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Mar 31, 2018

Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report

During the past decade, site identification, site selection, and study start-up— collectively referred to as the study initiation process—have become priority improvement areas in the conduct of clinical trials. Despite implementation of new technology solutions and practices, the study initiation process remains highly inefficient with wide variation between companies.

This report summarizes key findings of a recent Tufts CSDD study, based on a global survey, the first to comprehensively benchmark site identification, site selection, and start-up cycle times for both repeat and new investigative sites for Phase II and III clinical studies. The findings indicate that the site initiation process has become increasingly challenging for sponsors and CROs looking to identify and engage more specialized investigators and patient sub-populations worldwide.

This article can be purchased through a subscription from the Center for the Study of Drug Development at Tufts University School of Medicine, Boston, USA.

CHMP adopts new Guideline on Good Pharmacogenomic Practice
The new guideline adopted by the CHMP will become effective on 1st September 2018

Genomic data have become important in the evaluation of efficacy and safety of medicinal products for regulatory approval. Genomic information in the product information (PI) influences patient treatment decisions. Therefore, use of genomic biomarkers in drug development, should, in order to be of value, follow certain principles which are outlined in this guideline.

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Some methodological issues with respect to genomic clinical study design highlighted in this guidance is complementary to the what is described in the Reflection paper on methodological issues associated with pharmacogenomic biomarkers in relation to clinical development and patient selection (see section 3).

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China’s NHFPC and CFDA to be downgraded amid ministerial reshuffle
The National People’s Congress officially approved plans for a ministry shakeup

The National People’s Congress officially approved plans for a ministry shakeup that will change the landscape of health regulation in China. Amid a reduction in the number of state-level ministries, vice-ministries, and commissions, both the China Food and Drug Administration (CFDA) and National Health and Family Planning Commission (NHFPC) are set to be dissolved.

Functions previously performed by the CFDA and NHFPC will be subsumed within two new super-ministries: drug administration will be carried out by a second-tier ministry under the National Market Supervision Administration (NMSA; no official translation/abbreviation available currently). The NMSA is also set to take on duties previously managed by the State Administration for Industry and Commerce, General Administration of Quality Supervision, Inspection and Quarantine, and the National Development and Reform Commission (NDRC)’s Price Supervision, Inspection and Antitrust Bureau. The NHFPC’s functions will chiefly be carried out by a new National Medical and Health Commission (NMHC). A dedicated National Medical Insurance Ministry will also be established, rationalizing management of China’s national insurance schemes under one roof.

Full details of the reshuffle will emerge in coming weeks, with new appointments beginning to be made. While day-to-day drug administration is likely to continue with little disruption, the demotion of the CFDA to a second-tier unit creates much uncertainty for companies operating in the market, the agency having played a leading role in pushing forward reforms to encourage drug innovation and accelerate market approval timelines. Source: GBI (

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USFDA’s Compliance Policy for Combination Product Post-Marketing Safety Reporting
Immediately in Effect Guidance for Industry and Food and Drug Administration Staff

This guidance document is intended to assist Combination Product Applicants who are subject to the Combination Product Post-Marketing Safety Reporting Final Rule (hereafter “combination product PMSR final rule,” “final rule,” or “rule”), issued on December 20, 2016 (81 FR 92603), and codified in 21 CFR Part 4, Subpart B. This guidance document discusses FDA’s compliance policy for the rule. FDA does not intend to enforce certain requirements under the rule, specifically 21 CFR 4.102(c) and (d), 4.104(b)(1) and (b)(2), and 4.105(b), for a period of time as discussed further in section III below. FDA intends to delay enforcement of these provisions to ensure that Combination Product Applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with these requirements, and in doing so, have sufficient time to consider the recommendations and technical specifications that FDA intends to provide through guidance to support compliance. For all other provisions of 21 CFR Part 4, Subpart B, FDA intends to enforce (or continue enforcing) the requirements per its usual policies as of the compliance date provided in the final rule.

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New tracking tool for EMA’s relocation to Amsterdam
Tool gives transparent overview of main milestones and work stream deliverables

The European Medicines Agency (EMA) has published a new tool showing the main milestones and deliverables for the Agency’s move to Amsterdam.

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