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  • Regulatory NewsRegulatory News

    EMA offers new Q&A on data monitoring committees

    The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.   EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.   “The ultimate responsibility for a clinical trial re...
  • Regulatory NewsRegulatory News

    Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance

    Pfizer and Bristol-Myers Squibb (BMS) recently raised questions with and sought further clarity from the US Food and Drug Administration (FDA) on a draft guidance related to the risk-based monitoring (RBM) of clinical trials. The eight-page RBM draft guidance , released in March, comes in the form of eight questions and answers. It expands on guidance from August 2013, known as “ Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring ,” by providing...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia . CFDA Posts Draft Medical Device Adverse Event Monitoring Guidance China’s Food and Drug Administration (CFDA) has posted draft guidance on post-marketing supervision of medical devices. The guidance sets out the role regional and national regulators, medical device manufacturers and adverse event monitoring technology institutions will play in tracking the safety of...
  • Regulatory NewsRegulatory News

    FDA Finalizes Two Guidance Documents on Blood Glucose Monitoring Systems

    • 07 October 2016
    The Food and Drug Administration (FDA) on Friday finalized two guidance documents related to blood glucose monitoring systems (BGMSs), offering new recommendations on the different types of information in 510(k)s for BGMSs used by health professionals versus SMBGs intended for home use by lay users. FDA says the guidance was necessary as it has become increasingly clear that these different use settings have distinct intended use populations with unique characteristics...
  • Feature ArticlesFeature Articles

    The New KYSS Principle: Know Your Supplier's Supplier

    • 27 May 2016
    This article introduces the KYSS principle to align a robust supplier management program with regulatory requirements and includes initial identification and qualification of suppliers, supplier quality agreements and both initial and ongoing supplier monitoring. Introduction Deaths, illnesses, injuries and many recalls have been attributed to fraudulent, counterfeit or adulterated components of finished pharmaceuticals and medical devices. 1 These tragic consequence...
  • Regulatory NewsRegulatory News

    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
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    Asia Regulatory Roundup: CFDA Consults on Good Supply Practices, Traceability (23 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Reviews Good Supply Practices After Suspending Ali Health-run Platform The China Food and Drug Administration (CFDA) has begun a consultation on good supply practices and traceability after suspending the use of a drug monitoring system run by Alibaba-subsidiary Ali Health. In revising its traceability document, CFDA has removed references specific to the electro...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Pharmacy Sues CFDA Over Drug Monitoring System (2 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pharmacy Sues CFDA Over Alibaba Electronic Drug Monitoring System Yontinhe Group has filed a lawsuit against the China Food and Drug Administration (CFDA). The case relates to an electronic drug monitoring system that CFDA introduced in 2013 in collaboration with a subsidiary of the Chinese tech giant Alibaba. CFDA and Ali Health, the Alibaba subsidiary, purportedly ...
  • Regulatory NewsRegulatory News

    Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

    A critic of Canada's Protecting Canadians from Unsafe Drugs Act —commonly known as Vanessa's Law —argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety. Background Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's d...
  • Regulatory NewsRegulatory News

    New Drug Safety Monitoring Fees Come Into Effect in Europe

    User fees paid by pharmaceutical companies, intended to fund regulatory activities by offsetting their expense, are set to rise in Europe under a new regulation published this week. The fees are intended to pay for new pharmacovigilance activities—basically the monitoring of medicines after their initial approval—that were required under legislation passed in 2010 and amended in 2012. The law, known as the pharmacovigilance legislation , is intended to centrali...
  • New FDA Guidance Calls for Increased Emphasis on Centralized Trial Monitoring

    A new guidance document released by the US Food and Drug Administration on 6 August 2013 calls on sponsors to develop centralized risk-based monitoring strategies for clinical trials involving medical products with the ultimate goal of enhancing protections for human subjects while simultaneously improving the quality of clinical trial data. Background The guidance, Oversight of Clinical Investigations, A Risk-Based Approach to Monitoring , isn't focused on any one...
  • China Announces Electronic Monitoring Deadlines for Imported Drugs

    The China Food and Drug Administration (CFDA) has issued a notice setting deadlines for implementing electronic monitoring for imported essential drugs. Imported drugs in domestic packaging must comply with electronic monitoring requirements by the end of November 2013, and all other imported drugs by the end of March 2014. The implementation of electronic monitoring is to be done in accordance with the former State Food and Drug Administration notice "on the issuance...