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Apr 30, 2017

EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017

The guideline on Trial Master File (TMF) aims to describe the requirements for TMF as covered in the new Clinical Trials Regulation (EU) No 536/2014 and ICH-GCP E6 and to assist organizations in maintaining a TMF that facilitates trial management, good-clinical-practice (GCP) compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and consecutive destruction of paper documentation.

Read the pdf

The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses

Nine months on from the 2016 European Federation of Pharmaceutical Industries and Associations (EFPIA) Disclosure Code deadline — which required all member companies across Europe to publish data concerning their 2015 transfer-of-value transactions to healthcare professionals (HCPs) — EFPIA Director of Communications Andrew Powrie-Smith offered a lively update on the responses to the Code to a highly engaged audience at last week’s CBI’s Global Transparency Reporting Congress in London.

Having monitored the media reaction to the first wave of disclosures (or attempts at disclosure), Powrie-Smith pointed to generally neutral coverage across Europe, the negative perspectives tempered largely by time constrictions on reporting before the data could be properly analysed and, in many cases, a lack of understanding about what the data actually meant. When the media commentators have had time to grasp more fully the nature of transfer-of-value disclosures and begins to drill down in more detail—focusing on individual HCPs and prescribing data, for example—Powrie-Smith said that the coverage will likely become more informed and critical.

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Summary of changes to the guidance of publication of clinical trial data by EMA
Update to the guidance published on March 03, 2016

On 03 March 2016, the European Medicines Agency published the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ (Policy 0070). Additional information that has been included in the guidance published on 12 April 2017 is outlined in the table below, including the location within the document with a summary of the additional information provided.

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Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials
FDA’s CDER and C-Path’s PRO consortium second workshop

Critical Path Institute’s (C-Path) Patient-Reported Outcome (PRO) Consortium, in collaboration with the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), was conducting a public meeting titled Second Annual Workshop on Clinical Outcome Assessments (COAs) in Cancer Clinical Trials in April. The purpose of the workshop was to provide a forum for collaborative multidisciplinary discussion to identify opportunities and address challenges for clinical outcome assessments (COAs), particularly patient-reported outcome assessments, in oncology drug development.

During this year’s workshop, a broad array of international stakeholders involved in oncology drug development and patient-reported outcome measurement provided perspectives on the role of patient-reported symptomatic adverse events in evaluating and describing the tolerability and safety of anti-cancer agents. Speakers and panelists explored the utility of information derived from existing and emerging patient-reported measures and discussed potential ways to improve the collection, analysis, and presentation of the data to support drug development and better inform treatment decisions. In addition, discussion of possible ways to assess an investigational drug’s overall side effect burden as a clinical trial endpoint was initiated. This workshop included panelists and speakers from regulatory agencies, academia, patient advocacy groups, and the medical product industry.

For the slides from the workshop, please follow the below link:

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CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline

The China Food and Drug Administration (CFDA) has amended its management guidelines for medical devices standards, reflecting measures to deepen standardization reforms issued by the State Council from March 2015. The medical devices standards management guideline was first released in 2002, and sets out both mandatory and recommended standards and technical requirements relating to the development, production, operation, use, supervision, and management of medical devices.

The amendment, which takes immediate effect, increases the number of articles in the guideline from 24 to 36. The new clauses add product-related technical requirements, while erasing the entire chapter on the formulation and review and approval of product standards, as well as some contents relating to medical device registration standards. On top of that, the document makes clear the relationship between product technical requirements and mandatory versus recommended standards, adds details relating to implementation and supervision of standards, further refines management responsibilities and revision procedures, and provides details related to standards transparency and follow-up evaluation, among others.

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