Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 19 June 2013 | By Ansis Helmanis,
Australia's Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or Monograph application) route to market.
N2 applications will involve significantly reduced requirements for data assessment and consequently shorter evaluation timelines. Instead of providing full supporting data with the application, sponsors will only need to confirm that the product meets the specified monograph requirements.
The proposal includes the publication of three OTC monographs covering the most commonly registered OTC products: those containing aspirin, paracetamol and ibuprofen as single active ingredients. Additional monographs will be developed and implemented during the trial period.
The deadline for comment is 16 July 2013.
TGA: OTC Consultations
Read all Breaking News from RegLink
Tags: Monograph, OTC, australia