Messages in brief
Drug quality: potential for improving documentation
Based on recent follow-up requests from the Drug Quality and Regulatory Affairs National Procedures Divisions, a list of the most frequently submitted…
Electronic Submission Ordinance 2011
On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications…
Medical devices: Information on hip implants
Hip joint endoprostheses are medical devices of the highest risk class (class 3). These medical devices must undergo a development program with…
eServices platform: Web portal for pharmaceutical imports
Before using the web portal for the first time, registration of the organization is required. In the process, the authorization within the meaning of…
Monitoring of medicinal products of Japanese origin
Girls Day 2011
Herbal medicinal products: Directive 2004/24/EC
The background to the recent discussions is not a 'new' document from the European Commission, but the 2004 Directive 2004/24 EC, which defines…
Information on vaccination incidents in Japan
Prevenar (active ingredient: pneumococcal polysaccharides of serotype 4, 6B, 9V, 14, 18C, 19F and 23F, conjugated to CRM197 carrier protein, adsorbed)…
Clinical Trials
Marketing Authorisation & Lifecycle Management
