Lost Password? No account yet? Register
Member Area

FarmavitaR+ : Regulatory Affairs Network

Thursday
Nov 20th
Home arrow Databases
Databases Print E-mail
Written by Administrator   
Sunday, 12 August 2007

Public Professional Pharma Databases 

We are providing links to several professional databases which you may find helpful: 

MRI Product Index - European Product Index

This Product Index includes medicines approved in the Member States of the European Union according to the procedure for Mutual Recognition.

Electronic Orange Book - US Product Index

This databases includes medicines approved in the USA. For innovative products provided is information about data exclusivity and expiry dates of basic patents.  Database is updated daily. 

Drugs@FDA

FDA database of registered drugs.

Drugs in Russia

Database of drugs registered in Russia (Russian Language)

EU COS Database

This database enables you to obtain information about manufacturers of active ingredients with European Certficate of Suitability 

FDA Drug Master Files Database

Excel file with list of all active DMF`s, approved manufacturers and facilities is available for download at repository of Farmavita.Net.

EDQM - Knowledge Database  

This database enables you to obtain information on a given substance or general method of analysis. The database contains information such as the monograph number, English, French and Latin titles, the state of work, the last issue of the Pharmeuropa in which the draft of the monograph was published, the most recent publication of the text in the European Pharmacopoeia, whether the monograph is currently undergoing revision, the chromatogram in pdf format, and the trade names of some reagents, such as chromatography columns and biological kits.

Generic Drug Patent Challenge Notifications

According to CFR 314.94(a)(12)(i)(A)(4) ...the applicant shall provide the patent number and certify, in its opinion and to the best of its knowledge, ...that the patent is invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the drug product for which the abbreviated application is submitted. The applicant shall entitle such a certification "Paragraph IV Certification".

Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an Abbreviated New Drug Application (ANDA) with the FDA has the exclusive right to market the generic drug for 180 days. 

USPTO - US Patents

Database with US Petents issued from 1975 until present.

esp@cenet - EU PAtents

esp@cenet is an entry-level, internet-based patent document search service offered free of charge. It provides basic search and retrieval functions on a range of patent and patent-related documents. As an entry-level service esp@cenet can be a new user's first experience with patent information. For more experienced users, esp@cenet can be a first choice when beginning each new search, before moving on to more sophisticated, professional level, search tools.

 

 

Last Updated ( Thursday, 23 August 2007 )
 
Advertisement

Newsletters

Sponsors


Regulatory Affairs

RA Section

News

Click to News

Reports

Click to Reports

Events

Click to Events

Intellectual Property

IP Section