EMA Suspends 136 Drugs Due to Flawed Bioequivalence Studies
The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed bioequivalence studies performed at the Semler Research Centre in India.
Medicines for which bioequivalence studies were conducted at Semler are under scrutiny after an inspection of the research site found “substitution and manipulation” of study samples, EMA stated in a report published July 22. The World Health Organization found data integrity issues and manipulation of study samples during its inspection of Semler’s bioanalytical and clinical sites.
The potentially suspended generic medicines affect manufacturers ranging from Sandoz and Teva to Mylan and Lupin.
EMA noted that EU member-states could temporarily postpone the suspension if the affected medicines are of critical importance.
A list of EMA’s suspended drugs can be found here: www.fdanews.com/07-22-16-EMARecommendedSuspension.pdf. — Joya Patel
Subscribe to Drug GMP Report NOW and save $200 off the regular one-year price of $1,045. Plus receive a free copy of our webinar CD - GAMP Classification for Pharma Equipment and Software Systems - $287 value.
LINKS TO KEY DOCUMENTS — You get links to key documents that support DGR's articles such as draft and final guidances, Form 483s, warning letters, proposed rules, closeout letters and much more.
FDANEWS DRUG DAILY BULLETIN — This daily email alert brings you targeted FDA regulatory, legislative and business news briefs in the pharmaceutical and biologics industries.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing