• Regulatory NewsRegulatory News

    Quantitative Benefit-Risk Assessment: FDA Officials Detail Key Considerations

    The US Food and Drug Administration (FDA) is preparing to advance the use of structured benefit-risk assessments in its decision making under its commitments in the recently reauthorized Prescription Drug User Fee Act (PDUFA VI), and agency officials on Monday laid out key considerations for sponsors. Background In 2009, FDA began work to develop a structured approach to conducting benefit-risk assessments as part of an effort to bring more clarity and consistency t...
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    EMA Opens Consultations of Two Revised ICH Guidelines

    The European Medicines Agency (EMA) on Thursday released for consultation a revised ICH guideline on reproductive toxicology and an addendum to another guideline on statistical principles for clinical trials. Draft ICH E9 (R1) The 23-page addendum, which is open for comments through 28 February 2018, clarifies and extends ICH E9. While noting that it “remains undisputed that randomisation is a cornerstone of controlled clinical trials and that analysis should aim...
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    ICH Details Pilot Training Programs for 2017

    The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan. The training programs are part of a pilot initiative agreed to at ICH's management committee meeting in Osaka, Japan in November 2016, where members of the management committee launched the year-long pilot and set out criteria for the program. Under the pilot, the ICH Training Subcommittee has partnered with a small group of training p...
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    ICH Releases Concept Paper for Planned Guideline on Collecting Safety Data

    The International Conference for Harmonization (ICH) on Wednesday released the concept paper and business plan for its upcoming guideline on targeted approaches to safety data collection. ICH says the goal of the guideline, referred to as ICH E19, will be to provide "harmonized guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemen...
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    European Regulatory Roundup: Swissmedic Proposes Overhaul of Drug Ordinances (29 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Swissmedic Proposes Overhaul of Drug Ordinances to Simplify Authorizations The Swiss Agency for Therapeutic Products (Swissmedic) is rewriting its ordinances to simplify the authorization of drugs in certain situations. Swissmedic embarked on the comprehensive overhaul of the regulations in response to changes to the Therapeutic Products Act that were finalized last ye...
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    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
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    ICH Expands MedDRA's Uptake Globally

    The International Council for Harmonization (ICH) on Monday touted the global expansion of its Medical Dictionary for Regulatory Activities (MedDRA) and provided updates on other activities related to MedDRA. According to ICH, MedDRA is now used by more than 5,000 subscribers in 103 countries. "This reflects the successful adoption of MedDRA as a worldwide standard in the protection of public health," ICH said following MedDRA's management board meeting in Montreal last...
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    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
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    EMA’s Pediatric Committee Seeks to Tweak ICH Q&A on Nonclinical Evaluation of Cancer Drugs

    The European Medicines Agency’s (EMA) Pediatric Committee has offered a couple of comments, slight tweaks and further suggestions for the International Council for Harmonisation’s (ICH) draft question and answer document on its S9 guideline on the nonclinical evaluation for anticancer pharmaceuticals. The committee points to a couple of references in the Q&A on S9 on the scope of the guideline and the statement that "the need for juvenile toxicity testing sho...
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    ICH Offers Reflection Paper on Good Clinical Practice Revisions

    The International Council for Harmonisation (ICH) on Thursday opened for comment a new reflection paper on Good Clinical Practice (GCP), part of a plan to modernize ICH guidelines on clinical trial design, planning, management and conduct. The scope of the revisions includes the current E8 General Considerations for Clinical Trials and further revision to the E6 Guideline for Good Clinical Practice , which is already undergoing modernization with the recent de...
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    Japan Joins International API Manufacturing Inspection Program

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs). “PMDA has decided to join this program from 24 November 2016,” the agency said in an announcement. “The participation in...
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    ICH Advances Three Guidance Documents

    The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase. On the Step 4 front, the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced. “The current amendment (ICH E6(R...