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Mar 2, 2020

New Address for Widler & Schiemann AG in Zug
From 1 March 2020, the company Widler & Schiemamm AG has new address: Baarerstrasse 75, 6300 Zug

EFPIA CDEG position paper on
the use of Form FDA 1572 for clinical trials performed outside the USA

The EFPIA Clinical Development Expert Group (CDEG) published the position paper providing recommendations on the use of Form FDA 1572 for non-IND sites.

In 2018/2019 the EFPIA Clinical Development Expert Group (CDEG) conducted a survey amongst its member organizations to evaluate the potential impact of the non-acceptance of Form FDA 1572 ex-US by EU Member States. The outcome of this survey showed that standard practices regarding the use of Form FDA 1572 in the EU (or other countries outside US) is not consistent across companies and there seems to be a need to provide clarity and recommendations when the FDA form is rejected by EU national Health Authorities, which could cause undue delay in starting a clinical trial.

Therefore, this position paper provides recommendations as to when a Form FDA 1572 should be used in a clinical trial and when it should not. Three options have been identified, for which the pros & cons are detailed in this position paper.

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Orphan medicines in the EU
On 28 February 2020 the EMA published the leaflet on orphan medicines in the EU.

The EU offers incentives to encourage companies to research and develop medicines for rare diseases that otherwise would not be developed. To access these incentives, companies can apply for orphan designation for their medicine, provided certain criteria are met.

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Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
On 21 February 2020 the FDA announced the availability of the final guidance for industry.

FDA has identified certain submission types that warrant an exemption (Type III drug master files (DMFs)) or a long-term waiver (certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications) from the requirement to submit to the Agency in electronic common technical document (eCTD) format. In addition, this guidance outlines certain circumstances where FDA may determine that a short-term waiver from eCTD submission requirements could be granted. This guidance finalizes the revised draft guidance of the same title issued in July 2019 and replaces the final guidance issued in January 2019 (Revision 6).

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Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
On 19 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 20 April 2020.

This guidance expands upon, consolidates, and supplements the recommendations on nonclinical immune system assessments provided across multiple guidance documents, most notably the ICH guidance for industry “S8 Immunotoxicity Studies for Human Pharmaceuticals.” The topics covered include various aspects of immune suppression, modulation, and stimulation. This guidance replaces the withdrawn guidance entitled “Immunotoxicology Evaluation of Investigational New Drugs.”

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Good manufacturing practice
On 19 February 2020 the EMA updated the GMP guidelines.

The European Commission is holding a second targeted stakeholder consultation on the updated draft Annex 1 of the EU GMP guidelines on manufacturing of sterile medicinal products. This focuses on significant modifications since the first consultation in early 2018 and aims to gather stakeholders' feedback on certain manufacturing steps.

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European Medicines Agency’s Privacy Statement
On 19 February 2020 the EMA published its privacy statement for the pre-employment medical examination.

This Privacy Statement explains the most essential details of the processing of personal data by the EMA in the context of the pre-employment medical examination.

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ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals
On 18 February 2020 the EMA published the Step 5 on ICH S5 (R3) guideline on reproductive toxicology.

The purpose of this revision document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART) testing required to support human clinical trials and marketing authorization for pharmaceuticals. The guideline describes potential strategies and study designs to supplement available data to identify, assess, and convey risk. General concepts and recommendations are also provided that should be considered when interpreting study data.

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ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
On 18 February 2020 the EMA published the Step 5 on ICH E9 (R1) addendum on estimands and sensitivity in clinical trials.

This addendum presents a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis and interpretation, as well as between sponsor and regulator regarding the treatment effect(s) of interest that a clinical trial should address.

The principles outlined in this addendum are relevant whenever a treatment effect is estimated, or a hypothesis related to a treatment effect is tested, whether related to efficacy or safety. While the main focus is on randomised clinical trials, the principles are also applicable for single arm trials and observational studies. The framework applies to any data type, including longitudinal, time-to-first event, and recurrent event data. Regulatory interest in the application of the principles outlined will be greater for confirmatory clinical trials and, where used to generate confirmatory conclusions, for data integrated across trials.

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Widler & Schiemann AG - Weinberghöhe 10 B - CH 6300 Zug, Switzerland - VAT number: CHE-472.215.777 MWST - Public Limited Company according to Swiss Common Law - Managing Partner: Dr. Beat Widler, Dr. Peter Schiemann - +41 41 558 9193 - -