The Rheumatologist
COVID-19 News
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / EMA Flags Faulty Generic Drug Data, Backs Sales Halt

EMA Flags Faulty Generic Drug Data, Backs Sales Halt

July 26, 2016 • By Reuters Staff

  • Tweet
  • Email
Print-Friendly Version / Save PDF

(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable.

You Might Also Like
  • U.S. FDA Moves to Prevent Pharma from “Gaming” Generic Drug System
  • U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
  • Spanish Drugmaker Fears Disruption if EMA Moves from Britain

The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The recommendation comes after the U.S. Food and Drug Administration (FDA) and the World Health Organization raised concerns about substitution and manipulation of patients’ clinical samples by Semler Research Centre Pvt Ltd.

The FDA asked drugmakers in April to repeat bioequivalence studies for drugs whose application used data obtained from tests conducted by Semler.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Generic drugmakers have to prove to health regulators through bioequivalence studies that their cheaper copycat drugs are as effective as the drug that they try to mimic.

The EMA review expressed concerns about the bioequivalence of the suspended generics of cancer drug erlotinib (Tarceva), migraine treatment eletripan and anti-malarial drug Atovaquone/Proguanil.

The EU health regulator says it also recommends against approving those drugs whose applications used data from studies conducted at the research site.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

The agency, however, allowed sales of those drugs where the manufacturing company provided data from alternate studies.

The European Commission will make a legally binding decision on these recommendations, the agency says.

Filed Under: Drug Updates, Safety Tagged With: European Medicines Agency, generic drugs, Regulation, Teva Pharmaceuticals

You Might Also Like:
  • U.S. FDA Moves to Prevent Pharma from “Gaming” Generic Drug System
  • U.S. House Panel Spotlights Use of FDA Rules to Slow Generic Drugs
  • Spanish Drugmaker Fears Disruption if EMA Moves from Britain
  • U.S. Could File Charges in Generic Drug Probe by Year-End

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2022 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)