Replies to post #77884 on NanoViricides Inc. (NNVC)

[Puffer]

FDA and EMA will then review. If the filing is early enough, approval to begin clinical trials could come as early as Q4 2014 or Q1 2015.

The company has previously signaled an intention to start human clinical trials in Australia. They have already expended some resources toward that effort.


Drug Aproval Process In Australia


Any person seeking approval of a new drug in Australia should first file a clinical trial application for conducting human studies. The clinical trials in Australia can be conducted under two schemes, i.e. either under the Clinical Trial Exemption (CTX) Scheme or under the Clinical Trial Notification (CTN) Scheme. In the latter scheme, application is directly submitted to the Human Research Ethics Committee (HREC) which assesses the validity of design of clinical trial, its ethical acceptability, approval, safety and efficacy of the drug as well. The final consent for conducting trial is given by the approving authority after due advice from the HREC. The commencement of clinical trial takes place only after the due notification to the TGA and the appropriate notification fee to be paid. In CTX scheme, an application to conduct clinical trials is submitted to the TGA for evaluation and comment. The clinical trials can be conducted (under the CTX application) without further assessment by the TGA and the conduct of each trial should be notified to the TGA[27,28]. Figure 7 represents the CTA by CTX scheme. An application is submitted to TGA to register the drug in Australian Register of Therapeutic Goods (ARTG) after the completion of clinical trials. The application consists of data to support the quality, safety and efficacy of the product for its intended use. The application is assessed (on an administrative level) to make sure for compliance with basic guidelines and further evaluated by different sections and advice can also be sought on key issues to take final decision. A company can make comments on the evaluation report, if necessary. A delegate (decision-maker) within the TGA after due advice of the ADEC, take a decision to approve or reject the product. The Australian Drug Evaluation Committee (ADEC) usually gives advice for new medicines. Figure 8 represent the new drug approval process in Australia. When the drug is approved and distributed in the market the drug, it is considered to be in Phase IV trials. In this phase, new uses or new populations, long-term effects, etc. can be explored[29,30].

[crashco]

A simple search returns dozens of articles indicating FDA is faster then EMA and others. Do you have contradictory information?

http://www.raps.org/focus-online/news/news-article-view/article/1798/researchers-fda-beats-ema-health-canada-in-drug-approval-times.aspx

http://www.forbes.com/sites/matthewherper/2012/06/19/more-proof-fda-is-faster-than-other-regulators/

http://www.focr.org/events/friends-study-fda-vs-ema-cancer-drug-approvals-release-and-congressional-hearing

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/32727

http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm