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What's New at FDA  Members only

What's New at EMA Members only

What’s New at MHLW Members only

January 2010

21 Jan 2010 European Medicines Agency gives first opinion on compassionate use
21 Jan 2010 Press release: New appointments to the British Pharmacopoeia Commission
20 Jan 2010 Dutch Medicines Evaluation Board Publishes Annual Notice: growth in the authorisation of medicinal products in 2009
19 Jan 2010 Health Canada Updates "Validation Guidelines for Pharmaceutical Dosage Forms"
15 Jan 2010 US FDA Unveils First Phase of Transparency Initiative


December 2009

30 Dec 2009 China's SFDA issues Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim)
28 Dec 2009 Earlier access to new medicines in the UK
18 Dec 2009 Swedish Medical Products Agency Proposes Stricter Environmental Requirements For the Pharmaceutical Industry
18 Dec 2009 UK's MHRA Announces Public consultation on Measures to strengthen the medicines’ supply chain and reduce the risk from counterfeit medicines
18 Dec 2009 European Medicines Agency’s Management Board endorses the work programme 2010 and strengthens the involvement of patients in the work of the Agency
14 Dec 2009 FDA Announces Final Rule to Amend 21 CFR Parts 210, 211, 212
10 Dec 2009 US FDA Announces New GMP Regulations For PET Drugs and updates to 21 CFR Parts 210 and 211
09 Dec 2009 European Medicines Agency launches new organisational structure and new visual identity
09 Dec 2009 Australia Introduces Fourth Bill to enhance the Therapeutic Goods Act 1989
07 Dec 2009 Malta's Medicines Authority Awarded The Foundation For Human Resources Development - HR Award
04 Dec 2009 TGA Issues New Biologicals Framework Newsletter
04 Dec 2009 PIC/S Issues Technical Interpretation of Revised Annex 1 TO PIC/S GMP Guide
02 Dec 2009 ICH Quality Implementation Group on Q8-Q9-Q10 Has Released a New Set of Q&As
01 Dec 2009 EMEA Announces Several Important Upcoming Changes


November 2009

01 Nov 2009 International operation combats the online supply of counterfeit and unlicensed medicines



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