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Regulatory Update | 21 May 2012

World: Regulatory Agencies Attend WHO Seminar

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Numerous regulatory agencies met on 18 May in Geneva, Switzerland to discuss whether it is possible to find new ways to allow their drug regulatory bodies to cooperate.The meeting, an international [Read More...]


Regulatory Update | 21 May 2012

Brazil: Anivsa Sets Confidentiality Criteria

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A notice (Ordinance No. 748-B/2012) published by Anvisa on 18 May sets forth the criteria the agency will use for classifying materials as confidential and thus ineligible for release under the Access [Read More...]


Regulatory Update | 21 May 2012

Brazil: Anivsa Implements Freedom of Information Law

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Greater transparency is an integral part of the reorganization of Brazil’s national regulatory agency, Anvisa, and the agency will now release upon written request copies of all documents in its [Read More...]


Regulatory Update | 18 May 2012

China: China Signs MOU with the Ukraine

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On 17 May 2012, Yin Li, commissioner of the Chinese State Food and Drug Administration's (SFDA), signed a bilateral Memorandum of Understanding (MOU) with the Deputy Director of the Ukrainian State [Read More...]


Regulatory Update | 17 May 2012

UK: Price Cut Opens Access to New Prostate Cancer Drug

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The UK’s National Institute for Clinical Excellence (NICE) has issued a “final appraisal determination” recommending the use of abiraterone, in combination with glucocorticoids, for the second-line [Read More...]


Regulatory Update | 17 May 2012

China: SFDA Amends OTC Manual for Amantadine Hydrochloride Compounds

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The Chinese State Food and Drug Administration (SFDA) issued a Notice to Provinces, Autonomous Regions, and Municipalities on 16 May revising the instructions in the Chinese non-prescription drugs [Read More...]


Regulatory Update | 14 May 2012

Brazil: New Agreement Paves Way for Manufacturing Facilities to Produce Multiple Drug Types

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Based on a 7 May agreement between Brazil’s National Health Surveillance Agency (ANVISA) and the Ministry of Agriculture, Livestock and Supply (MAPA), companies will be allowed to produce drugs for [Read More...]


Regulatory Update | 14 May 2012

Brazil: South American Countries Driving Regulatory Harmonization

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Brazil and Argentina are drivers of regulatory harmonization regionally in South America, said Anvisa Chief Executive Dirceu Barbano, noting the countries’ efforts in the region.Both Brazil’s and [Read More...]


Regulatory Update | 14 May 2012

Brazil: Anvisa Restructuring to Meet Social, Economic Development Goals

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The Chief Executive of Brazilian regulatory authority Anvisa says the ongoing restructuring process at the agency is focused on the economic and social development of the country.The agency reforms [Read More...]


Regulatory Update | 11 May 2012

UK: New Prostate Cancer Drug Extends Life, But NICE Against Reimbursement

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Despite the recognized life extending benefits of Sanofi’s new prostate cancer drug, Jevtana (cabazitaxel), the UK's National Institute for Health and Clinical Excellence (NICE) has recommended [Read More...]


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