Department of Pharmaceutical Chemistry & Quality Assurance, School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.
School of Pharmacy, Rai University, Saroda, Dholka Road, Ahmedabad, Gujarat, INDIA-382260.
Zhongguo Ying Yong Sheng Li Xue Za Zhi. 2024 Oct 10;40:e20240029. doi: 10.62958/j.cjap.2024.029.
The Abbreviated New Drug Application (ANDA) is used for the regulatory submission of generic drugs, which are pharmaceutical equivalents to brand-name drugs and distributed without patent protection. Different countries have their own regulatory requirements for the approval of generic drugs, enforced by authorities such as the CDSCO in India, EDQM in Europe, and USFDA in the United States. This review aims to compare the regulatory processes and requirements for generic drug approval in India, Europe, and the US, highlighting key differences and challenges. The involvement of regulatory authorities in the drug development process is crucial for expediting approval and addressing queries, helping to minimize delays. The Common Technical Document (CTD) format is employed across regions to harmonize submission requirements. This study underscores the differences in dossier submission for generics across the three regions, illustrating India's position in the global generic drug approval landscape. By comparing approval requirements, this work provides insight into the hurdles India must overcome to streamline its approval process. The ANDA allows generic manufacturers to submit bioequivalence studies, using the original innovator's safety and efficacy data. However, obtaining approval simultaneously from multiple regulatory authorities remains a challenging task. Careful review of regulatory documents by skilled personnel can reduce regulatory queries, ultimately accelerating the market launch of generic drugs. This review provides a comprehensive overview of the generic drug approval process, emphasizing the need for harmonization and improved efficiency in India's regulatory framework.
简略新药申请（ANDA）用于仿制药的监管申报，仿制药是与品牌药具有相同疗效的药物，且不受专利保护。不同国家对仿制药的批准有其各自的监管要求，这些要求由印度的 CDSCO、欧洲的 EDQM 和美国的 USFDA 等机构执行。本综述旨在比较印度、欧洲和美国的仿制药批准的监管流程和要求，突出关键差异和挑战。监管机构参与药物开发过程对于加快批准和解决查询至关重要，有助于最大程度地减少延迟。通用技术文件（CTD）格式在各地区被采用，以协调提交要求。本研究强调了这三个地区仿制药提交文件的差异，展示了印度在全球仿制药批准中的地位。通过比较批准要求，这项工作深入了解了印度必须克服的障碍，以简化其批准流程。ANDA 允许仿制药制造商提交生物等效性研究，使用原始创新者的安全性和疗效数据。然而，同时获得多个监管机构的批准仍然是一项具有挑战性的任务。由熟练人员仔细审查监管文件可以减少监管查询，最终加速仿制药的市场推出。本综述全面概述了仿制药的批准流程，强调了印度监管框架需要协调和提高效率。
