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  • Regulatory NewsRegulatory News

    European Commission Consults on Revised GMPs for Sterile Drugs

    The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4 . The Commission says the revision was developed in cooperation with the World Health Organization (WHO) and the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), and is meant to add clarity to Annex 1, which has been updated numerous times si...
  • Regulatory NewsRegulatory News

    Trump Pledges to Gut FDA: Which Regulations Need to Go?

    With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house. And before this dive into what FDA might or even could do following the signing of this EO , it is important to remember a constant refrain from all experts Focus spoke with: FDA codifies stat...
  • Regulatory NewsRegulatory News

    ‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations

    President Donald Trump on Monday signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted. The order , which White House officials characterized as a “one in, two out” plan to benefit small businesses, will likely impact the US Food and Drug Administration (FDA) as it applies to every agency but those related to military or national security-related branches of the federal government or ot...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Postmarket Device Surveillance

    The US Food and Drug Administration (FDA) on Friday finalized guidance (five years after draft guidance was first released) for device manufacturers on its interpretation of the law with regard to postmarket surveillance of certain class II or class III devices. The guidance comes as the Government Accountability Office (GAO) said last October that 90% of the postmarket surveillance studies FDA ordered over the past seven years were categorized as inactive, though some...
  • Regulatory NewsRegulatory News

    FDA Warns Wearable Exoskeleton Manufacturer Over Post-Market Surveillance Failures

    Israel-based Argo Medical Technologies has been warned by the US Food and Drug Administration (FDA) after its failure to conduct post-market surveillance studies for its ReWalk device, which is meant to help individuals with spinal cord injuries to stand upright, walk, turn, and climb and descend stairs. The warning letter is for the company’s Massachusetts site, which opened in 2012, and details how the company consistently avoided FDA requests for more than a year. T...
  • Regulatory NewsRegulatory News

    Indian Parliament Proposes Extending Price Caps to all Drugs

    Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs. Background In India, the price of drugs listed as essential medicines is capped by the National Pharmaceutical Pricing Authority (NPPA) under the country's Drug Price Control Order (DPCO) . The amount these drugs can be sold for is indexed to average wholesale prices of similar products, and can only be increased once per year, as was th...
  • Regulatory NewsRegulatory News

    EMA Gives Details on New Elemental Impurity Guideline

    The European Medicines Agency (EMA) has released its recommendations for implementing a newly adopted international standard for limiting elemental impurities in drug products. Background Elemental impurities are traces of metals that can end up in finished drug products. These impurities can come from multiple points in the manufacturing process, such as residual catalysts from a product’s synthesis or from contact with manufacturing equipment, containers and other m...
  • Regulatory NewsRegulatory News

    US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

    A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends. Background The report , authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting. The first: Antibiotic resistance, which government officials blame for ...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
  • Regulatory NewsRegulatory News

    Digging Deeper into China's New Medical Device Registration Requirements

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Emergo Group colleagues in China have provided additional details on recently published changes to the China Food and Drug Administration’s (CFDA) medical device registration process. CFDA  Administrative Order No. 4  covers new and revised requirements for Class I, II and III device registrations in China that will take effec...
  • Feature ArticlesFeature Articles

    China’s Order 650 and its Impact on Medical Device Regulation

    After recent State Council reforms, the China Food and Drug Administration (CFDA) became the singular authority on medical device supervision. On 31 March 2014, the Chinese government finally released Order 650 (former Order 276), Regulations for the Supervision and Administration of Medical Devices. The order, effective 1 June 2014, sets the fundamental framework and orientation on medical device supervision and administration in China. Eighty articles determine ...
  • Regulatory NewsRegulatory News

    Final Regulation Makes it Easier for FDA to Seize Drugs at the Border

    The US Food and Drug Administration (FDA) is finalizing without change a proposed regulation introduced last year which would establish an administrative detention process for pharmaceutical products it believes are adulterated or misbranded. Background The rule is borne from the  Food and Drug Administration Safety and Innovation Act (FDASIA) , Section 709 ("Administrative Detention") of which ordered FDA to promulgate a final regulation within two years of the passage...