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Pharmaceutical Regulatory Agencies | Open Access Journals
Pharmaceutical Regulatory Affairs: Open Access

Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Pharmaceutical Regulatory Agencies

 

 

As the pharmaceutical industries throughout the globe are moving ahead towards turning into additional and competitive, regulatory agencies are established in many countries across the world. Regulatory agencies and organizations play a significant role in meeting the legal procedures associated with the drug development method. In the present state of affairs, prescribed drugs are thought of because of the most extremely regulated industries worldwide. The restrictive body ensures compliances in numerous legal and restrictive aspects of a drug. Each country has its own administrative unit that is accountable to enforce the principles and rules and issue the rules to control drug development methods, licensing registration, producing, promoting, and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China), NAFDAC(Nigeria), MEDSAFE (New Zealand), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), Mohr (Sri Lanka) are the few regulatory agencies and organizations established in individual countries.
World Health Organization (WHO), Pan Yankee Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), World property Organization (WIPO) are a number of international regulatory agencies and organizations that additionally play essential role altogether aspects of pharmaceutical rules associated with drug product registration, producing, distribution, control, marketing, analysis and development, and property protection. The major challenges of those restrictive agencies and organizations around the world are to confirm the protection, quality, and efficaciousness of medicines and medical devices, harmonization of legal procedures associated with drug development, observance, and guaranteeing compliance with statutory obligations. They additionally play a significant role to confirm and increase restrictive implementation in non-regulated elements of the globe for the safety of individuals residing there. The current study describes a short review of assorted restrictive bodies of major developed and developing countries and also the scope and challenges of such restrictive organizations in drug development and delivery of safe and effective care products to people around the world.

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Citations: 533

Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report

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