br>submitted in electronic common technical document (eCTD) format to both the countries China and Russia, since<br>both countries follow the same format of eCTD. All the modules of CTD are almost same for both the countries<br>except module 1. Module 1 differs from country to country. Results: In China, drug marketing authorization<br>applications, drug clinical trial application drug registration applications and supplemental applications which are<br>required for manufactured products that are reviewed by the Drug Evaluation Center of National medical products<br>administration (NMPA). In Russia, the National Centre of Pharmaceutical products (FGU) oversee the quality,<br>effectiveness, and protection of all the generic and new drug products. Conclusion: From the current study, it was<br>concluded the regulatory authorities of both China and Russia have almost the similar regulatory documents and<br>requirements for the approval of generic and new drugs. The major difference is found in the language submission<br>of dossiers. Roszdravnadzor allows Russian language while NMPA allows submission by using standard Chinese<br>language in China. The safety, efficacy, quality of the drug products is the main objective of both authorities.</p> ER -