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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 (ICMRA), the Brazilian regulatory agency 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 | 15 April 2013

Brazil Revises Patent Prior Consent Rules

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The board of Brazil’s National Health Surveillance Agency (Anvisa) has approved updated rules for the agency’s prior consent assessment of patent applications for medicines. The new rules establish a Read More...


Regulatory Update | 11 April 2013

Brazil's Anvisa Looks to Streamline Registration Procedures for Drugs, Devices

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Brazil’s National Health Surveillance Agency (Anvisa) has signed a technical cooperation agreement with two other Brazilian agencies designed to sustain the country’s economic growth and health by Read More...


Latest News Regulatory Update | 8 April 2013

Brazil Releases Guidance on Drug Manufacturing Decontamination Validation

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Brazil’s National Health Surveillance Agency, Anvisa, has released a pharmaceutical production cleaning validation guide which, according to the agency, is based on international guidelines. The Read More...


Latest News Regulatory Update | 4 April 2013

Brazil Proposes Electronic Tracking System for Drugs

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Brazil’s National Health Surveillance Agency (Anvisa) has proposed the formation of an electronic tracking system for drugs that would follow a drug from the point of manufacture to its dispensation Read More...


Latest News Regulatory Update | 25 March 2013

Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections

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Brazil’s National Health Surveillance Agency (Anvisa) has announced the adoption of a set of measures intended to modernize and expedite the marketing approval review process for new products subject Read More...


Latest News Regulatory Update | 18 March 2013

Brazil Introduces New Online System for Minor Changes to Package Inserts

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Brazil’s National Health Surveillance Agency, Anvisa has announced the creation of a new system for filing petitions for minor changes to package inserts through a new online portal on the agency’s Read More...


Regulatory Update | 11 March 2013

Anvisa Signs Cooperative Agreement with Brazil's Anti-Trust Agency

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Brazil’s National Health Surveillance Agency (Anvisa) has signed a Technical Cooperation Agreement (TCA) with the Administrative Council for Economic Defense (Cade) in order to investigate potentially Read More...


Regulatory Update | 19 February 2013

Brazil Opens Consultation on 2013-14 Regulatory Agenda

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Brazil’s National Health Surveillance Agency (Anvisa) has opened up its 2013-2014 Regulatory Agency for public consultation and comments, it announced this week.The Preliminarily Proposed Themes were 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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