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Regulatory Update | 23 May 2013

EU Health Cost Containment Panel Members Nominated

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The European Commission has released the names of the first members to sit on the panel of experts it established in 2012 to provide advice to Member States on ways to contain healthcare Read More...


Regulatory Update | 20 May 2013

China Announces Electronic Monitoring Deadlines for Imported Drugs

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The China Food and Drug Administration (CFDA) has issued a notice setting deadlines for implementing electronic monitoring for imported essential drugs. Imported drugs in domestic packaging must Read More...


Regulatory Update | 20 May 2013

Regulators Consider New International Coalition of Drug Agencies

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International regulatory authorities are involved in discussions regarding the possible creation of a new International Coalition for Drug Regulatory Agencies (ICDRA), the Brazilian regulatory agency Read More...


Regulatory Update | 17 May 2013

EU’s Scientific Committees to Look at Synthetic Biology

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The European Commission’s three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its Read More...


Regulatory Update | 15 May 2013

Corrected: CFDA Issues API Export Instructions to Provinces

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China’s Food and Drug Administration (CFDA) last week issued instructions to Chinese provinces regarding the requirements for certifying active pharmaceutical ingredient manufacturers for the right to Read More...


Regulatory Update | 14 May 2013

TGA Opens Consultation on New-to-Market Communication Proposal

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Australia's Therapeutic Goods Administration (TGA) has opened a consultation to seek views from interested parties on the value, feasibility, design and impacts of a proposed new-to-market risk Read More...


Regulatory Update | 13 May 2013

Brazilian House Holds Hearing on Anvisa Regulatory Authority

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The Committee on Social Security and Family of Brazil’s House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil’s National Health Surveillance Agency Read More...


Latest News Regulatory Update | 6 May 2013

Australia Opens Consultation on Proposed IVD Amendments

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Australia’s Therapeutic Goods Administration (TGA) has opened a consultation on proposed amendments to the new regulatory framework for in vitro diagnostic devices (IVDs) that covers both commercially Read More...


Latest News Regulatory Update | 2 May 2013

NICE Assuming New Duties, Will Assist NHS With Use of Innovative Medical Devices

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The UK’s cost containment agency, the National Institute for Health and Care Excellence (NICE), will soon begin to directly assist the National Health Service (NHS) with the use of innovative new Read More...


Regulatory Update | 25 April 2013

NICE Gives Novartis’ Asthma Drug Thumbs Up After Price Lowered

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The UK’s cost containment agency, the National Institute for Health and Care Excellence (NICE), has given its approval in final guidance for the reimbursement of Novartis’ Xolair (omalizumab) for the Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more


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