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  • Brazil: Regulation Seen as Supporting Social And Economic Development

    Brazil's national regulatory agency, Anvisa, and the Ministry of health have announced the joint recognition of regulation as a benefit for social and economic development under a new Memorandum of Understanding published 13 June. Anvisa had argued on behalf of the arrangement, saying its surveillance activities were "strategic" and worked to advance more than just good products. "Every step we take in the surveillance area, multiply the reduction of spending sustainabil...
  • Brazil: Risk Management Plans Shouldn't Prevent Drug Access for Generic Companies

    A proposed new standard that defines the criteria for inclusion and exclusion of drugs in list of drugs used as the reference drugs by generics (Reference Listed Drug) was adopted by the Board of Brazil's national regulatory agency, Anvisa, on 14 June. A key provision of the proposal would require the reference drug manufacturer to provide the drug for purchase by a generic company. The purpose of the provision is to ensure that generic companies can obtain the d...
  • China: Milestone Meeting Held Between Chinese, Taiwanese Regulators

    The first "cross-strait" Pharmaceuticals Inspection Technology seminar was jointly organized by the Chinese Food and Drug Testing and Research Institute, the Taiwanese Food and Drug Administration, and the Fujian Institute for Drug Control and held in Fuzhou, Fujian, on 6-7 June 2012. The seminar served to actively implement the bilateral "cross-strait medical and health cooperation agreement" signed by the Fujian Provincial People's Government and the State Food and ...
  • China: SFDA Issues New Draft Excipient Rules

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June to require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production. Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the...
  • Brazil: Meeting to Discuss New Criteria for Therapeutic Indications

    The Board of Anvisa, the national regulatory authority of Brazil, is scheduled to review new regulations governing the format of "non-print" instructions for use of health products and the criteria for a therapeutic indication at its next public meeting. The Board will also receive a report by the Chief Executive Officer of Anvisa, Dirceu Barbano, on the international meeting of national regulators held in Geneva on 18 May that was organized by the agency on the topic of...
  • Brazil: Anvisa Publishes New GMP Inspection Guide

    Brazil's national regulatory agency, Anvisa, has published a new guide for pharmaceutical companies and local inspectors on the good manufacturing practices (GMP) principles and practices mandated nationally in 2010.  The guide includes a Q&A section and provides a fundamental basis for a company to understand and comply with quality regulatory requirements. The contents of the guide are based on international benchmarks, as well as national experience. R...
  • Brazil: Regulatory Agency Gets Authority to Deny Patents

    As the result of a new patent review process, Brazilian regulatory authority Anvisa is being given the authority to deny the grant of a patent for a medical product. The agency can make deny a decision to grant a patent if it determines the patent would impede universal access to medicines-a Brazilian constitutional right. This so-called right of "prior consent" by Anvisa would be binding on Brazil's Patent and Trademark Office (INPI). Read more: Patent Review Proc...
  • Brazil: New Quality Standards for Excipients

    Brazil's national regulator, Anvisa, will open a public consultation on establishing quality requirements for pharmaceutical excipients used in the manufacture of medicinal products. Excipients include additives such as diluents, flavoring agents and antioxidants. The  Public Consultation No. 31 , published 28 May, provides for 60 days of comment beginning June 4 2012.  Comments can be submitted using the Ministry of Health's electronic system, FormSUS. Rea...
  • China: SFDA Proposes Blacklisting Companies

    China's State Food and Drug Administration (SFDA) has issued a draft "blacklist" proposal that would be used for listing serious violators of laws and regulations. The 28 May list was sent to provinces and municipalities, and contains examples of the kind of violations that would support blacklisting a company. Examples provided include sales of counterfeit drugs, production and sale of inferior drugs, failure to obtain medical device registration certificate and de...
  • Brazil: New IVD Guidance Aims to Assist Small Businesses

    A new guidance manual for the in vitro diagnostic (IVD) business sector is intended to assist companies in how to obtain the right to market their products in Brazil.  The Manual was developed by Brazil's national regulatory agency, Anvisa, in collaboration with the Brazilian Agency for Industrial Development (ABDI) and the Agency for Support to Entrepreneurship and Small Business (Sebrae).  The collaborative effort is especially intended to assist local com...
  • World: Regulatory Agencies Attend WHO Seminar

    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 seminar hosted by the World Health Organization (WHO), included representatives from Australia, Argentina, Brazil, France, India, Portugal, South Africa, the United States and the UK. A total of 30 regulatory agencies attended the meeting. The meeting coincided with the WHO'...
  • Brazil: Anivsa Sets Confidentiality Criteria

    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 to Information Act, which recently went into effect.  Examples of what would be classified as non-releasable is information relating to: scientific studies and research projects in progress, intelligence activities, ongoing monitoring, and information treated as con...