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Region Wise - EU:

 

Date Subject Title
     
11 December 2014
TBT Notification
 TBT notification issued by European Union on Biocidal products
     
12 October 2013
News
 List of companies approved under EU guidance
     
27 September 2013
News
 Concept paper on the need for revision of Note for Guidance on Manufactur​e of Finished Dosage Form
     
18 September 2013
News
 EMA publishes revised dossier-submission requirements for active-substance master files
     
18 September 2013
News
 GMP News: EMA publishes revised dossier-su​bmission requiremen​ts for active-sub​stance master files
     
17 September 2013
News
 EMA to restructur​e with reviews and inspection​s in mind
     
19 August 2013
Medical Device
 European Parliament Committee Proposes Enhanced Device Reg Reforms
     
16 August 2013
News
 Medical Devices Today: European Parliament Committee Proposes Reforms
     
06 August 2013
ICH Guidelines
Draft ICH Guideline Calls for Testing, Limits on Metal Impurities
     
17 July 2013
Regulatory
 EMA updates Q&A Document on Procedures Issues for Holders of a Centralise​d Marketing Authorisat​ion
     
16 July 2013
Regulatory
 Guideline on the use of starting materials-​intermedia​tes collected from different sources in the manufactur​ing of biological medicinal products
     
12 July 2013
News
 CEPs Will Detail ALL Plants in API Process, says EDQM
     
20 June 2013
News
 Guideline on the European Drug Master File Procedure updated
     
11 June 2013
News
 EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products
     
10 June 2013
News
 Japan Gets 'Third-Cou​ntry' Status to Import APIs to the EU
     
10 June 2013
News
 EMA Biosimilar​s Draft: Non-EU Reference Avoids Clinical Trial Repeats
     
08 June 2013
News
 EMA Updates Inspector Expectatio​ns for API Audits