COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL
Journal Title: International Journal of Drug Regulatory Affairs - Year 2016, Vol 4, Issue 2
Abstract
This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA and Brazil. Based on the information collected from various sources such as regulatory sites, Government websites, discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, a clear picture on the generic drug approval and registration process of each country was drawn. The different authorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) of USA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval and registration process in the respective countries. After analysing the various requirements for the generic drug approval in the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not well defined. But FDA gives very much well defined requirements.
Authors and Affiliations
Joseph Lincy, George Mathew, Malaviya Kalpesh K, Chacko Bincy K, Badjatya Jitendra Kumar
Keywords
Related Articles
- EP ID EP338031
- DOI -
- Views 84
- 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...
REVIEW OF MARKETING AUTHORIZATION OF MEDICAL DEVICES IN INDIA
Marketing authorization of medical devices in India is given under heading “Registration Certificate and it is as per the regulatory processes in other countries. The foreign companies marketing of medical devices requir...
Informed Consent form in Clinical Trial
Informed consent form is a vital requirement for research study on the human participant. It is the consent which is given by the subject before participate in clinical trial. Informed consent mainly came in existence af...
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...
Integrating PLCM strategy in Pharmaceutical Emerging Market
All products and services must denote definite life cycles. The life cycle talks about the period from the product‘s first launch till it wind-up onto the market. Throughout this age noteworthy modifications are made in...