Drug establishment registration and drug listing Regulation

From June 1, 2009 FDA is no longer accepting paper submissions for drug establishment registration and listing unless a waiver is granted.

Both information were been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments' Report of Private Label Distributors). But now FDA will not accept anything on paper and would rather accept fully compliant electronic submission.

Also by Jan 1, 2010 starting 1 January 2010. Some regulatory authorities in Europe have implemented all electronic review environments ahead of this deadline and are refusing to accept paper submissions for review. Many authorities are receiving the eCTD files with full of error and non compliant submissions and finding difficulty in navigating through it.

Section 510 of the Act and 21 CFR part 207, subject to certain limited exceptions, require establishment owners and operators (registrants) upon first engaging in the manufacture, preparation, propagation, compounding, or processing of drugs, (including human drugs, veterinary drugs, and biological drug products 4 ) to register their establishments and submit listing information for all drugs in commercial distribution. Registrants are also required to submit registration information for their establishments on or before December 31 of each year.

At the time of registration, registrants must also submit required listing information. Additionally, registrants are required to update listing information in June and December of each year to include information for drugs that have not been previously listed. Certain changes to information for previously listed drugs must also be submitted every June and December.

Purpose of this regulation

FDA intends to update these documents regularly to reflect the evolving technology and user experience.

Receipt of timely and accurate information will enhance FDA’s efforts to help ensure the integrity of the drug supply and protect public health.

The electronic drug establishment registration and drug listing system will permit FDA to electronically populate the Agency’s listing databases and the NDC Directory and will, therefore,improve the inclusiveness and accuracy of these databases.

To read details about this regulation please refer following links

Trainings-

http://www.complianceonline.com/ecommerce/control/trainingFocus?product_id=700719

http://www.raps.org/personifyebusiness/ConferencesTraining/PreparingComplianteCTDsAdvanced/tabid/1108/Default.aspx

Regulations doc
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072339.pdf