Clinical Trials for Medicines: How to Apply for Authorization in the UK
On 7 January 2022 the MHRA updated the guidance on the new combined review service.
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European Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 for Safety Assessment of Clinical Trials
On 10 January 2022 the EC released guidance on implementing the EU clinical trial regulation for Safety Assessment in Clinical Trials.
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Accelerating Clinical Trials in the EU (ACT EU)
On 13 January 2022 the EMA launched an EU clinical trials transformation initiative.
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EMA EudraVigilance Registration Manual
On 14 January 2022 the EMA updated the EudraVigilance registration manual.
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Clinical Trials Information System (CTIS) Sponsor User Training Program - January 2022
On 14 January 2022 the EMA announced the CTIS sponsor user training program.
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Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents
On 15 December 2021 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 14 February 2022.
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Updated Clinical Trials Information System: Training and Support
On 16 December 2021 the EMA updated the training support for CTIS.
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ICH Guideline Q9 (R1) on Quality Risk Management
On 16 December 2021 the EMA issued the ICH guideline Q9(R1) on quality risk management (step 2b) for public comments. Comments may be submitted until 15 March 2022.
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Inspection of Injectable Products for Visible Particulates
On 17 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 15 February 2022.
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Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol
On 17 December 2021 the EMA issued the final guideline for the notification of serious breaches of EU clinical trial regulation 536/2014 or the clinical trial protocol.
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Progressive Roll-out of In Vitro Diagnostic Medical Devices Regulation
On 17 December 2021 the European Commission released the progressive roll-out of in-vitro diagnostic medical device regulations beginning 26 May 2022.
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Clinical Drug Trial Investigator Charged with Insider Trading
On 20 December 2021 the U.S. Securities and Exchange Commission (SEC) disclosed insider trading charges against investigator.
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Clinical Trials on Medicinal Products in Switzerland
On 20 December 2021 the Swissmedic announced the paperless submission as of 1 January 2022.
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Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
On 22 December 2021 the FDA published the draft guidance for industry, investigators, and other stakeholders. Comments may be submitted until 22 March 2022.
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Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology
On 22 December 2021 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 22 February 2022.
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Innovative Licensing and Access Pathway
On 30 December 2021, the UK MHRA updated the guidance on a new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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Widler & Schiemann AG Appoints Martin E. Zuzulo as New Managing Director - Americas
PRINCETON, NJ, January 4, 2022 – Widler & Schiemann AG is expanding its presence and portfolio of capabilities with the appointment of Martin E. Zuzulo as Managing Director-Americas.
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Clinical Trials Information System (CTIS) – Sponsor Handbook
On 2 December 2021 the EMA updated the CTIS sponsor handbook: a compilation of key guidance, technical information, recommendations and references for getting ready for use of CTIS.
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Establishment and Operation of Clinical Trial Data Monitoring Committees
On 3 December 2021 the FDA published the final guidance for clinical trial sponsors.
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ICMRA and WHO Map out Flexibilities Used by Regulators to Respond to the COVID-19 Pandemic
On 3 December 2021 the EMA announced the regulatory flexibilities to respond to the COVID-19 pandemic.
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IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations
On 7 December 2021 the FDA published the draft guidance for industry. Comments may be submitted by 7 February 2022.
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IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations
On 7 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 7 February 2022.
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Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products
On 8 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 8 March 2022.
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Development of Anti-Infective Drug Products for the Pediatric Population
On 9 December 2021 the FDA published the final guidance for industry.
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CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports
On 9 December 2021 the FDA published the final guidance for industry.
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Substantial Modification of Clinical Investigation under Medical Device Regulation
On 9 December 2021 the European Commission published the medical device coordination group (MDCG) document 2021-28.
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Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
On 9 December 2021 the European Commission published the medical device coordination group (MDCG) Q&A document 2021-27.
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Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry
On 10 December 2021 the FDA published the draft guidance for industry. Comments may be submitted until 10 February 2022.
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Q3C(R8) Impurities: Guidance for Residual Solvents
On 10 December 2021 the FDA published the final guidance for industry.
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Highlights from the 16th EMA Industry Platform Meeting on the Operation of EU Pharmacovigilance Legislation
On 10 December 2021 the EMA published highlights from the 16th Pharmacovigilance Industry Platform meeting.
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Global Reflections on International Inspection Transformation: ICMRA Remote Inspections
On 10 December 2021 the MHRA Inspectorate published an article by Paula Walker.
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EU Country Health Profiles
On 13 December 2021 the European Commission released the 2021 edition of country health profiles.
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Clinical Trials Information System (CTIS) Highlights
On 13 December 2021 the EMA published CTIS highlights.
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Adjustments Required for Entering Drug Manufacturers into the EudraGMDP Database
On 14 December 2021 the Swissmedic announced the adaptation for the integration of the EudraGMDP with the organization management service (OMS).
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MHRA Updated Guidance on Managing Clinical Trials during Coronavirus (COVID-19)
On 16 November 2021 the UK MHRA updated the Urgent Safety Measures section of its guidance on managing clinical trials during COVID-19.
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IRIS Guide for Applicants
On 24 November 2021 the EMA updated the IRIS guide for applicants, version 2.4.
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Press Release: ICH Assembly Virtual Meeting, November 2021
On 25 November 2021 the ICH released the ICH assembly virtual meeting on 17 and 18 November.
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EU Commission Implementing Regulation (EU) 2021/2078 re the Application of Regulation (EU) 2017/745 and the European Database on Medical Devices (Eudamed)
On 26 November 2021 the EC laid down rules for the application of Regulation (EU) 2017/745 and the European database on medical devices.
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Annual Report of the Pharmacovigilance Inspectors Working Group (PhV IWG) for 2019 and 2020
On 26 November 2021 the EMA published the annual report of PhV IWG for 2019 and 2020. It was adopted by the PhV IWG on 12 November 2021.
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EMA’s Guide on Advanced Therapy Medicinal Products - Clinical Development
On 29 November 2021 the EMA published the flowchart guide on advanced therapy medicinal products during the clinical development.
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Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
On 29 November 2021 the FDA published the draft guidance for industry. Comments may be submitted by 28 February 2022.
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Updated Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) including Pharmacovigilance System Master Files (PSMF)
On 30 November 2021 the UK MHRA updated the guidance on requesting a UK PSMF number.
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Position Paper by Swissmedic and Swissethics on Decentralized Clinical Trials (DCTs) with Medicinal Products
On 1 November 2021 the Swissmedic issued the updated guidance on DCTs.
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Content of Premarket Submissions for Device Software Functions
On 4 November 2021 the FDA published the draft guidance for Industry and FDA staff. Comments may be submitted by 2 February 2022.
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Good Practice on the Assessment of GMO-Related Aspects in the Context of Clinical Trials with Human Cells Genetically Modified
On 6 November 2021 the European Commission updated the guidance, version 5.
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Common Application Form for Clinical Research with Human Cells Genetically Modified
On 6 November 2021 the European Commission published the updated version of the common application form for clinical research with human cells genetically modified.
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Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
On 15 November 2021 the FDA published the updated guidance for Developers and FDA staff.
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Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 15 November 2021 the FDA published the updated guidance for Commercial Manufactures, Clinical Laboratories and FDA staff.
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Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 15 November 2021 the UK MHRA updated the GLP guidance.
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Updated FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014
On 15 November 2021 the EMA published the updated guidance on the FAQs of CTIS training program module 1.
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Updated Instructor’s Guide: Introduction to the Clinical Trials Regulation (EU) No 536/2014
On 15 November 2021 the EMA published the updated guidance on the instructor’s guide of CTIS training program module 1.
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Clinical Trials Information System (CTIS) Highlights
On 18 October 2021 the EMA published CTIS Highlights, Issue 5.
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Guidance on the Electronic Submission of Information on Investigational Medicinal Products for Human Use in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
On 20 October 2021 the EMA published the Extended EudraVigilance Medicinal Product Report (XEVPRM) user guidance for sponsors of clinical trials.
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Data Standards for Drug and Biological Product Submissions Containing Real-World Data
On 21 October 2021 the FDA published the draft guidance for industry. Comments may be submitted until 21 January 2022.
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CMDh Best Practice Guide on Multilingual Packaging
On 22 October 2021 the Coordination Group for Mutual Recognition and Decentralized Procedures—Human (CMDh) updated the best practice guide on multilingual packaging.
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Updated Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues
On 26 October 2021 the UK MHRA updated the “Apply to change your trial’s protocol or documentation” section of clinical trials for medicines guidance.
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Study Coordinator Pleads Guilty in Scheme to Falsify Clinical Drug Trial Data
On 26 October 2021 the US Department of Justice announced investigation into case of falsifying clinical drug trial data.
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Good Machine Learning Practice for Medical Device Development: Guiding Principles
On 27 October 2021 the FDA, Health Canada, and the UK MHRA jointly issued GMLP guiding principles.
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Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
On 29 October 2021 the FDA published the final guidance for industry.
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Principles for Sponsor Organization Modelling for CTIS
On 29 October 2021 the EMA published the version 2 of the guidebook.
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Good Lay Summary Practice
On 4 October 2021 the European Commission added guidance to Chapter V of EudraLex Volume 10.
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Content and Format of Substantial Equivalence Reports; FDA Actions on Substantial Equivalence Reports
On 5 October 2021 the FDA published the final rule on the content and format of substantial equivalence reports.
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Medical Device De Novo Classification Process
On 5 October 2021 the FDA published the final rule on the medical device De Novo classification process.
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European Union Clinical Trials Information System CTIS: Go-live Planning
On 8 October 2021 the EMA published the summary of key areas in preparation for the CTIS implementation.
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More Than 100 Applications Lost Equivalence Rating Thanks to Allegedly Falsified Data at Two CROs
On 11 October 2021 Informa.com published analysis on the impact of data integrity issues.
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Q13 Continuous Manufacturing of Drug Substances and Drug Products
On 12 October 2021 the FDA published the draft guidance for industry.
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Clinical Trials Information System (CTIS): Virtual Information Day
On 13 October 2021 the EMA announced the CTIS virtual information day taking place on 26 October 2021.
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MA Adopts ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 14 October 2021 the EMA adopted the ICH guideline E8 (R1), step 5, effective 14 April 2022.
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European Commission Proposes a Progressive Roll-out of the New In Vitro Diagnostic Medical Devices Regulation
On 14 October 2021 the European Commission published a proposal on a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation.
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UK MHRA Updated Guidance on Pharmacovigilance Procedures
On 14 October 2021 the UK MHRA updated the guidance on pharmacovigilance procedures.
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Clinical Trials Regulation (EU) No 536/2014 Draft Questions & Answers
On 14 October 2021 the European Commission published draft Q&A guidance, version 4.1.
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Clinical Trials Information System (CTIS): Virtual Information Day
On 16 September 2021 the EMA announced the virtual CTIS information day on 26 October 2021.
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Q2(R1) Validation of Analytical Procedures: Text and Methodology
On 16 September 2021 the FDA published the final guidance for industry.
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Updated IRIS Guide for Applicants
On 16 September 2021 the EMA updated the IRIS guide on how to create and submit scientific application, for industry and individual applicants.
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Questions and Answers on Biosimilar Development and the BPCI Act
On 17 September 2021 the FDA published the final Q&As guidance for industry.
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Questions and Answers on Quality Related Controlled Correspondence
On 20 September 2021 the FDA published the draft guidance for industry.
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Procedural Advice for Orphan Medicinal Product Designation
On 27 September 2021 the EMA published this guidance for sponsors.
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Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products
On 28 September 2021 the FDA published the draft guidance for industry.
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Electronic Submission Template for Medical Device 510(k) Submissions
On 29 September 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 28 November 2021.
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Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
On 29 September 2021 the FDA published the draft guidance for industry.
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Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
On 29 September 2021 the FDA published the final guidance for industry.
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Benefit-Risk Assessment for New Drug and Biological Products
On 29 September 2021 the FDA published the draft guidance. Comments should be submitted by 29 November 2021.
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Clinical Trials for Medicines: Apply for Authorization in the UK
On 30 September 2021 the UK MHRA updated the guidance on how to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to the application.
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Targeted Stakeholder Consultation on the Amendments to Commission Implementing Regulation (EU) 520/2012 on Pharmacovigilance Activities
On 1 September 2021 the European Commission announced the targeted stakeholder consultation from 31 August to 15 October 2021.
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UK MHRA and US FDA Tackle Challenging Data Integrity
On 1 September 2021 the UK MHRA Inspectorate published the white paper on 2020 MHRA and FDA joint Good Clinical Practice (GCP) symposium.
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UK MHRA Updated Managing Clinical Trials During Coronavirus (COVID-19)
On 8 September 2021 the UK MHRA updated guidance on managing clinical trials during COVID-19.
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Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers
On 8 September 2021 the FDA published the final Q&A guidance for industry.
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S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 9 September 2021 the FDA published the ICH S12 draft guidance for industry.
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Technical Workshop on Real-world Metadata for Regulatory Purposes
On 9 September 2021 the EMA published the summary report of the technical workshop that took place on 12 April 2021.
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Webinar for Small and Medium-sized Enterprises (SMEs) and Academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
On 10 September 2021 the EMA announced a webinar for SMEs and academia on 29 November 2021.
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Updated Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products
On 10 September 2021 the Danish Medicines Agency announced the availability of the updated guidance version 2.0.
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Detailed Guidance on the Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorization Holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004
On 14 September 2021 the EMA updated the extended EudraVigilance Medicinal Product Report Message (XEVPRM) user guidance.
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Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products - General Principles
On 15 September 2021 the EMA published the EMA-FDA PSA program.
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Guidance for Notified Bodies, Distributors and Importers on Certification Activities in Accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
In August 2021 the Medical Device Coordination Group (MDCG) published guidance of MDCG 2021-23.
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DAIDS Good Clinical Laboratory Practice Guidelines
On 16 August 2021 the Division of AIDS (DAIDS) in the U.S. National Institute of Allergy and Infectious Diseases (NIAID) published the GCLP guidelines.
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General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
On 18 August 2021 the EMA published updated general principles on EMA-FDA parallel scientific advice.
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Australian Therapeutic Goods Administration (TGA) Reduces Timeframe for Publishing Adverse Event Reports
On 19 August 2021 the TGA announced a reduced timeframe for publishing adverse event reports.
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Notifying FDA of Fatalities Related to Blood Collection or Transfusion
On 20 August 2021 the FDA announced updated guidance for industry.
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