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    India’s CDSCO Sets up Whistleblower Reward Scheme

    India’s Central Drugs Standard Control Organisation  (CDSCO) has set up a scheme for providing monetary rewards to informers who provide specific information leading to the seizures of spurious, adulterated, misbranded and not-of-standard-quality drugs, cosmetics and medical devices. This reward scheme will be applicable to both the informers and CDSCO officers involved. The plan calls for rewards of up to 20% of the value of the products seized, to a maximum of a...
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    Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards

    This content is provided by RegLink Associates . Read all of their Breaking News alerts on their website. Anvisa Proposes Alternative Pharmacopeial Methods Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Brazilian Pharmacopoeia, with faster and better results.  The proposal complements the framework of documents t...
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    Australian Regulators Lift Ban on HIV Self-Test Kits

    Following a public consultation, Australia’s Therapeutic Goods Administration (TGA) has announced that the Secretary of the Department of Health has lifted the ban on the sale of HIV self-tests. The decision is aligned with the Seventh National HIV Strategy (2014-2017) , which aims to increase detection of HIV in the community by enabling greater access to HIV self-test kits that have been assessed for quality, safety and performance by the TGA. As a result of t...
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    India’s CDSCO Clarifies Which Devices Require Registration

    India’s Central Drugs Standard Control Organisation (CDSCO) has issued an order listing those medical device categories that are subject to the same requirements as drugs under India’s Drugs and Cosmetics Act of 1940.  Under section 3(b)(iv) of the Act, included are “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Cen...
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    India’s CDSCO Releases New Clinical Trial Guidelines

    India’s Central Drugs Standard Control Organisation (CDSCO) has released a slew of orders making a wide range of changes to the agency’s policies governing clinical trials.  New policies stated in the documents include: Sponsors, investigators, the regulator and Ethics Committees are responsible for ensuring that the design of placebo-controlled trials is appropriate, efficient and ethical; Investigators are limited to working on a maximum of three trials simultan...
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    Australia’s TGA Issues Amended Bioequivalence Guidance

    Australia’s Therapeutic Goods Administration (TGA) has issued an amended bioequivalence guidance document applicable to all prescription medicines except for biologicals.  The guidance includes European Union guidelines that have been adopted by the TGA, such as the investigation of bioequivalence, the quality of modified release dosage forms, modified release oral and transdermal dosage forms, and the clinical investigation of the pharmacokinetics of therapeutic prot...
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    Indian Regulators Say Older Fixed-Drug Combinations Can Stick Around Under New Rules

    India’s Central Drugs Standard Control Organization (CDSCO) has issued a notice exempting certain Fixed Dose Combination products (FDCs) from a requirement to submit data in support of safety and efficacy as long as they were licensed for marketing by State Licensing Authorities prior to 21 September 1988.   The 5 June 2014 decision to exempt these FDCs from the scope of the CDSCO’s 15 January 2013 mandate was based on the fact that the products were licensed bef...
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    There's an App for That: China FDA Launches Mobile Drug Regulation Application

    The China Food and Drug Administration (CFDA) has launched a "national food and drug regulation" application, or "app," that permits the user to directly access the agency’s rules, regulations, working papers, drug quality announcements, medical device quality bulletins, drug and device recall information, and press releases. The application works with iPhone and Android phone operating systems and was developed as part of what the Chinese government cal...
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    China FDA Seeks Input on Draft Regulation Tightening Control of Online Drug Sales

    The China Food and Drug Administration (CFDA) has released for public consultation a draft regulation that would tighten control of online sales of food and drugs. The rule will drug prohibit producers and wholesalers to sell products to online consumers, and will require sellers of food, health food, cosmetics, and medical apparatus and instruments to obtain permits. CFDA will crack down on false advertising, and information about certain drugs, including stu...
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    Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics

    Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs.  So-called "dynamized" drugs in Brazil are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.  Specific drugs are products that do not fit int...
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    India Issues Final Rule on Compensating Clinical Trial Deaths

    India’s Central Drugs Standard Control Organization (CDSCO) has released amended rules specifying the formula and the process that will be used for determining the amount of compensation to be paid by clinical trial sponsors for the death of a clinical trial research subject.  Under the amended rules, which took effect on 30 May 2014, an Independent Expert Committee will examine the report of the death and make a recommendation within 30 days to the CDSCO as to t...
  • Brazilian Pharma Sector Submits Drug Waste Proposals

    After several extensions of the deadline by the Brazilian government, the Brazilian pharmaceutical sector has finally submitted three suggestions to the Ministry of Environment for a pharmaceutical sectoral agreement on the disposal of medicines by consumers  . After review by the Ministry, a final proposal will be submitted for consideration to the Steering Committee for the Implementation of Reverse Logistics Systems (CORI), which is coordinated by the Ministry ...