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  • Brazil: Regulators Partner With Government to Advance Regulatory Science

    Brazil's National Health Surveillance Agency (Anvisa) and the National Council for Scientific and Technological Development (CNPq) are partnering on an initiative to financially support projects that would "significantly contribute" to innovation in the regulatory sciences, Anivsa said in a 4 September announcement. Both CNPq -- a government agency that acts to promote science in technology in Brazil -- and Anvisa jointly  published on 31 August a public...
  • Brazil: Strike May Prompt Drug Shortages

    [Editor's note: the majority of Brazilian regulatory authorities ended their strike on Monday, 3 September 2012 according to Reuters . Approximately 10% of workers remain on strike.] The Brazilian press is claiming that the ongoing strike of employees at the country's National Health Surveillance Agency, Anvisa, is threatening to create drug shortages throughout the country.   "In the hospitals, concerns have grown over shortages of essential medicines an...
  • Australia: TGA Restricts OTC Cough and Cold Medications

    Australia's Therapeutic Goods Administration (TGA) has concluded that over-the-counter (OTC) cough and cold medicines registered with the agency should not be given to children under the age of six, and should be given only on the advice of health professionals for those ages six to 12. The restrictions stem from a review of the safety and efficacy of these products conducted by the agency that found although there are no immediate safety risks associated with the pro...
  • Brazil: New Drug and Device Import Rules Issued

    New import rules ( RDC 43 ) released by Brazilian regulatory authority Anvisa on 6 August clarify that products subject to regulation may obtain import approval if the import license application is not examined within five working days from the date of request by the importer.  The new rules cover situations where a labor strike-such as the one recently launched by many Anvisa regulators -or other event slows down the import administrative process or when th...
  • Indian Regulators Release Draft Clinical Trial Rules

    India's Ministry of Health has released three new draft rules governing the approval of clinical trials in India , the registration of ethics committees in charge of reviewing and approving investigation protocols and the compensation payable to patients enrolled in clinical trials in the case of injury or death. Clinical trials must first be registered with India's Clinical Trial Registry before patient enrollment can proceed.  The trial sponsor or clinical tr...
  • Canada: New Safety Labeling Guidance for Aspirin Products

    Newly proposed safety-related revision from Canadian regulators will apply to acetylsalicylic acid (ASA)-containing products, and contains proposed limits for over-the-counter (OTC) use. The product, more commonly referred to as aspirin, is increasingly found in combination products containing, for example, codeine and caffeine. The draft proposal responds to adverse event reports concerning overdoses from products containing ASA, as well as risks to infant health posed...
  • Brazilian Consumers Allowed to Purchase OTC Drug Products Under New Rules

    Brazilian consumers will not be able to purchase over-the-counter drug products at pharmacies according to new rules published 17 July 2012 by Brazilian health regulator Anvisa. Under the new rules, the OTC products may be purchased in a manner similar to cosmetics and dietary supplements,regulators explained. OTC drugs must be organized on pharmacy shelves by active ingredient with the cautionary statement that drugs may cause unwanted side effects.  Anvisa open...
  • Brazilian Regulators Go On Strike

    Brazilian government officials, including those at the regulatory agency Anvisa, have gone on strike, leaving the agency critically under-staffed and scrambling to make sure its basic operational functions are maintained. Anivsa said in a statement that the Brazilian Supreme Court has ordered it to ensure at least 30% of its work force remains on the job during a  strike of the regulatory agency's workers . Anvisa has reportedly assured industry that the agency...
  • EU: New European Healthcare Advisory Panel Formed

    The European Commission adopted a Decision on 6 July to establish an independent expert panel to advise the Commission on "effective ways" to make Member State healthcare systems economically sustainable.  The new advisory group will consist of 17 experts from several areas of health-related expertise, including pharmaceuticals and research and development.  Member States are reforming their health care systems to address the budgetary pressures stemming in p...
  • Brazil: Updates to Biologics Regulations Proposed

    Brazil's National Health Surveillance Agency (Anvisa) has opened a public consultation on proposed amendments (41/2012) to the regulation of biological products in Brazil.  The proposed changes, released 4 July 2012, address post-registration revisions and additions, the suspension and reactivation of registration and the cancellation of registration of biological products. A second proposal (42/2012) updates RDC Resolution 50/20, which sets forth the procedu...
  • Brazil: Anvisa Publishes New Reference Product Proposal

    Brazil's National Health Surveillance Agency (ANVISA) published a new proposed rule on medicines used as reference products for generic equivalents ( RDC No. 35/12 ) on 19 June 2012. According to the proposal, the List of Reference Medicines shall consist of three groups of drugs:  Group A for medicines that contain only one active pharmaceutical ingredient; Group B for medicines that contain two or more active ingredients in a single dosage form; and Group C fo...
  • Australia: TGA Issues Revised Medical Gases GMP Guidance

    Australia's Therapeutic Goods Administration (TGA) has issued guidance concerning the applicability of the 2009 Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co- operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products to the production of medicinal gases.  The new guidance replaces the TGA's earlier interpretation of the 2002 PIC/S GMP guidance. The revised interpretation was developed in cooperation with Australi...