Clinical Trials Information System (CTIS) - Sponsor Handbook
30 November 2022 – EMA published version 3.0 of the CTIS sponsor handbook.
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European Medicines Agency Pre- and Post-Authorization Procedural Advice for Users of the Centralized Procedure
4 November 2022 – EMA updated guidance on pre- and post-authorization procedural advice for users of the centralized procedure.
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Anonymization of Protected Personal Data and Assessment of Commercially Confidential Information during the Preparation of RMPs
4 November 2022 – EMA updated RMP guidance (main body and annexes 4 & 6) for protected personal data and confidential information.
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Procedural Advice for Orphan Medicinal Product Designation
7 November 2022 – EMA updated guidance on the orphan medicinal product designation for sponsors.
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CTIS Training Program Module 07 Updates
8 November 2022 – EMA updated training module 07 of the CTIS step-by-step guide.
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ICH M11 Draft Guideline Reaches Step 2
On 21 October 2022 the ICH announced the ICH M11 draft guidelines reached step 2 of the ICH process.
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ICH E19 Introductory Training Presentation Available
On 25 October 2022 the ICH announced the E19 introductory training presentation available.
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Software and AI as a Medical Device Change Program
On 17 October 2022 the UK MHRA introduced a roadmap for software and AI as a medical device change program.
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Guidance on Pharmacovigilance Procedures
On 25 October 2022 the UK MHRA published the updated guidance on PV procedures.
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Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials
On 17 October 2022 the FDA published the draft guidance on immune-mediated adverse reactions in cancer immunotherapeutic clinical trials for industry.
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Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
On 17 October 2022 the FDA published the final guidance on acute myeloid leukemia treatment for industry.
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Tissue Agnostic Drug Development in Oncology
On 17 October 2022 the FDA published the draft guidance on tissue agnostic drug development in oncology for industry.
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Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
On 21 October 2022 the FDA published the draft guidance for industry and FDA staff. Submit comments by 20 December 2022.
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Human Gene Therapy for Neurodegenerative Diseases
On 21 October 2022 the FDA published the final guidance on developing human gene therapy for neurodegenerative diseases.
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Multiple Endpoints in Clinical Trials
On 21 October 2022 the FDA published the final guidance on multiple endpoints in clinical trials for industry.
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Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
On 31 October 2022 the FDA published the draft guidance on measuring and recording growth and evaluating pubertal development in pediatric clinical trials for industry.
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Quick Guide - Part I & Part II: How to Evaluate a Clinical Trial Application: Assessment and Decision - CTIS Training Program - Module 08
On 24 October 2022 the EMA published the quick guide parts I & II guidance on CTIS training program of module 08, version 1.4.
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ICH Guideline, Clinical Study Protocol Template and Technical Specifications
On 26 October 2022 the EMA published Step 2b of the ICH M11 related guidelines.
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Quick Guide & FAQs: Clinical Study Reports Submission - CTIS Training Program - Module 13
On 28 October 2022 the EMA published Module 13 of the quick guide and FAQs guidance on CTIS training program.
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Swissmedic Inspects Swiss Authorized Representatives (CH-REP)
3 October 2022 — Swissmedic published the report of Swiss authorized representatives (CH-REP) inspections in the first half of 2022 to check implementation of the provisions in the market.
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ICH E19 Guideline Reaches Step 4
4 October 2022 — ICH announced that the ICH E19 guideline reached Step 4 of the ICH process.
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ICH Q5A(R2) Draft Guideline Reaches Step 2
11 October 2022 — ICH announced the ICH Q5A(R2) draft guideline reached Step 2 of the ICH process.
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Export Drugs and Medicines: Special Rules
5 October 2022 — MHRA published guidance on how to get permission to export certain drugs and medicines.
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Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland
11 October 2022 — MHRA published guidance on how the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain.
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Apply for Manufacturer or Wholesaler of Medicines Licenses
13 October 2022 — MHRA published guidance on how to apply for manufacturer and wholesale of medicines licenses.
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Medicines: Apply for a Parallel Import License
13 October 2022 — MHRA published the guidance on how to get a parallel import license.
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MORE Registrations - User Reference Guide
4 October 2022 — MHRA published the MORE registration user guide.
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FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
3 October 2022 — FDA published the final PMA guidance on effect on FDA review clock and goals under MDUFA for industry and FDA staff.
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Review of Drug Master Files (DMF) in Advance of Certain ANDA Submissions Under GDUFA
3 October 2022 — FDA published the draft guidance on Type II API DMFs under GDUFA for industry.
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Facility Readiness: Goal Date Decisions Under GDUFA
3 October 2022 — FDA published industry draft guidance on facility readiness for inspection under GDUFA. Submit comments by 6 December 2022.
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Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
3 October 2022 — FDA published final guidance on physical attributes of generic tablets and capsules for industry.
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User Fees and Refunds for Premarket Approval Applications (PMAs) and Device Biologics License Applications (BLAs)
5 October 2022 — FDA published the final guidance on user fees and refunds for PMAs and device BLAs for industry and FDA staff.
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Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments (GDUFA)
5 October 2022 — FDA published final guidance on IRs and discipline review letters under GDUFA.
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Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA
5 October 2022 — FDA published the final guidance on formal meetings between FDA and ANDA applicants for industry.
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Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
5 October 2022 — FDA published final guidance on formal meetings between FDA and ANDA applicants of complex products under generic drug user fee amendments (GDUFA) for industry.
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Competitive Generic Therapies
5 October 2022 — FDA published final guidance on competitive generic therapies for industry.
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Post Market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
6 October 2022 — FDA published the final post market surveillance guidance for industry and FDA staff.
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Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
7 October 2022 — FDA published the final PAS guidance for industry and FDA staff.
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Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
13 October 2022 — FDA published final guidance on comparability protocols for postapproval CMC changes.
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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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