• ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join

    While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future. Paul Hargreaves, chair of PIC/S, explained to attendees at the P...
  • Regulatory NewsRegulatory News

    Medical Device Industry, FDA Forge Nearly $1B Reauthorization of User Fee Program

    The US Food and Drug Administration (FDA) and medical device industry have agreed in principle to a new user fee program that will see the agency collect $999.5 million in user fees, which is more than $400 million more than the five-year user fee program set to expire in 2017. Under the new draft agreement, which is part of the fourth reauthorization of  the Medical Device User Fee Agreement, FDA would use the funds for a whole host of new programs, including the add...
  • Regulatory NewsRegulatory News

    MHRA Cites Pharmaceutics International for GMP Issues at Two US Sites

    The Medicines and Health Care products Regulatory Agency (MHRA) on Wednesday cited US-based contract manufacturing organization Pharmaceutics International, Inc. (Pii) for critical deficiencies at two of its Maryland facilities. In the reports, outlined in two separate statements of non-compliance published to the European Medicine Agency's (EMA) EurdraGMP database, the inspectors say they identified a "failure of organizational and technical measures to minimize the ris...
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    ICH Genomic Sampling Guidance: FDA Begins Consultation

    The US Food and Drug Administration (FDA) on Thursday launched a two-month public consultation for input on a recently drafted International Conference for Harmonization (ICH) guideline on genomic sampling. Specifically, the guideline, E18 Genomic Sampling and Management of Genomic Data , seeks to create uniform standards for collecting, storing and handling genomic samples used in clinical trials. According to ICH, the guideline "will clarify points to consider ...
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    Updated: RAPS Seeks Authors for International Fundamentals of Regulatory Affairs Book

    • 05 May 2016
    RAPS will be publishing the third edition of Fundamentals of International Regulatory Affairs later this year. We are looking for authors for chapters on general information, pharmaceuticals, biologics and other product types. All medical device chapters have been assigned. Outlines will be due 15 June 2016 and chapters will be due 1 September. If you are interested in participating in this project, please send your CV and the chapter(s) of interest to Pam Jones ...
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    IMDRF Offers Progress Updates at March Meeting

    The ninth meeting of the management committee of the International Medical Device Regulators Forum (IMDRF) took place in Brasília, Brazil, from 8 to 10 March 2016 and included high-level updates on how the group’s seven current work items are progressing and how device regulations are continuing to converge at the international level. Background Originally launched as the Global Harmonization Task Force (GHTF) in 2012, the IMDRF is composed of regulators from Australia,...
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    WHO Declares Public Health Emergency Over Microcephaly, Zika Suspected as Cause

    The World Health Organization (WHO) on Monday declared a public health emergency in response to clusters of microcephaly and Guillain-Barré Syndrome (GBS) in Brazil and French Polynesia suspected to be caused by the Zika virus. "I am now declaring that the recent clusters of microcephaly and other neurological abnormalities reported in Latin America, following a similar cluster reported in French Polynesia in 2014 constitutes a Public Health Emergency of International Co...
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    What's in a Name? Nonproprietary Naming of Biological Products

    This article discusses recently published FDA draft guidance on Nonproprietary Naming of Biological Products. What's in a name? Well, everything, since it provides a unique identity. A name may not be important to Romeo and Juliet, but it truly matters when it comes to regulation of biological products. On 27 August 2015, FDA published its long-awaited and much-anticipated draft guidance, Nonproprietary Naming of Biological Products . 1 The draft guidance describes F...
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    Bringing Structure to Substance Information

    This article discusses compliance challenges pharmaceutical companies face with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standard for structured substance information. To support continuous pharmacovigilance oversight improvement within the EU, the European Commission has mandated pharmaceutical companies’ adherence to ISO IDMP standards by 1 July 2016 . 1 These standards collectively outline the data ...
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    Keeping an Eye on Corporate Integrity Agreements

    Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.   The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com Even in the world of healthcare product regulation, the initials CIA sti...
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    Evolution of Board Responsibility for Compliance Program Oversight

    Will the Pfizer Class Action be the Missing Link? This article examines how OIG's expectations of the role played by a company's Board of Directors in overseeing corporate compliance programs have changed over time in a manner corresponding to Audit Committee requirements of Sarbanes-Oxley. In March 2015, a US district court tentatively approved the settlement of a class action lawsuit filed against Pfizer Inc., in connection with the off-label promotion of a number...
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    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...