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NSF has launched a new revitalized website 21 Aug 2013 | 03:37 pm
NSF-DBA is proud to be part of NSF International and wishes to share with you the news that NSF has launched a new, revitalized website. It not only showcases the services of other parts of the NSF He...
UK finally implements the FMD 21 Aug 2013 | 01:56 pm
The Falsified Medicines Directive (Directive 2011/62/EU) has finally been transposed into UK legislation and comes into force today. The Falsified Medicines Directive is transposed through The Human ...
Withdrawn FDA Guidance 16 Aug 2013 | 04:00 am
On 7 August 2013 CDER announced that it was withdrawing several old (issued before 2010) draft guidances because they were “out of date, thus of little use to the pharmaceutical industry”. Among the g...
Global Capabilities, Local Service - Expansion without Compromise 12 Aug 2013 | 07:00 pm
NSF Health Sciences Division – Three New Companies to Serve Three Critical Industry Sectors Since our foundation in 1986, we have risen to become a major global provider to the Pharmaceutical and Med...
ICH Q3D - Elemental Impurities 8 Aug 2013 | 02:27 pm
The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and entered the consultation period (Step 3). The regulatory authorities in the ICH regions of the EU, Ja...
Draft Annex 16: QP Certification and Batch Release 16 Jul 2013 | 07:13 pm
The draft revision to Annex 16, Certification by a Qualified Person and Batch Release, which was published on 5 July is a complete re-writing of this annex. The reason for the revision is given as the...
US FDASIA Implementation 15 Jul 2013 | 04:00 am
On 15 July 2013 the FDA announced a proposed regulation to implement administrative detention authority with respect to drugs as authorized by amendments made to the Federal Food, Drug, and Cosmetic A...
Dr Ian Hudson appointed as the MHRA’s new Chief Executive 4 Jul 2013 | 04:00 am
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) today announced the appointment of Dr Ian Hudson as its Chief Executive. He will take up the post in September when current Chief Ex...
NSF-DBA’s Neil Wilkinson at the PDA-FDA Supply Chain conference in Washington DC 1 Jul 2013 | 01:41 pm
NSF-DBA’s Neil Wilkinson spoke at the recent PDA-FDA Supply Chain conference in Washington DC. The event was a great success with good attendance from the Pharma industry, our Suppliers and FDA person...
Letter from DG SANCO on API importation into the EU 25 Jun 2013 | 08:48 pm
On 19 June the Director General (DG SANCO) of the European Commission, Mrs Paola Testori Coggi, sent a letter to several European trade associations (EGA, EFPIA, EUCOPE and AESGP) on the subject of AP...
