Workshop on the General Data Protection Regulation (GDPR) and Secondary Use of Data for Medicines and Public Health Purposes
On 5 March 2021 the EMA published the presentation materials from the workshop held on 29 September 2020.
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Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland/Northern Ireland
On 5 March 2021 the EMA issued additional practical Q&A guidance on the applicable rules in Northern Ireland after the transition period with respect to EMA activities and medicinal products for human and veterinary use within the framework of the centralized procedure.
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Register Medical Devices to Place on the Market
On 12 March 2021 the MHRA updated the guidance on how to register medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
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EMA Updated Clinical Trials Information System Development
On 12 March 2021 the EMA announced updated information on the clinical trials information system (CTIS).
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Labelling Flexibilities for COVID-19 Therapeutics
On 12 March 2021 the EMA announced the availability of guidance on labelling flexibilities for COVID-19 treatments.
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EMA Updated Q&A: Good Clinical Practice
On 16 February 2021 the EMA updated GCP Q&A by adding a new Q&A (#15) to the GCP Matters section.
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Audit Checklist – Interpretation Guide
On 16 February 2021 the EMA published the first interpretation guide to support the common audit checklist, in cooperation with the members of the joint audit programme.
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MHRA Updated Guidance on Managing Clinical Trials during COVID-19
On 17 February 2021 the MHRA updated the guidance by adding a section on the management of COVID-19 vaccine deployment for ongoing non-COVID-19 clinical trials.
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Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests
On 22 February 2021 the FDA issued initial guidance for test developers and FDA staff.
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Emergency Use Authorization for Vaccines to Prevent COVID-19
On 22 February 2021 the FDA issued additional guidance for industry.
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Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management services: Chapter 8 – Practical examples.
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Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe: Chapter 3
On 22 February 2021 the EMA published the new regulatory and procedural guideline on product management service: Chapter 3 – Process for the electronic submission of medicinal products information.
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Clinical Trials Regulation (EU) No 536/2014: Questions & Answers
On 24 February 2021 the European Commission released the draft Q&A on EU clinical trials regulation No 536/2014, version 3.
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MHRA Pharmacovigilance Inspection Metrics: April 2019 to March 2020
On 26 February 2021 the MHRA GPvP inspectorate published the latest inspection metrics for the period from April 2019 to March 2020.
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Chinese NMPA Released the National Medical Products Newsletter
In January 2021 the Chinese NMPA published 2021 Volume I of the National Medical Products Newsletter.
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Draft Toolbox Guidance on Scientific Elements and Regulatory Tools to Support Quality Data Packages for PRIME Marketing Authorization Applications
On 2 February 2021 the EMA published the draft toolbox guidance. Comments should be submitted by 31 July 2021.
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EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum II
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI Addendum II – Methods for Effectiveness Evaluation. Comments should be submitted by 28 April 2021.
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EMA Guideline on Good Pharmacovigilance Practices (GVP) Module XVI
On 3 February 2021 the EMA published the draft guideline on GVP Module XVI – Risk Minimization Measures: Selection of Tools and Effectiveness Indicators (Rev 3). Comments should be submitted by 28 April 2021.
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Guidance on the Management of Clinical Trials During the Covid-19 (Coronavirus) Pandemic
On 4 February 2021 the EMA published guidance version 4 with the key changes of remote source data verification.
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Reference Safety Information (RSI) for Clinical Trials – Part III
On 5 February 2021 the MHRA GCP inspectorate published the RSI blog posts Part III.
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EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 8 February 2021 the EMA published the post-authorization guidance.
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Investigational COVID-19 Convalescent Plasma
On 11 February 2021 the FDA published revised guidance for industry.
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MHRA Guidance on Pharmacovigilance Requirements for UK Authorized Products from 1 January 2021
On 12 February 2021 the guidance was published on the MHRA inspectorate blog.
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GCP Inspections Metrics Report
On 12 February 2021 the MHRA GCP Inspectorate issued the GCP inspections metrics report covering 1 April 2018 to 31 March 2019.
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FDA Released Artificial Intelligence/Machine Learning Action Plan
On 12 January 2021 the FDA released the agency’s first artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) action plan.
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Guidelines 01/2021on Examples Regarding Data Breach Notification
On 18 January 2021 the European Data Protection Board announced the notification for public consultation. Comments should be sent by 2 March 2021.
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Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency
On 19 January 2021 the FDA published the final guidance for industry.
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Commission Notice – Application of the Union’s Pharmaceutical Acquis in Markets Historically Dependent on Medicines Supply from or through Great Britain after the End of the Transition Period
On 25 January 2021 the EMA published the European Commission notice to stakeholders.
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Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe
On 25 January 2021 the European Network of Paediatric Research at the EMA’s (Enpr-EMA’s) Working Group on Ethics developed the guidance.
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FDA Updated Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 27 January 2021 the FDA updated the final guidance for industry, investigators and institutional review boards.
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Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 28 January 2021 the FDA published the final guidance for industry and FDA staff.
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Overview of Comments Received on 'Draft Questions and Answers on Data Monitoring Committees Issues' (EMA/492010/2018)
On 29 January 2021 the EMA published the overview of comments on draft Q&A on Data Monitoring Committees Issues.
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IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations
On 4 January 2021 the FDA announced the availability of the draft guidance for sponsor-investigators. Comments may be submitted until 4 March 2021.
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Human Gene Therapy for Neurodegenerative Diseases
On 5 January 2021 the FDA announced the availability of the draft guidance for industry.
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Safer Technologies Program for Medical Devices
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program
On 6 January 2021 the FDA announced the availability of the final guidance for industry and FDA staff.
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Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data
On 8 January 2021 the FDA released press on a sentence of medical doctor falsifying clinical trial data.
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COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity
On 13 January 2021 the FDA published the guidance.
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EMA Procedural Advice for Users of the Centralized Procedure
On 13 January 2021 the EMA updated 3 guidance on pre-/post-authorization procedural advice for users of the centralized procedure or for generic/hybrid applications.
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EMA Updated Guidance on Obtaining and Maintaining a Scientific Opinion on a Medicine for Use Outside the EU
On 14 January 2021 the EMA updated the guidance on promoting parallel application for EU-M4all opinion and centralized marketing authorization procedure.
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EMA Updated Questions & Answers on Signal Management
On 15 January 2021 the EMA published revision 4 of the Q&A on signal management.
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Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
On 15 January 2021 the FDA published the final guidance for industry.
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EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.
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EMA Updated Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.
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Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
On 16 December 2020 the FDA announced the availability of the final guidance for industry.
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ontrolled Correspondence Related to Generic Drug Development Guidance for Industry
On 16 December 2020 the FDA published the final guidance for industry.
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Dry Eye: Developing Drugs for Treatment
On 16 December 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 17 March 2021.
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EMA Updated IRIS Guide for Applicants
On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.
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Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
On 17 December 2020 the FDA announced the availability of the final guidance for industry.
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EMA Updated Clinical Trials Information System Development
On 18 December 2020 the EMA published the updated clinical trials information system (CTIS) development.
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Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 21 December 2020 the EMA published the guidance for sponsors.
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Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry
On 21 December 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 (Revised)
On 22 December 2020 the FDA published the updated Q&A guidance for industry and FDA staff.
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Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
On 23 December 2020 the FDA published the final guidance for industry.
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MHRA Guidance on Submitting Clinical Trial Safety Reports
On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).
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Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority
On 31 December 2020 the MHRA published a guidance note on GVP.
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MHRA Guidance on Substantial Amendments to a Clinical Trial
On 31 December 2020 the MHRA published guidance on substantial amendments to a clinical trial.
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Requesting FDA Feedback on Combination Products
On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.
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Update to FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
On 4 December 2020 the FDA Updated the Final Guidance for Industry, Investigators, and Institutional Review Boards.
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Reflection Paper on Patient-Focused Drug Development for Public Consultation
On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.
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MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021
On 7 December 2020 the MHRA Updated the Medical Devices Guidance.
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Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.
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European Medicines Agencies Network Strategy to 2025
On 8 December 2020 the EMA Published the Joint Strategy Setting Direction for EMA and EU Medicines Regulatory Agencies to 2025.
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The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process
On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.
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Clinical Trials Information System (CTIS) Highlights – December 2020
On 9 December 2020 the EMA Published Issue 2 of CTIS Highlights.
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Best Practices in Developing Proprietary Names for Human Prescription Drug Products
On 9 December 2020 the FDA Announced the Availability of the Final Guidance for Industry.
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Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
On 11 December 2020 the FDA Issued the Final Guidance for Industry and FDA Staff.
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Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland
On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.
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Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider
On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.
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Clinical Drug Interaction Studies with Combined Oral Contraceptives
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 22 February 2021.
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Cross Labeling Oncology Drugs in Combination Regimens
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
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Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
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Qualification Process for Drug Development Tools
On 24 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
On 24 November 2020 the FDA announced the availability of the final guidance for industry.
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On-site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials
On 26 November 2020 the UK MHRA published the new guidance for Sponsors, CROs and investigator sites.
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Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry
On 30 November 2020 the FDA published the draft guidance for industry. Submit comments by 26 February 2021.
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MHRA Updated Guidance on Pharmacovigilance Procedures
On 30 November 2020 the MHRA updated the guidance on pharmacovigilance procedures.
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EMA Updated Q&A: Good Clinical Practice (GCP)
On 3 November 2020 the EMA added a new Q&A (#14) to the GCP matters section.
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Joint Guidance of Swissmedic and Swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland during the COVID-19 Pandemic
On 4 November 2020 Swissmedic and swissethics issued version 2.3 of their joint guidance.
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Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
On 6 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
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Drug Trial Snapshots Summary Report – from 2015 to 2019
On 9 November 2020 the FDA announced the availability of a five-year summary and analysis of clinical trials participation and demographics.
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Regulatory Considerations for Microneedling Products
On 9 November 2020 the FDA issued the final guidance for industry and FDA staff.
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Detailed Guide Regarding the EudraVigilance Data Management Activities by the EMA
On 9 November 2020 the EMA announced the availability of the updated guide.
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Guidance on Minimizing Disruptions to the Conduct and Integrity of Clinical Trials of Medicines During COVID-19
On 11 November 2020 the UK MHRA issued the guidance.
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Information on the Member States Requirement for the Nomination of a Pharmacovigilance (PhV) Contact Person at National Level
On 11 November 2020 the EMA PhV Inspectors Working Group (IWG) updated the information on PhV contact person.
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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
On 13 November 2020 the FDA issued the final guidance for industry.
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Certificates of Confidentiality
On 13 November 2020 the FDA issued the final guidance for sponsors, sponsor-investigators, researchers, industry, and FDA staff.
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Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance
On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.
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Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products
On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.
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EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 19 October 2020 the EMA issued guidance revision 10 addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.
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Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population
On 22 October 2020 the EMA issued this reflection paper for medicine developers.
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Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021
On 23 October 2020 the MHRA updated guidance on the QPPV and PSMF for UK authorized products.
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Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
On 20 October 2020 the FDA announced the availability of the draft guidance for industry.
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Updated Guidance on Pharmacovigilance (PV) Procedures
On 27 October 2020 the MHRA published the updated guidance on PV procedures.
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Referencing Approved Drug Products in ANDA Submissions
On 27 October 2020 the FDA announced the availability of the final guidance for industry.
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Providing Regulatory Submissions in Electronic Format — Standardized Study Data
On 29 October 2020 the FDA announced the availability of the final guidance for industry.
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Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
On 1 October 2020 the FDA announced the availability of the final guidance for industry.
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EMA Updated the Status of Clinical Trials Information System (CTIS)
On 5 October 2020 the EMA announced that the audit of the clinical trial information system (CTIS) will commence in November 2020.
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Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.
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MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.
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