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Nov 30, 2016

ICH adopts E6 R2
The International Council on Harmonisation adopts the addendum to its E6 guideline

This might be probably old news for most of you, but we believe it is worth mentioning again:

“The 1996 ICH guideline on GCP is one of the most significant achievements of the ICH process, establishing harmonised standards for clinical trials. The ICH Assembly adopted an important amendment (ICH E6(R2)) that aims to encourage sponsors to implement improved oversight and management of clinical trials, while continuing to ensure protection of human subjects participating in trials and clinical trial data integrity. This amendment will now be implemented by ICH members through national and regional guidance.”

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Dieter Russmann, MD, joins Widler & Schiemann
After a career that lasted more than 25 years, Dieter Russmann joins Widler & Schiemann

Dieter is a board certified urologist with sound expertise in urology, nephrology, general surgery, oncology, gastro-enterology and clinical pharmacology. His industrial background includes serving as advisor to companies and health ministries, as well as leading scientific boards. His expertise in generics and biosimilars is unique. He has a deep knowledge in drug and device development, regulatory strategy, drug safety, and is an experienced GCP auditor. Dieter is a proven business developer, with an extensive network in industry and academia, payers and politics.

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Non-Inferiority Clinical Trials to Establish Effectiveness
FDA publishes new guidance for industry

This is a very useful guidance document on “non-inferiority” trials with an excellent (and concise) background section on the topic. As per the FDA’s opening statement (see below), the document provides guidance with regard to non-inferiority study designs as applied to efficacy. It also makes a distinction between non-inferiority trials and equivalence trails.

“This document provides guidance to sponsors and applicants submitting investigational drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic, usually because a superiority study design (drug versus placebo, dose response, or superiority to an active drug) cannot be used. 2 The guidance gives advice on when NI studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. This guidance does not provide recommendations for the use of NI study designs to evaluate the safety of a drug.”

“This guidance finalizes the draft guidance for industry, Non-Inferiority Clinical Trials, published in 2010. In addition, it supersedes the guidance for industry, Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval, also published in 2010, which will be withdrawn.”

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EMA revises the Guideline on First-in-Human Clinical Trials
Comments are invited until end of February 2017

The European Medicines Agency (EMA), in cooperation with the European Commission and the Member States of the European Union (EU), is proposing changes to its existing guideline on first-in-human clinical trials, to further improve the safety of trial participants. The revised guideline is open for public consultation until 28 February 2017. Comments should be sent to using the template provided. (...) EMA’s existing guideline, released in 2007, provides advice on first-in-human clinical trials, in particular on the data needed to enable their appropriate design and allow the initiation of treatment in trial participants.

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Consultation on EU Pediatric Regulation
The European Commission launches a public consultation on the Pediatric Regulation

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly ten years of implementation. The consultation is open until 20 February 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

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CFDA issues Q&A on generics QE consistency reviews
The China Food and Drug Administration issues a Q&A document to facilitate understanding of their recently published new BE guidance on Quality and Efficacy

The China Food and Drug Administration (CFDA) has issued an unusual statement to its website setting out 15 questions and answers related to this year's introduction of the requirement for generics to prove quality and efficacy (QE) consistency with originator drugs.

The publication of the document gives some indication of the pressures that this year's new requirements have entailed for domestic companies. Key questions addressed within the document include:

  • How to decide on a suitable reference preparation (RP) when there are difficulties identifying the originator drug, or it has ceased manufacturing or is now unlisted in the United States or Japan
  • When originator drugs cannot be purchased or are otherwise unavailable, the CFDA advises firms to carry out a clinical effectiveness study
  • When will the RP catalogue and selected exempt varieties be published
  • Are there different QE consistency procedures/review processes for drugs from the essential drug catalogue? (Answer: no)
  • Can the CFDA publish consistency review statistics regarding all companies in a timely manner, to improve industry efficiency and allow monitoring of product review progress? (Answer: the CFDA promises to release such details imminently)
  • Can companies not based in one of the Marketing Authorization Holder (MAH) pilot scheme regions participate in the MAH pilot scheme if they have a product that has proven QE consistency with an originator? (Answer: not without a change to the Drug Administration Law).

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