1 |
31 Mar 2016 |
Notification issued by European Union On chemical substances classified as drug precursors |
TBT Notification |
EU |
2 |
27 Nov 2015 |
EU amends authorisation procedure for biocidal products |
TBT Notification |
EU |
3 |
19 Jun 2015 |
EMA makes 'a number of changes' to improve product information |
Regulatory |
EU |
4 |
11 Dec 2014 |
TBT notification issued by European Union on Biocidal products |
TBT Notification |
EU |
5 |
12 Oct 2013 |
List of companies approved under EU guidance |
News |
EU |
6 |
27 Sep 2013 |
Concept paper on the need for revision of Note for Guidance on Manufacture of Finished Dosage Form |
News |
EU |
7 |
18 Sep 2013 |
EMA publishes revised dossier-submission requirements for active-substance master files |
News |
EU |
8 |
18 Sep 2013 |
GMP News: EMA publishes revised dossier-submission requirements for active-substance master files |
News |
EU |
9 |
17 Sep 2013 |
EMA to restructure with reviews and inspections in mind |
News |
EU |
10 |
19 Aug 2013 |
European Parliament Committee Proposes Enhanced Device Reg Reforms |
Medical Device |
EU |
11 |
16 Aug 2013 |
Medical Devices Today: European Parliament Committee Proposes Reforms |
News |
EU |
12 |
06 Aug 2013 |
Draft ICH Guideline Calls for Testing, Limits on Metal Impurities |
ICH Guidelines |
EU |
13 |
17 Jul 2013 |
EMA updates Q&A Document on Procedures Issues for Holders of a Centralised Marketing Authorisation |
Regulatory |
EU |
14 |
16 Jul 2013 |
Guideline on the use of starting materials-intermediates collected from different sources in the manufacturing of biological medicinal products |
Regulatory |
EU |
15 |
20 Jun 2013 |
Guideline on the European Drug Master File Procedure updated |
News |
EU |
16 |
11 Jun 2013 |
EMA Releases New Guideline Meant to Clarify Process for Naming Drug Products |
News |
EU |
17 |
10 Jun 2013 |
Japan Gets 'Third-Country' Status to Import APIs to the EU |
News |
EU |
18 |
10 Jun 2013 |
EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats |
News |
EU |
19 |
08 Jun 2013 |
EMA Updates Inspector Expectations for API Audits |
News |
EU |
20 |
12 Mar 2013 |
CEPs Will Detail ALL Plants in API Process, says EDQM |
News |
EU |