Development & Filing of Orphan/ Generic Drugs & APIs: Regulative Needs. A Comparative Study on Regulatory Needs for the Development & Filing of Orphan/ Generic Drugs & APIs in Selected Country

      Аннотация: The medicament allowance in the US, Europe & India are of utmost importance in the world. The goal of the laws governing medicinal articles in US, Europe & India is to protect citizens’ fitness and provide with the improvised quality of life.The primary motive of this study wasthe comparative investigation of development and filing process of Orphan Drugs, Generic Drugs and APIsin US, Europe & India.Results of comparative analysis of generic drug filing haveshowed that nine out of the ten jurisdictions had mandated drug approval timelines. A comparative study on the regulatory review process across 3 regulatory agencies in the USA, Europe & India reported overall approval time range across these jurisdictions, which ranged from 368 to 595 days including client times.The orphan drug regulation in US and EU has been successful in providing treatments to the patients with rare diseases. US have the great role in evolution of rare medicament and infrequent disorder. Its Orphan Drugs Act of 1983 has showed radical path in the area of medicament.

Ключевые слова: orphan, Generic, APIs, Drugs, development, Filing, Regulatory, Requirements