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On 29 November 2021 the FDA published the draft guidance for industry.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On 4 November 2021 the FDA published the draft guidance for Industry and FDA staff.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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FDA Export Certification
On 20 August 2021 the FDA published the final guidance for industry.
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
On 20 August 2021 the FDA published the draft guidance for industry.
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Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
On 25 August 2021 the FDA published the draft guidance for industry.
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FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 30 August 2021 the FDA published updated guidance for industry, investigators, and Institutional Review Boards.
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Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
On 31 August 2021 the FDA published the final guidance on technical specifications document for industry.
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Clinical Trials Regulation (EU) No 536/2014 Draft
Questions & Answers Version 4
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Six-month Countdown to Go-live for the Clinical Trials Information System (CTIS)
On 2 August 2021 the EMA announced six-month countdown to go-live for the CTIS.
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Belgium - Updated Guidance on Submissions re CTAs, Substantial Amendments, and End-of-trial Declaration
On 5 August 2021 the Belgium FAMHP updated the guidance on the submission of clinical trial applications.
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Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
On 6 August 2021 the FDA published the final guidance on considerations for metastasis-free survival endpoint in clinical trials.
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Development and Submission of Near Infrared Analytical Procedures
On 6 August 2021 the FDA published the final guidance on the development and submission of near infrared analytical procedures.
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Clinical Trials Information System (CTIS) Highlights
On 6 August 2021 the EMA published the issue 4 of the CTIS highlights newsletter from August 2021.
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Regulatory Changes for Software Based Medical Devices
On 9 August 2021 the Australian Therapeutic Goods Administration (TGA) published the guidance on regulatory changes for software based medical devices.
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Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data
On 11 August 2021 the US Department of Justice sentenced clinical researchers in connection with scheme to falsify clinical drug trial data.
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Transfer of Analytical Methods
On 13 August 2021 the article was published on the MHRA inspectorate blog.
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Updated Records of Clinical Trials Information System (CTIS) Webinar about How Sponsor Organisations can Prepare for CTIS
On 13 August 2021 the EMA updated the records of the CTIS webinar event.
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Guidance on Paediatric Submissions: Via eSubmission Gateway and eSubmission Web Client
On 19 July 2021 the EMA announced the availability of the guidance on paediatric eSubmssion.
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Field Alert Report Submission: Questions and Answers
On 22 July 2021 the FDA published the final Q&A guidance on filed alert report submission for industry.
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Guideline on Quality Documentation for Medicinal Products When Used with a Medical Device
On 23 July 2021 the EMA published the guideline on product-specific quality aspects of a medical device.
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Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
On 23 July 2021 the EMA published the reflection paper on GMP and the responsibilities of MAHs.
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Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis
On 28 July 2021 the FDA published the draft guidance. Comments may be submitted by 27 October 2021.
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Clinical Trial Information System (CTIS) - Sponsor Handbook
On 29 July 2021 the EMA announced the availability of the handbook to help clinical trial sponsors preparing for using CTIS.
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ICH Guideline Q13 on Continuous Manufacturing of Drug Substances and Drug Products
On 29 July 2021 the ICH published the Q13 draft guideline.
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Commission Decision (EU) 2021/1240 of 13 July 2021 on the Compliance of the EU Portal and the EU Database for Clinical Trials of Medicinal Products for Human Use with the Requirements Referred to in Article 82(2) of Regulation (EU) No 536/2014 of the Euro
On 31 July 2021 the published the EU commission decision of 13 July 2021 on the compliance of EU portal and EU database for clinical trials.
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Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
On 1 July 2021 the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force.
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Guideline on the Requirements for Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
On 1 July 2021 the EMA published the draft guideline.
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Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
On 1 July 2021 the EMA published the draft guideline, revision 2.
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Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
On 1 July 2021 the FDA published the final guidance for industry.
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Providing Regulatory Submissions in Alternate Electronic Format
On 1 July 2021 the FDA announced the availability of the final guidance for industry.
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Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
On 1 July 2021 the FDA published the draft guidance for industry.
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MHRA Delivery Plan 2021-2023 – Putting Patients First: A New Era for Our Agency
On 5 July 2021 the UK MHRA published its delivery plan for 2021-2023.
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FAQs: Supervise a Clinical Trial Inspection Records: CTIS Training Programme – Module 16
On 6 July 2021 the EMA published the Q&A document regarding module 16 of clinical trial inspection records.
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Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
On 7 July 2021 the FDA published the final guidance for industry and FDA staff.
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Authorisations and Procedures Required for Importing Investigational Medicinal Products to Great Britain from Approved Countries
On 7 July 2021 the UK MHRA updated the guidance on authorisation and procedure requirements for importing IMPs to the UK.
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Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations can Prepare for CTIS
On 14 July 2021 the EMA updated the CTIS webinar information.
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Combined Review to Facilitate Speedier Set Up for Clinical Research Trials
On 15 July 2021 the UK MHRA announced it will publish a combined review of all new clinical trials of IMPs in the UK beginning January 2022.
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Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 17 June 2021 the FDA published the final guidance for industry.
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Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
On 21 June 2021 the FDA published the final guidance for industry.
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Providing Regulatory Submissions in Electronic Format – Standardized Study Data
On 22 June 2021 the FDA published the final guidance for industry.
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