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Biotechnology research continually opens opportunities for the development of new biopharmaceuticals for human use.
Consequently, integration of public healthcare and human welfare with the business of biotechnology is becoming a central
challenge. However, the companies developing such products are often small and they may have insufficient knowledge of the
possible regulatory aspects concerning such new products. Like major pharmaceutical firms, today's biotechnology companies
must leverage their development programs internationally and penetrate global markets to remain competitive.
To maximize market penetration, most biologics developers are targeting the largest international markets for new medicines
-the U.S. & European Union. Within these two "prize" markets, fundamental regulatory changes affecting biotechnology product
regulation have been implemented recently.
The United States and the European Union share a common desire to provide a safe food supply and credible regulatory
systems. However, they have adopted two very different regulatory approaches to deal with the increasing numbers of GM
(genetically modified) food and feed products coming to market.
European Medicines Evaluation Agency (EMEA) was installed as the regulatory gatekeeper for the European market. EU
established that the EMEA's new centralized procedure would be mandatory for virtually all significant biopharmaceutical
The U.S. module of Global Biotechnology Product Registration is the first to provide a comprehensive and up-to-date
analysis of the post-reform FDA Center for Biologics Evaluation and Research and its new licensing process for therapeutic
recombinant DNA-derived products and in vivo monoclonal antibody products. This module covers the complete U.S. biotech
product approval process, from preclinical testing to post marketing regulatory requirements.
S.Prathima is a student of JSS College of Pharmacy, JSS University, Mysore, Karnataka, India. She has completed her B Pharm from JSS College
of Pharmacy, Mysore during the year 2011. Presently she is pursuing M Pharm in Pharmaceutical Quality Assurance in JSS College of Pharmacy,
Mysore. She has attended various National and International Conferences. Her current areas of interest are Quality Assurance, Regulatory Affairs,
Quality Management Systems, GMP Auditing and analytical method development.
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