BfArM - Federal Institute for Drugs and Medical Devices

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Processing Statistics of the BfArM 2008 PDF, 351KB, File does not meet accessibility standards Date: 23. March 2009 Topics: Licensing Type: Download

State: March 2009

List of Change Items Version 1.6 PDF, 77KB, File does not meet accessibility standards Date: 11. March 2009 Topics: Licensing Type: Form

German - English

Explanatory Notes on the enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products PDF, 496KB, File does not meet accessibility standards Date: 29. January 2009 Topics: Licensing Type: Download

Explanatory Notes on the enforcement of the Ordinance on the Submission of Documents within Licensing and Renewal Procedures for Medicinal Products

Are there specific data requirements for clinical trials with children? Date: 13. January 2009 Topics: Licensing Type: FAQ

Yes, in accordance with the "Guideline on the Need for Non-Clinical Testing in Juvenile Animals on Human Pharmaceuticals for paediatric indications" for all clinical trials with children studies of repeated-dose-toxicity, genotoxicity, …

Presentation of documentary evidence pursuant to Article 7 of the European Paediatric Medicines Regulation (EC) no. 1901/2006, mandatory from 26 July 2008 Date: 13. January 2009 Topics: Licensing Type: Article

Presentation of documentary evidence pursuant to Article 7 of the European Paediatric Medicines Regulation (EC) no. 1901/2006, mandatory from 26 July 2008

EU-regulation on medicinal products for children Date: 13. January 2009 Topics: Licensing Type: Article

EU-regulation on medicinal products for children

Advice on the submission of information about use of authorised medicinal products in children as required by Articles 45 and 46 of the Paediatric Medicines Regulation (EC) no. 1901/2006 Date: 13. January 2009 Topics: Licensing Type: Article

Advice on the submission of information about use of authorised medicinal products in children as required by Articles 45 and 46 of the Paediatric Medicines Regulation (EC) no. 1901/2006

Which information should be included in the cover letter? Date: 09. December 2008 Topics: Licensing Type: FAQ

For every CTA, please provide information about previous submissions / filings (submission number) appropriate to the Investigational Medicinal Product in the cover letter.

If a scientific advice meeting with the competent authorities of …

What are the requirements for first-in-man clinical trials from a clinical point of view? Date: 02. December 2008 Topics: Licensing Type: FAQ

In the cover letter, it should be mentioned that within the clinical trial a medicinal product is meant to be administered in humans for the first time. In this context, it should already be discussed whether the medicinal product is a potential …

Which formal deficiencies are most frequently found in application documents? Date: 02. December 2008 Topics: Licensing Type: FAQ

Often, there is no justification pursuant to Section 7 sub-section 2 number 12 of the GCP Ordinance specifying the appropriateness of the chosen sex distribution of trial subjects for detecting possible sex-specific differences in the efficacy …