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Mar 1, 2017

US Government publishes revision for the protection of human subjects
Widler & Schiemann’s interpretation of the new policy

“The departments and agencies listed in this document announce revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. These revisions are an effort to modernize, simplify, and enhance the current system of oversight.”

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ICH invites comments on Efficacy Guidelines
ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6

ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. The scope of the proposed renovation 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 production of ICH E6(R2).

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EMA invites comment on revised “Document Access Policy”
Comments from stakeholders invited until 18 May 2017

The European Medicines Agency (EMA) launches today a public consultation on the proposed revision to its policy on access to documents. The policy describes the rules EMA applies to grant access to the documents that it holds, in accordance with Regulation (EC) No 1049/2001External link icon, which gives citizens a right to access EU documents.

The revision is based on EMA’s experience with the original policy introduced in 2010. The new version extends the scope of the policy to include explicitly corporate documents and takes into account the Agency’s proactive approach to transparency that has led to the publication of many more documents on the EMA website since 2010.

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Over 1,000 studies now recorded in EU register of post-authorisation studies
EU PAS Register increases transparency of research in medicines after they have been authorised in the EU

The 1,000th study has been uploaded in the European Union (EU) electronic Register of Post-Authorisation Studies (EU PAS RegisterExternal link icon).

The EU PAS Register provides a wealth of information on the safety and effectiveness of authorised medicines. It is an openly accessible platform with information on post authorisation research in medicines already marketed in Europe and includes study protocols, study results, related publications and other relevant information.

The information in the EU PAS Register reduces publication bias[i] through increased transparency of medicines research, improves the quality of post-authorisation studies by facilitating peer-review of protocols and results, facilitates collaboration among stakeholders, and ensures compliance with EU pharmacovigilance legislation requirements.

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FDA publishes OSI Statistics
OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage

The slides provided as PDF download file show the annual inspection metrics for compliance overseen by the OSI, OSIS, CDER.

The data stem directly from CDER’s database “Complis” and other sources as noted in the PDF.

The slides show a very interesting increase in inspections focusing on Bioequivalence studies.

Also notable is that the majority of the findings at investigational sites results from protocol non-compliances.

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CFDA sets out principles for generic equivalency clinical trials
Follow up to last years’ release of new Bioequivalence guidelines

The China Food and Drug Administration (CFDA) this week released the latest guidance related to last year's new generic bioequivalence standards. As set out in the notification (No. 18), guidelines released last year established that in principle generic drugs should undergo in vivo bioequivalence to establish equivalency with originator drugs. This release is specifically designed to set out principles for companies that cannot find or determine a suitable reference preparation for such tests, and are therefore required to undergo clinical trials to establish their drug's efficacy.

The paper makes a detailed analysis of five aspects, including preliminary judgment of clinical efficacy, comparison drug, types of comparison, trial endpoints and patient enrollment numbers. Generic drugs undergoing clinical efficacy trials should be considered in terms of efficacy compared with other therapies, taking into account the presence or absence of other factors influencing the efficacy of existing therapies. The document encourages demonstration of superiority over a positive control drug. In addition, the document states that appropriate endpoint selection and patient enrollment targets can be determined with reference to existing guidelines for drug clinical trials. Please refer to the reference source for full details.

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