ANDA Submissions – Prior Approval Supplements Under GDUFA
14 October 2022 — FDA published final guidance on ADNA submissions for industry.
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IRIS Guide for Parallel Distribution Applicants
3 October 2022 — EMA published the updated IRIS guide for parallel distribution applicants.
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Presentation – Clinical Trials Information System (CTIS) Bitesize Talk (Notifications - Part 1)
3 October 2022 — EMA published part 1 of the recent CTIS bitesize talk presentation.
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FAQs: How to Evaluate a CTA – CTIS Training Program Module 06
5 October 2022 — EMA published version 1.4 FAQs on how to evaluate a CTA.
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Reflection Paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials, with Particular Emphasis on the Handling of Expiry Dates
5 October 2022 — EMA published the updated reflection paper on the use of IRT.
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ICH Guideline S1B(R1) on Testing for Carcinogenicity of Pharmaceuticals
10 October 2022 — EMA published the ICH guideline S1B1(R1) – Step 5.
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Data Quality Framework for EU Medicines Regulation
10 October 2022 — EMA published the draft data quality framework for the public consultation until 18 November 2022.
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Updated Q&A: Good Clinical Practice (GCP)
10 October 2022 — EMA published updated Q&A guidance on GCP.
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IRIS Guide for Applicants
10 October 2022 — EMA published version 2.13 of the IRIS guide for applicants.
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EMA Account Management Training Session Presentation
11 October 2022 — EMA published the presentation shown at the account management training session.
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EMA IRIS Industry Training for GVP Inspections: Questions & Answers
11 October 2022 — EMA published the Q&A guidance on IRIS industry training for GVP inspections.
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Digital Application Dataset Integration (DADI) eAF Training Webinars (26 July 2022 & 2 September 2022): Questions and Answers
12 October 2022 — EMA published the Q&A guidance on the recent DADI eAF webinars
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European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
14 October 2022 — EMA published rev. 14 guidance for applicants seeking scientific advice and protocol assistance.
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Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 September 2022 the EMA published the Q&A guidance on labeling flexibilities for COVID-19 vaccines.
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Concept Paper on the Establishment of a Guideline on the Development and Manufacture of Synthetic Oligonucleotides
On 16 September 2022 the EMA published the draft guidance for consultation from 20 September 2022 to 20 December 2022.
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The Northern Ireland MHRA Authorized Route (NIMAR)
On 20 September 2022 the MHRA published the updated NIMAR guidance.
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Notify the MHRA about a Clinical Investigation for a Medical Device
On 21 September 2022 the MHRA published the updated guidance on notification of clinical investigation for medical devices.
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How to Obtain a Covered Product Authorization
On 21 September 2022 the FDA published the draft guidance for industry. Submit comments by 21 November 2022.
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Electronic Submission Template for Medical Device 510(k) Submissions
On 22 September 2022 the FDA published the final guidance for industry and FDA staff.
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IRIS Guide for Applicants
On 23 September 2022 the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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FAQs: How to Create, Submit and Withdraw a Clinical Trial Application — CTIS Training Program - Module 10
On 23 September 2022 the EMA published version 1.3 of the updated FAQs guidance on how to create, submit and withdraw a clinical trial application.
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Ethical Considerations for Clinical Investigations of Medical Products Involving Children
On 26 September 2022 the FDA published the draft guidance for industry, sponsors and IRBs.
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Update - EudraLex - Volume 10 - Clinical trials guidelines - Questions and Answers Document - Regulation (EU) 536/2014 – Version 6.2 (September 2022)
On 26 September 2022 the European Commission published the updated Q&A document on clinical trials regulation EU 536/2014, version 6.2.
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Good Clinical Practice for Clinical Trials
On 27 September 2022 the MHRA published the updated guidance on GCP for clinical trials.
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Providing Over-the-Counter Monograph Submissions in Electronic Format
On 27 September 2022 the FDA published the draft guidance. Submit comments by 28 November 2022.
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Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
On 27 September 2022 the FDA published updated guidance for developers and FDA staff.
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Checking Process of Mock-Ups and Specimens of Outer/Immediate Labeling and Package Leaflets of Human Medicinal Products in the Centralized Procedure
On 28 September 2022 the EMA published the guidance on checking process of mock-ups and specimens.
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Policy for Device Software Functions and Mobile Medical Applications
On 28 September 2022 the FDA published the final guidance on the regulatory oversight to certain software for industry and FDA staff.
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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
On 28 September 2022 the FDA published the final guidance on regulatory oversight to certain medical devices for industry and FDA staff.
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Display Devices for Diagnostic Radiology
On 28 September 2022 the FDA published the final guidance on premarket notification submissions for display devices for industry and FDA staff.
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Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
On 28 September 2022 the FDA published the final guidance on premarket notification submissions for computer-assisted detection devices for industry and FDA staff.
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Clinical Decision Support Software
On 28 September 2022 the FDA published the final guidance on the scope of oversight of clinical decision support software.
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Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
On 28 September 2022 the FDA published final guidance for industry and FDA staff.
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Procedural Advice for Post-Orphan Medicinal Product Designation Activities
On 30 September 2022 the EMA published revision 13 on guidance for post-orphan designated products for sponsors.
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Manual on Borderline and Classification for Medical Devices under Regulation (EU)
In September 2022 the European Commission published version 1 of the manual on borderline and classification for medical devices.
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Accelerating Clinical Trials in the EU (ACT EU) Multi-Annual Workplan 2022-2026
On 2 September the EMA published the updated ACT EU multi-annual workplan.
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Swissmedic Online Information Event: New Regulations on In Vitro Diagnostic Medical Devices
On 5 September Swissmedic announced an online information event for new regulations on in vitro diagnostic medical devices.
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Updated IRIS Guide for Applicants
On 5 September the EMA published version 2.12 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products
On 7 September 2022 the FDA published draft guidance on clinical pharmacology considerations for pediatric studies.
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EMA IRIS Industry Training for GVP Inspections
On 8 September the EMA published their online training sessions of IRIS for GCP inspections.
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Medical Devices: Software Applications (Apps)
On 8 September 2022 the MHRA published updated guidance on software apps as medical devices.
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Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products
On 8 September 2022 the FDA published the final guidance on real-world data and real-world evidence.
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Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
On 8 September 2022 the FDA published the draft guidance on quantitative labeling. Submit comments by 8 November 2022.
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Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products
On 8 September 2022 the FDA published draft guidance on content and format of labeling for human nonprescription drug products. Submit comments by 8 November 2022.
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Certificates of Free Sale to Danish Manufacturers of Medical Devices
On 12 September 2022 the Danish Medicines Agency updated the medical devices guidance on certificates of free sale.
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Policy for Monkeypox Tests to Address the Public Health Emergency
On 13 September 2022 the FDA published final guidance on monkeypox tests for laboratories, commercial manufacturers and FDA staff.
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Computer Software Assurance for Production and Quality System Software
On 13 September 2022 the FDA published draft guidance on computer software assurance for industry and FDA staff. Submit comments by 14 November 2022.
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Q3D(R2) – Guideline for Elemental Impurities
On 14 September 2022 the FDA published draft guidance on elemental impurities.
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Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
On 17 August 2022 FDA issued final guidance for industry and FDA staff.
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A Regulatory Pharmaceutical Quality Knowledge Management System (PQKMS) to Enhance the Availability of Quality Medicines
On 17 August 2022 ICMRA (International Coalition of Medicines Regulatory Authorities) published a joint reflection paper in support of the regulatory PQ KMS.
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Charging for Investigational Drugs Under an IND – Questions and Answers
On 23 August 2022 FDA published revised draft Q&A guidance. Submit comments by 24 October 2022.
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Information Event “Regulatory & Beyond”
On 22 August 2022 Swissmedic announced a hybrid information event “Regulatory & Beyond” to be held on 20 September 2022 in Bern.
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Innovation, Quality & Transparency – a Compliance Team 1 Perspective
On 23 August 2022 UK MHRA Inspectorate published a blog on Compliance Matters.
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EMA EudraVigilance Registration Manual
On 23 August 2022 EMA published the updated EudraVigilance registration manual.
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Sponsors’ Guide: Transitional Trials from EudraCT to CTIS (sponsor users)
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
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FAQs: Transitional Trials from EudraCT to CTIS
On 24 August 2022 EMA published the CTIS training program, module 23, version 1.2.
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Revision – Manufacture of Sterile Medicinal Products
On 25 August 2022 the European Commission published the revised guideline for GMP in the EudraLex Volume 4, annex 1.
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E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential – Questions and Answers
On 26 August 2022 the FDA published final Q&A guidance on ICH E14 and S7B.
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Q2(R2) Validation of Analytical Procedures
On 26 August 2022 the FDA published draft guidance on ICH Q2(R2).
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Q14 Analytical Procedure Development
On 26 August 2022 the FDA published draft guidance on ICH Q14.
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M12 Drug Interaction Studies
On 26 August 2022 the FDA published draft guidance on ICH M12.
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E11A Pediatric Extrapolation
On 26 August 2022 the FDA published draft guidance on ICH E11A.
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Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
On 31 August 2022 the EMA published guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, version 3.0.
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Changes to Guidance Document Authorization Procedures for COVID-19 Medicinal Products During a Pandemic HMV4
1 August 2022 — Swissmedic published the revised guidance document effective 1 August 2022.
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Digital Application Dataset Integration (DADI) Q&A Webinar - Variations Form for Human Medicinal Products
2 August 2022 — EMA published the DADI Q&A webinar summary document.
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News Bulletin for Small and Medium-Sized Enterprises (SME)
2 August 2022 — EMA published Issue 56 of the SME Office Newsletter.
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Application for Priority Applicant Determination - Medical Devices
2 August 2022 — Australian Therapeutic Goods Administration (TGA) announced the availability of the application form for priority applicant determination of medical devices.
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Version 2.8 of Technical Documentation - UDI/Devices Registration
2 August 2022 — European Commission published the technical documentation version 2.8 for unique device identifier (UDI)/Devices registration.
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Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues
2 August 2022 — MHRA updated the guidance on clinical trials for medicines.
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Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
2 August 2022 — FDA published draft guidance for industry. Submit comments by 3 October 2022.
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EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
3 August 2022 — EMA published guidance on rapid formal review procedures related to COVID-19.
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Decommission of eSUSAR
3 August 2022 — MHRA inspectorate announced decommission of eSUSAR.
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Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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EVVet3 Production - Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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EVVet3 Production – Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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Clinical Trials for Medicines: Apply for Authorization in the UK
On 18 July 2022 the MHRA updated the guidance on clinical trials for medicines.
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Evaluation of Therapeutic Equivalence
On 21July 2022 the FDA published the draft guidance on evaluation of therapeutic equivalence of generic drugs. Submit comments by 19 September 2022.
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Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 21 July 2022 the MHRA updated the guidance on GLP
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ICH Guideline M12 on Drug Interaction Studies
On 21 July 2022 the EMA published the draft ICH guideline M12, step 2b.
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Global Regulators Call for International Collaboration to Integrate Real-World Evidence into Regulatory Decision-Making
On 22 July 2022 the EMA announced the availably of a joint ICMRA statement on international collaboration to enable RWE for regulatory decision-making.
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Real-Time Oncology Review (RTOR)
On 22 July 2022 the FDA published the draft guidance on real-time oncology review for industry. Submit comments by 20 September 2022.
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Conducting Remote Regulatory Assessments Questions and Answers
On 22 July 2022 the FDA published the draft Q&A guidance on conducting remote regulatory assessments for industry.
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Failure to Respond to an Abbreviated New Drug Applications (ANDA) Complete Response Letter (CRLs) within the Regulatory Timeframe
On 22 July 2022 the FDA published the final guidance on responding to complete response letters (CRLs) from FDA for industry.
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Orange Book Questions and Answers Guidance for Industry
On 22 July 2022 the FDA published the final orange book Q&A guidance for industry.
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Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices
On 22 July 2022 the FDA published the final UDI guidance for industry and FDA staff.
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Clinical Trials Highlights - July 2022
On 25 July 2022 the EMA published the Clinical Trials Highlights, issue 10.
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ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis
On 27 July 2022 the EMA published the ICH guideline M10, step 5.
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ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis – Frequently Asked Questions (FAQ)
On 27 July 2022 the EMA published the FAQ on ICH guideline M10, step 5.
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General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
On 27 July 2022 the FDA published the final guidance on general clinical pharmacology considerations for neonatal studies
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Laser-Assisted in Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
On 28 July 2022 the FDA published the draft guidance on patient labeling recommendations for LASIK lasers for industry and FDA staff. Submit comments by 26 October 2022.
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Qualification Opinion of the Use of Enroll-HD (A Huntington’s Disease Patient Registry) as a Data Source and Infrastructure Support for Post-Authorization Monitoring of Medical Products
On 28 July 2022 the EMA published the qualification opinion on the use of Enroll-HD as a data source and infrastructure support for post-authorization monitoring of medical products.
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Register Medical Devices to Place on the Market
On 28 July 2022 the MHRA updated the guidance on registration of medical devices.
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PMDA Guidance on Risk Management Plan (RMP)
On 29 July 2022 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) posted RMP page renewal, Q&A, templates, instructions and publication.
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