Male Breast Cancer: Developing Drugs for Treatment
On 12 August 2020 the FDA announced the availability of the guidance for industry.
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Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
On 12 August 2020 the FDA announced the availability of the guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.
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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use
On 21 July 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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EMA Updated EudraVigilance Registration Manual
On 21 July 2020 the EMA announced the availability of the updated EudraVigilance registration manual.
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MHRA Planning for Return to On-site Good Practice (GxP) Inspections
On 23 July 2020 it was published on the MHRA Inspectorate Blog that MHRA is planning for return to on-site GxP inspections.
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Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
On 29 July 2020 the FDA issued the final guidance for industry.
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Multiple Function Device Products: Policy and Considerations
On 29 July 2020 the FDA issued the final guidance for industry and FDA staff.
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MHRA Updated Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol
On 31 July 2020 the UK MHRA announced the availability of the updated guidance.
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Global Regulatory Workshop on COVID-19 Therapeutics #2: Agreement on Acceptable Endpoints for Clinical Trials
On 31 July 2020 the international regulators published a report on the acceptability of various primary endpoints in the clinical trials conducted for the development of treatments for COVID-19.
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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
On 1 July 2020 the FDA issued the immediately in effect guidance for industry and FDA staff.
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Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 2 July 2020 the FDA updated the final guidance for industry, investigators and IRBs.
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Annual Report of the Pharmacovigilance Inspectors Working Group for 2018
On 2 July 2020 the EMA announced the availability of the 2018 PV annual report.
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Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 3 July 2020 the EMA published revision 8 of the guidance for sponsors.
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Technical Notice to Sponsors Regarding Continuous Compliance with the EU Legislation for Clinical Trials Following the Withdrawal of the United Kingdom from the EU
On 9 July 2020 a joint technical notice to sponsors by the European Commission, EMA and HMA was published.
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Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients
On 10 July 2020 the FDA announced the availability of the final guidance for industry and IRBs.
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China NMPA Guidance on the Management of Clinical Trials of Medical Products During COVID-19 Pandemic
On 14 July 2020 the Chine NMPA issued the draft guidance in Chinese for sponsors and investigators.
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Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
On 15 July 2020 the FDA issued the final guidance for industry and FDA staff.
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Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
On 16 June 2020 the FDA announced the availability of the final guidance for industry, FDA staff, and other stakeholders.
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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency
On 17 June 2020 the FDA announced the availability of the final guidance for industry.
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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing
On 19 June 2020 the FDA announced the availability of the final guidance for industry.
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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers
On 22 June 2020 the FDA published the final guidance on the Q&A for industry and FDA staff.
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Review and Update of Device Establishment Inspection Processes and Standards
On 26 June 2020 the FDA announced the availability of the final guidance for industry.
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Risk Evaluation and Mitigation Strategies: Modifications and Revisions
On 29 June 2020 the FDA announced the availability of the final guidance for industry.
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Points to Consider on Implications of Coronavirus Disease (COVID-19) on Methodological Aspects of Ongoing Clinical Trials
On 29 June 2020 the EMA announced the availability of this guidance.
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Pharmacovigilance Inspection Program Risk Assessment Survey
On 30 June 2020 the Australian TGA announced that the PVIP Risk Assessment Survey is open for medicine sponsors to complete.
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Widler & Schiemann GmbH Germany Goes Live with Dr. Andreas Fischer, Managing Director
On 1 July 2020 Widler & Schiemann AG Announced New German Subsidiary.
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Questions and Answers: Qualification of Digital Technology-based Methodologies to Support Approval of Medicinal Products
On 1 June 2020 the EMA updated the Q&A document on the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.
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Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators
On 2 June 2020 the FDA announced the availability of this guidance for IRBs and clinical investigators.
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FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
On 2 June 2020 the EMA and FDA published the joint document for medicine developers planning to submit an iPSP and PIP.
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Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 5 June 2020 the FDA announced the availability of this guidance for industry and FDA administration staff.
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Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency
On 8 June 2020 the FDA announced the availability of this guidance for industry.
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The Electronic Common Technical Document (eCTD) v4.0 Q&A v1.3 reaches Step 4 of the ICH Process
On 8 June 2020 the ICH announced that ICH eCTD v4.0 Q&A v1.3 document reached Step 4.
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Guidance on Remote GCP Inspections During the COVID-19 Pandemic
On 10 June 2020 the EMA announced that guidance is available for inspectors on how to initiate and conduct remote inspections to verify compliance with GCP standards during the COVID-19 pandemic.
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EMA Annual Report 2019 Published
On 15 June 2020 the EMA released its annual report highlighting the most significant achievements in 2019.
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Summary of Stakeholder Engagement to Support the Development of ICH E6(R3)
On 18 May 2020 the ICH announced the availability of the summary of the E6(3) stakeholder engagement approach.
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European Medicines Agency Post-authorisation Procedural Advice for Users of the Centralised Procedure
On 18 May 2020 the EMA updated the questions and answers on extensions of marketing authorisations.
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EMA Updates EudraVigilance Registration Manual
On 18 May 2020 the EMA updated the EudraVigilance registration manual.
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Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 25 May 2020 the EMA updated the Q&A document on clinical pharmacology and pharmacokinetics.
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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers
On 26 May 2020 the FDA published this Q&A Guidance for Industry.
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Qualification of digital technology-based methodologies to support approval of medicinal products: Questions and Answers
On 27 May 2020 the EMA published the Q&A document on qualification of digital technologies.
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FDA Provides Free Method to Obtain Informed Consent Electronically for Eligible Clinical Trials During the COVID-19 Public Health Emergency
On 29 May 2020 the FDA announced the availability of the free COVID MyStudies Application (App) for obtaining informed consent remotely.
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MHRA GCP Inspections Metrics Report: 1st April 2017 – 31st March 2018
On 4 May 2020 the UK MHRA issued the GCP inspection metrics report covering the period 1st April 2017 to 31st March 2018.
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Australian TGA Pharmacovigilance Inspection Program Metrics Report: January – December 2019
On 4 May 2020 the Health Department of the Australian Government TGA published the metrics report of pharmacovigilance inspections during 2019.
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Updated Detailed Guidance on ICSRs in the Context of COVID-19: Validity and Coding of ICSRs
On 4 May 2020 the EMA updated the detailed guidance on ICSRs with additional COVID-19 related terms.
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Explanatory Note to GVP Module VII
On 4 May 2020 the EMA updated the guideline on GVP module VII – Periodic Safety Update Report (PSUR).
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EMA SME Office Newsletter – Issue 49
On 7 May 2020 the EMA published the SME Office newsletter for small and medium-sized enterprises (SMEs).
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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 14 May 2020 the FDA updated the guidance for Industry, Investigators, and Institutional Review Boards.
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Annual Report of the Good Clinical Practice Inspectors’ Working Group 2018
On 14 May 2020 the EMA published the annual report adopted by the GCP Inspectors’ Working Group (IWG) on 12 March 2020.
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EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
On 15 May 2020 the EMA announced the availability of the guidance on how EMA fast-tracks development support and approval of medicines and vaccines against COVID-19.
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Fighting the Coronavirus together with the Corona Science App
On 15 April 2020 the Coronavirus Science App developed by Bern University of Applied Sciences and MIDATA was launched to fight the coronavirus together.
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Detailed Guidance on ICSRs in the context of COVID-19
On 21 April 2020 the EMA published the detailed guidance on ICSRs associated with medicinal products used for COVID-19 infection.
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EMA updated EudraVigilance Registration Manual
On 23 April 2020 the EMA published the updated EudraVigilance registration manual.
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eCopy Program for Medical Device Submissions
On 27 April 2020 the FDA issued the updated version of the guidance for industry and FDA staff providing clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.
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Updated Guidance on the Management of Clinical Trials during the Covid-19 (Coronavirus) Pandemic
On 28 April 2020 the EMA updated the Good Clinical Practice guidance on distributor to trial participant IMP shipment, monitoring, remote source data verification and communication with authorities.
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Union Procedure on the Follow-up of Pharmacovigilance Inspections
On 30 April 2020 the EMA published this guideline effective 1 May 2020.
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International Compilation of Human Research Standards 2020 Edition
The Office for Human Research Protections U.S. Department of Health and Human Services compiled the 2020 edition of the international compilation of human research standards.
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New Branch of Widler & Schiemann AG in Germany
Widler & Schiemann AG announced Dr. Andreas Fischer will join as Managing Director for their new German affiliate opening on July 1st this year.
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Welcome Dr. Axel Thiele to join Widler & Schiemann AG as Associate Partner
In April 2020 Dr. Axel Thiele joined Widler & Schiemann AG as Associate Partner. His joining strengthens our expertise in Pharmacovigilance.
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ICH M1 Points to Consider Working Group and MedDRA MSSO Communication on Coronavirus
On 1 April 2020 the ICH announced the notification on MedDRA terms for coronavirus concepts now available
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Global Coronavirus COVID-19 Clinical Trial Tracker
Cytel announced the launch of an open-access global COVID-19 Clinical Trial Tracker.
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Notice to Sponsors on Validation and Qualification of Computerised Systems Used in Clinical Trials
On 7 April 2020 the EMA provided guidance in forms of questions and answers (Q&As) on GCP.
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Overview of Comments Received on ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 7 April 2020 the EMA published an overview of comments received from 40 stakeholders on ICH guideline E8(R1).
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Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics
On 8 April 2020 the FDA published the bioresearch monitoring inspection metrics for the fiscal year 2019.
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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.
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Guidance on regulatory requirements in the context of the COVID-19 pandemic
On 10 April the European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on
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Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
On 13 April 2020 the FDA announced the availability of this final guidance for industry.
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Pharmacovigilance Inspection Metrics Report (April 2018 – March 2019)
On 15 April 2020 the UK MHRA published the annual report of pharmacovigilance inspection metrics from April 2018 till March 2019.
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Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak
On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.
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EMA EudraVigilance Registration Manual
On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.
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Global Regulators Map out Data Requirements for Phase 1 COVID-19 Vaccine Trials
On 24 March 2020 the EMA announced that global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development.
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EMA Management Board – highlights of March 2020 meeting
On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.
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EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
On 20 March 2020 the EMA issued this guidance for industry, investigators and IRBs and on 27 March updated it.
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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
On 20 March 2020 the FDA announced the availability of this final guidance for industry.
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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.
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Guidance on Paediatric Submissions
On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.
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Competitive Generic Therapies
On 13 March 2020 the FDA announced the availability of the final guidance for industry.
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510(k) Third Party Review Program
On 12 March 2020 the FDA issued the guidance for industry, FDA staff and third party review organizations.
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Providing Regulatory Submissions in Alternate Electronic Format
On 10 March 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 11 May 2020.
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GCP Inspections: Expectations and the dos and don’ts for hosting
On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.
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Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
On 10 March 2020 the FDA announced that the agency halts routine inspections overseas through April due to coronavirus.
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China awards Gilead’s remdesivir patents, scolds local pharma over newsjacking
On 10 March 2020 GBI discussed China’s IP landscape and issues surrounding patent standards.
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Safety Testing of Drug Metabolites
On 5 March 2020 the FDA announced the availability of the final guidance for industry.
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ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
On 4 March 2020 the EMA published the Step 5 for ICH guideline Q12.
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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.
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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.
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Orphan medicines in the EU
On 28 February 2020 the EMA published the leaflet on orphan medicines in the EU.
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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.
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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.
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Good manufacturing practice
On 19 February 2020 the EMA updated the GMP guidelines.
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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.
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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.
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New Address for Widler & Schiemann AG in Zug
From 1 March 2020, the company Widler & Schiemamm AG has a new address: Baarerstrasse 75, 6300 Zug
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Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
On 3 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 April 2020.
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European Medicines Agency’s privacy statement for public and targeted consultation
On 14 February 2020 the EMA published its privacy statement for public and targeted consultation.
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Products Management Services (PMS) -Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
On 11 February 2020 the EMA announced the availability of the guideline of implementation of the ISO IDMP standards.
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Substances, Products, Organisations, Referentials (SPOR)
On 11 February 2020 the EMA announced the availability of the SPOR Application Programming Interface (API) version 2 specification.
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ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
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ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
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European Medicines Agency privacy statement for the organisation of meetings and events
On 7 February 2020 the EMA published its privacy statement for the organisation of meetings and events.
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