RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    TGA Weighs Rescheduling Codeine Following Safety Review

    Codeine-containing medicines may soon be available by prescription only in Australia, following a review and public consultation by the Therapeutic Goods Administration (TGA). Background In Australia, as in many other countries, medicines and other chemicals are classified in a schedule based on the level of regulatory control required for different substances according to their safety and use. Drug Schedules in Australia Schedule 1 Not currently in use Sched...
  • Regulatory NewsRegulatory News

    Australia Releases Updated Drug Schedule

    Australia has updated a legislative instrument designed to advise the country's states and territories on the scheduling and labeling of medicines and poisons. Background In Australia, like in many other countries, medicines and other chemicals are classified in a schedule system. The schedule is organized by the level of regulatory control required for different substances based on their safety and use. The legal basis for drug scheduling in Australia is found in ...
  • Regulatory NewsRegulatory News

    FDA Recommends Use of LOINC Data Standard

    The US Food and Drug Administration (FDA) is recommending the use of an existing data exchange standard for nearly all pharmaceutical and biological submissions. Background The agency, through its Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), has decided to adopt the Logical Observation Identifiers Names and Codes (LOINC) as "part of a larger FDA effort to align the use of data standards for clinical research with ongoing ...
  • FDA Looks to Establish Standardized, Mandatory Labeling Format for Medical Devices

    The US Food and Drug Administration (FDA) is preparing to hold a public meeting during-and before-which it plans to solicit comments on how to standardize the labeling found on medical device products in a way more similar to that of pharmaceutical products. At present, there are no regulations defining a standardized approach for how content should be structured or formatted on a medical device. This is considerably different than other FDA-regulated products, such as f...
  • USP Standard Aims to Reduce Medication Errors through Standardized Labeling

    The US Pharmacopoeia (USP) has announced a new "universal" standard for the content and appearance of prescription container labels, a response to what it says is a surge of medicate misuse resulting in part from non-standard and confusing labeling formats. "Wide variability in prescription container labels exists today across individual prescriptions, pharmacies, retail chains and states," USP explained. The new standard, it said, will provide guidance based on resear...
  • ISO Releases New Voluntary Anti-Counterfeiting Standard

    The International Standards Organization (ISO), whose standards are commonly used by the life sciences industry, has released a new standard to allow for uniform authentication standards to combat counterfeit goods, including medicines and medical devices. The standard, ISO 12931: 2012 - Performance criteria for authentication solutions used to combat counterfeiting of material goods , discusses several "authentication solutions," including holograms, tags, and m...
  • New ISO Standard Released for Characterizing Nanoparticles

    The International Standards Organization (ISO), an international body whose standards are often used by regulatory authorities, has unveiled new guidance on conducting toxicology tests on nanomaterials. ISO's 3 July 2012 technical report, "Nanotechnologies - Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment" (ISO/TR 13014:2012) is intended to be used to help researchers understand a nanomaterial's physicochemical ...
  • Brazil: New Bioanalytical Standard Published

    Brazil's national regulatory agency, Anvisa, has published a new standard ( RDC 27/2012 ) setting forth the minimum requirements for conducting the bioanalytical method validation studies needed for the registration of medicines. The new requirements take effect as of 1 December 2012 and will replace several provisions of Resolution 899/2003 on bioanalytical methods.  Industry may file documentation with Anvisa in accordance with the old standard or use the exist...
  • USP Plans to Launch Updated Heparin Standard to Ensure Safety

    • 23 May 2012
    The US Pharmacopoeia (USP) is announcing the impending launch of an updated standard meant to further boost the safety and quality of Herparin, contaminated supplies of which were associated with numerous deaths in 2007 and 2008.  "The third and latest round of revisions to USP's heparin standards will bring even greater sensitivity and precision to the tests and reference materials used to help ensure heparin quality," said USP in a statement. "In response to reque...
  • Report: FDA Meeting Review Goals Under PDUFA

    The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA) . GAO's report to Congress notes FDA has generally "met performance goals for priority and standard New Drug Applications (NDAs) and Biologic License Applications (BLAs) recei...
  • ISO Releases New Device Standard for Toothbrushes

    The International Organization for Standardization (ISO) has released a new standard for a common medical device: the toothbrush. In ISO 20126:2012, Dentistry-Manual Toothbrushes-General Requirements and Test Methods , the organization outlines "pass-fail criteria, physical inspection guidelines, fatigue resistance, chemical challenge and handle strength requirements and tests, as well as marking, labeling and packaging guidelines for manual toothbrushes." "[C]omm...
  • What's in a Frame? ISO Releases New Standard for Glasses Frames

    The International Standards Organization (ISO) released a new standard for glasses frames, saying a new standard was needed to "ensure that glasses manufactured everywhere in the world are safe to use" and adhere to "fundamental requirements." ISO's standard, ISO 12870:2012,  Ophthalmic optics - Spectacle frames - Requirements and test methods , includes outlined requirements for: physiological compatibility measurement dimensional tolerances tolerance on scr...