Bioequivalence guide

June 17, 2011

THE Therapeutic Goods Administration has adopted a new European Guideline on the Investigation of Bioequivalence.. The TGA has added a note that the EU procedure for abridged applications claiming essential similarity to a reference product within the EU doesn’t apply here. “An application for registration of a generic product in Australia should generally include a bioequivalence study versus a leading brand obtained in Australia,” the note states.

The above article was sent to subscribers in Pharmacy Daily's issue from 17 Jun 11
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 17 Jun 11

Other recent headlines

Mayne pushes Sun Pharma
Friday | Jul 26 2024

MAYNE Pharma Group Limited has filed a patent infringement suit against Sun Pharmaceutical Industries Ltd and Inc., in the United States District Court, according to yesterday’s ASX announcement.

Unscripted alcohol debate
Friday | Jul 26 2024

PHARMACY Connect 2024 conference will feature a provocative ‘Great Debate’ during the Harm Minimisation Workshop on Thu 05 Sep at the Hyatt Regency in Sydney.

LTR secures millions in capital raise
Thursday | Jul 25 2024

LTR Pharma Limited has successfully raised $10.5 million through a share placement to sophisticated and new institutional investors, significantly surpassing initial demand.

SEARCH PHARMACY DAILY

Featured video
MORE VIDEOS

Recent issues

PD for Fri 26 Jul 2024
PD for Thu 25 Jul 2024
PD for Wed 24 Jul 2024
PD for Tue 23 Jul 2024
PD for Mon 22 Jul 2024
SEE MORE ISSUES

INDUSTRY JOB VACANCIES

Pharmacist in Charge – SA
Pharmacist Manager – WA
Compounding Pharmacist – Melbourne
Pharmacist in Charge – QLD North
Pharmacist – Sydney North
SEE MORE JOBS

Pharmacy Daily is Australia's favourite online publication dedicated to the pharmacy industry. The publication launched in March 2007 and is distributed every day by email to pharmacists across the country.

PHARMACY DAILY NEWS
Headlines

Jobs

New Products

Events Calendar

FEEDS
News Items RSS feed

PD Issues RSS feed

All content RSS feed

Content & Media
Pharmacy Daily TV

OUR SITES
Sitemap

Travel Daily

Travel Bulletin

Cruise Weekly

Business Events News

Pharmacy Daily

ADVERTISE WITH US
Advertise in Pharmacy Daily

Privacy

ADMIN
Log in

SUBSCRIBE
Sign up for FREE

Subscription Information

"Water, air, and cleanness are the chief articles in my pharmacy." - Napoleon Bonaparte

Copyright © 2018 Pharmacy Daily

Subscribe to Pharmacy Daily now!

FREE Pharmacy Daily subscription - never miss another story!

Name*
First Last
Email*

Profession
Company

Address
City State / Province / Region ZIP / Postal Code Country

By submitting this form I hereby certify that I understand that Pharmacy Daily is a publication for health professionals.
Email
This field is for validation purposes and should be left unchanged.

to top

Pharmacy Daily | Bioequivalence guide

Bioequivalence guide

Other recent headlines

Mayne pushes Sun Pharma

Unscripted alcohol debate

LTR secures millions in capital raise

SEARCH PHARMACY DAILY

Featured video

Recent issues

INDUSTRY JOB VACANCIES