• CDSCO Releases Draft Formula for Clinical Trial Injury Compensation

    India's Central Drugs Standard Control Organization (CDSCO) has issued a call for comments on its new formula for determining compensation for patients injured in clinical trials. According to the draft, Draft Formula to Determine the Quantum of Compensation in Case of Clinical Trial Related Injury (Other Than Death) , in cases of Serious Adverse Events (SAE) other than death, the CDSCO will determine the cause of injury and decide the amount of compensation. The reg...
  • Brazil Expedites Device Imports

    Brazil's national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF) by a foreign regulator.  Under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the ...
  • EMA Set to Finalize Clinical Trials Transparency Policy

    The European Medicines Agency (EMA) announced on 8 April 2014 that it plans to launch a final round of meetings in May with organizations representing patients, academia, the pharmaceutical industry and European Union (EU) institutions before finalizing its clinical trials transparency policy.  The intent is to "fine tune" specific aspects of the policy, such as the possible redaction of the clinical study reports for those parts of clinical trial data that excep...
  • Health Canada Overhauls Product Monograph Guidance

    Health Canada issued revised product monograph  guidance  on 4 April 2014 that sets forth new design and format requirements, and also includes a new section on preparing patient information. According to Health Canada, the changes are intended to emphasize clinical relevance, make information easier to retrieve and provide format and information consistency across different drugs and drug classes. The revisions also include specific guidance for the followi...
  • China Announces Major Overhaul of Device Regulation

    On 31 March 2014, the China Food and Drug Administration (CFDA) and China's State Council Legislative Affairs Office announced the first major overhaul of the regulations governing medical devices since the system's inception in April 2000.  The end product of six years of effort, the amended Regulations on the Supervision and Administration of Medical Devices are scheduled to go into effect on 1 June 2014, with additional implementing rules to be released over...
  • TGA Proposes Warnings for OTC Oral Cough Medicines and Nasal Decongestants

    Australia's Therapeutic Goods Administration (TGA) has released for comment proposed new warnings on the label of some OTC cough medicines intended for oral use by children. The changes to the so-called Required Advisory Statements for Medicine Labels (RASML) follow recommendations made by TGA in 2012 to include warnings on products that contain the following ingredients: ammonium salts, bromhexine, dextromethorphan, dihydrocodeine, guaifenesin, ipecacuanha, phol...
  • Brazil to Require Notice One Year Prior to Drug Withdrawal

    Drug manufacturers must now provide a year's notice to Brazil's national regulator, Anvisa, prior to withdrawing a drug from the market if that withdrawal might lead to a shortage of the drug.  The objective of the new mandate, approved on 25 March 2014, is to reduce the potential impact of any drug shortage on the patient population for which the drug is indicated. The 12-month notice mandate also covers situations where the intent is merely to reduce the level...
  • Chair of UK’s MHRA Leaving

    Sir Gordon Duff, the chairman of the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced on 27 March 2014 that he is giving up his position at the agency after his recent appointment as Principal of St Hilda's College, Oxford. The move is to take place "later this year" and the Department of Health has already initiated a recruitment process to find a successor for Sir Gordon. Prior to taking the position as chair of the MHRA in January 2013, Sir Go...
  • Brazil Pushes Ahead With New Environmental Protection Plan Focused on Drug Disposal

    Brazil's Ministry of Environment (MMA) has issued a final deadline for the pharmaceutical industry to submit its own proposal on how to implement an agreement intended to ensure the environmentally sound disposal of medicines and packaging after use by consumers. The 2010 sectoral agreement requires industry to implement the mandated drug disposal measures within five years in all cities with more than 100,000 inhabitants. This is the third deadline set by the govern...
  • Brazilian Legislators Looking for Enhanced Role in Multi-Country Clinical Trials

    At a hearing on enhancing pharmaceutical research in Brazil, the chair of the Senate Social Affairs Committee, Senator Waldemir Moka, called for the creation of a working group of government agencies and academic researchers who would prepare proposals on ways to bring multi-country clinical trials to Brazil.  Another Senator, Ana Amelia, noted the possible need to revise the existing legal framework governing the conduct of clinical trials in the country, if nec...
  • CDSCO Clarifies the Role of its International Unit

    India's Central Drugs Standard Control Organization (CDSCO) has posted the organizational structure and functions of its recently-formed International Cell , which interfaces with foreign governments and regulatory agencies and investigates reports of quality concerns with India drug exports.  Among its other functions, the Cell focuses on bilateral Memoranda of Understanding (MOUs), grants written confirmations for active pharmaceutical ingredient (API) exports f...
  • New China FDA Document Clarifies Device Crackdown Plan

    On 15 March 2014, the China Food and Drug Administration (CFDA) issued a question and answer document designed to clarify the purpose of an earlier 13 March 2014 notice on the new national Special Action Program (SAP). That notice, sent to Chinese provinces and municipalities, called on local authorities to crack down on illegal activities relating to medical devices, and especially medical device registration, production, distribution and use.  The Program wi...