Updated on 25 April 2014
That said, they specified that as per their estimates, India is third largest when it comes to volume and eight largest when it comes to price. One out of five formulations are from India. The potential of need for help with understanding regulations is amongst the highest here, they opined.
FDA's efforts towards harmonization
FDA's role in harmonization and multilateral relations is to coordinate and collaborate on activities with various international organizations and governments on international standards and harmonization of regulatory requirements.
Recognizing the considerable synergy between its domestic policy and its international policy priorities, FDA is sharpening and focusing its planning for enhanced alignment of FDA and international standards. In recent decades, great changes in the world economy, together with expanded working relationships of regulatory agencies around the globe, have resulted in increased interest in international harmonization of regulatory requirements. Increased international commerce, opportunities to enhance public health through cooperative endeavors, and scarcity of government resources for regulation have resulted in efforts by the regulatory agencies of different nations to work together on standards and harmonize their regulatory requirements. Such harmonization enhances public health protection and improves government efficiencies by reducing both unwarranted contradictory regulatory requirements and redundant applications of similar requirements by multiple regulatory bodies. FDA's goals in participating in international harmonization are:
• To safeguard global public health,
• To assure that consumer protection standards and requirements are met
• To facilitate the availability of safe and effective products
• To develop and utilize product standards and other requirements more effectively
• To minimize or eliminate inconsistent standards internationally
FDA's harmonization efforts are intended to pool regulators' resources in developing standards for public health protection; reduce industry's compliance costs in the global market, and minimize impediments to bringing safe food and safe and effective treatments to consumers and patients around the world.
Source: FDA Website