A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 2
Abstract
Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. USFDA has specified three major drug development tools and has also given the guidelines recommending their qualification which would expedite the drug development process. This qualification would ensure better understanding of drug targets and long term safety outcomes. Regulatory authorities of Europe, Japan & India have also focused on developing a formal qualification process of drug development tools though most of it follows USFDA.
Authors and Affiliations
Garima Kshatriya, Dilip G. Maheshwari
Keywords
Related Articles
- EP ID EP329285
- DOI 10.22270/ijdra.v6i2.227
- Views 85
- Downloads 0
PATENT V/S MONOPOLY-A CASE STUDY
Provisions of Compulsory License balance this law between interest of Inventor & public as through these provisions License can be provided to others if the invention did not use sufficiently for Public. In case of medic...
A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA
The present study reviews the regulations of herbal drugs in the EU, US and India and throws light upon issues related to their clinical trials. Herbal drugs have been used for a long time in different systems of health...
Regulatory overview of biosimilars in Europe
A biosimilar is a biological medicine similar, but not identical, to an already registered reference bio therapeutic product in terms of quality, safety, and efficacy. These drugs are also called as biosimilar products„,...
INDONESIAN PATENT SYSTEM: AN OVERVIEW
Intellectual property protection is a one type of protection to the innovator from their creative efforts. On November 1, 1991, the Indonesian Parliament passed Law No. 6/1989 on Patents. The new law came into effect on...
REGULATIONS OF ORPHAN DRUGS IN USA, EU AND INDIA-A COMPARATIVE STUDY
Orphan drugs are the drugs and natural products used in treatment, diagnosis, or prevention of rare disease. The orphan drug regulation varies in different countries. Initially a guideline (Orphan Drug Act) for orphan dr...