Regulatory affairs on health Canada

Authors

  • R.Suthakaran Department of Pharmaceutical Chemistry and Regulatory Affairs. Vijaya College of Pharmacy, Munaganoor, Hyderabad ,Telangana, India
  • P. Sambasivarao Department of Pharmaceutical Chemistry and Regulatory Affairs. Vijaya College of Pharmacy, Munaganoor, Hyderabad ,Telangana, India
  • M. Ramesh Department of Pharmaceutical Chemistry and Regulatory Affairs. Vijaya College of Pharmacy, Munaganoor, Hyderabad ,Telangana, India
  • V.Padma Department of Pharmaceutical Chemistry and Regulatory Affairs. Vijaya College of Pharmacy, Munaganoor, Hyderabad ,Telangana, India
  • Raju.Manda Department of Pharmaceutical Chemistry and Regulatory Affairs. Vijaya College of Pharmacy, Munaganoor, Hyderabad ,Telangana, India

DOI:

https://doi.org/10.61096/ijpar.v6.iss4.2017.635-644

Keywords:

European Medicines Agency, Sarbanes-Oxley compliance, Food and Drug Administration

Abstract

Regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, banking, telecom etc. Regulatory affairs also  has a very specific meaning within the  healthcare industries ( pharmaceuticals, medical devices, biologics and functional foods). Regulatory affairs (medical affairs) professionals (aka regulatory professionals) usually have responsibility for the  following  general  areas:  Ensuring  that  their  companies  comply  with  all  of  the  regulations  and  laws pertaining to their business. Working with federal, state, and local regulatory agencies and personnel on specific issues    affecting    their    business.    i.e.     working    with    s uch     agencies    as     the Food    and     Drug Administration or European  Medicines  Agency (pharmaceuticals  and  medical  devices);  The  Department  of Energy; or the Securities and Exchange Commission (banking).Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the "regulatory climate" around issues such as the promotion of prescription drugs and Sarbanes -Oxley compliance.

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Published

2022-10-12

How to Cite

R.Suthakaran, P. Sambasivarao, M. Ramesh, V.Padma, & Raju.Manda. (2022). Regulatory affairs on health Canada. IJPAR JOURNAL, 6(4), 635–644. https://doi.org/10.61096/ijpar.v6.iss4.2017.635-644