Regulatory Authorities Across the World and their Reporting Systems
Introduction:
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory authorities and organizations are responsible for effective drug regulation required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public. Regulatory bodies provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.
Definition:
Regulatory Authorities are government-created institutions that regulate, supervise, and govern diverse industries like insurance, finance, education, and healthcare. Each sector in India has its Regulatory Authority.
Objective:
The present study describes a brief review of various regulatory bodies of major developed and developing countries around the world and the scope and challenges of such pharmaceutical regulatory organizations in delivery of safe and effective healthcare products.
Drug Development Process and Regulatory Role:
New drugs begin in the laboratory with scientists, including chemists and pharmacologists, who identify cellular and genetic factors that play a role in specific diseases. They search for chemical and biological substances that target these biological markers and are likely to have drug-like effects. Out of every 5,000 new compounds identified during the discovery process, approximately five are considered safe for testing in human volunteers after preclinical evaluations. After three to six years of further clinical testing in patients, only one of these compounds on average is ultimately approved as a marketed drug for treatment.
Responsibilities of Regulatory Authorities:
Regulatory bodies are staffed by specialists who are versed in the complexities of regulations and how to best enforce them. Their responsibilities also include:
Drafting rules
Protecting consumers
Adjudicating dispiutes and controversies
Conducting hearings
Providing ordinary administrative services
Major Regulatory Agencies World Wide:
Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.
Clinical Investigation
US: IND – Investigational New Drug (Application)
EU: CTA / CTX – Clinical Trial Authorization/Clinical Trials Exemption
Marketing Approval
US: NDA – New Drug Application ,
ANDA - Abbreviated New Drug Application,
BLA – Biologic License Application
EU: MAA – Marketing Authorization Application
CTD–Common Technical Document, Common format for marketing authorization (registration)
Conclusion:
Regulatory agencies and organizations around the world need to ensure the safety, quality and efficacy of medicines and medical devices, harmonization of legal procedures related to drug development, monitoring and ensure compliance with statutory obligations. However,, the need of the hour is
* More centralized procedures in drug regulation
* Harmonization of regulatory norms
* Strengthening the regulatory authorities
1. Rohilla, Dhulichand; Dureja, HarishDr., New Drug Approval Process: Regulatory View, Pharmainfo.net, 2010.(assessed on Sept 5th 2011).
2. Governement and regulatory bodies around the world, pharmweb.net/pwmirror/pwk/pharmwebk.html.(assessed on Sept 8th 2010).
3. Meadows, M. The FDA’s Drug Review Process: Ensuring Drugs are Safe and Effective (2002). fda.gov/fdac/features/2002/402_drug.html (assessed on Sept. 10th 2011)
Student Name: Khateeb Arshad
Student ID: 001/012023
Qualification: M Pharmacy
e-Mail ID: syedarshadkhateeb@gmail.com
Comments