Modification of the Drug Master File (DMF) Form
1 May 2023 – the Swissmedic published the modified DMF form.
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Changes to the Forms for New Authorizations of and Variations to Human and Veterinary Medicinal Products
1 May 2023 – the Swissmedic published information on study design and data sources of RWE in application forms.
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Changes to the Guidance Document GMP Compliance by Foreign Manufacturers and the Form Declaration by the Responsible Person for Foreign Manufacturers
1 May 2023 – the Swissmedic published updated guidance documents on clarification of the requirements for the submission of audit reports.
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Medical Devices Swissmedic Hospital Inspections 2021/2022 Annual Report
12 May 2023 – the Swissmedic published the 2021/2022 annual report of the Swissmedic Hospital Inspections on Medical Devices.
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ICH E6(R3) Good Clinical Practice Guidance – Step 2 Public Consultation
2 May 2023 – the UK MHRA Inspectorate announced Step 2 – Public Consultation – of the ICH GCP guidance.
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Notify the MHRA about a Clinical Investigation for a Medical Device
11 May 2023 – the UK MHRA published updated guidance on notifying the MHRA of a clinical investigation for a medical device.
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Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF)
11 May 2023 – the UK MHRA published updated guidance on pharmacovigilance system requirements.
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Register Medical Devices to Place on the Market
15 May 2023 – the UK MHRA published the updated guidance on registering medical devices to place on the market.
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Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System
15 May 2023 – the UK MHRA published guidance on reporting adverse incidents involving software as a medical device.
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Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products
1 May 2023 – the FDA published final guidance on developing nicotine replacement therapy drug products.
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ICH S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
1 May 2023 – the FDA published the final ICH S12 guidance on nonclinical biodistribution (BD) studies for gene therapy (GT) products.
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Study Data Technical Conformance Guide – Technical Specifications Document
1 May 2023 – the FDA published final guidance on the study data on technical conformance for the electronic submission.
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Decentralized Clinical Trials for Drugs, Biological Products and Devices
3 May 2023 – the FDA published draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. Submit comments by 1 August 2023.
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FDA Guidance on ICH Q9(R1) Quality Risk Management
3 May 2023 – the FDA published final guidance on the ICH Q9(R1) quality risk management.
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Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products
11 May 2023 – the FDA published final guidance on the recommendations for evaluating donor eligibility using individual risk-based questions.
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Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components
11 May 2023 – the FDA published final guidance on implementing the full-length and abbreviated donor history questionnaires and accompanying materials.
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Commission Guidance on the Content and Structure of the Summary of the Clinical Investigation Report
8 May 2023 – the Official Journal of the European Union published the summary document on the clinical investigation report for the medical device.
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Interim Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information While Using the Clinical Trials Information System (CTIS)
3 May 2023 – the EMA published version 1.0 of the interim guidance on protecting personal data and confidential information while using the CTIS.
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Concept Paper on Revision of the Guideline on Clinical Investigation of Medicinal Products in the Treatment of Patients with Acute Respiratory Distress Syndrome (ARDS)
4 May 2023 – the EMA proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome. Submit comments by 31 July 2023.
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IRIS Guide to Registration and RPIs
12 May 2023 – the EMA published version 2.14 of the IRIS guide for all submissions, including substance and Research Product Identifier registration.
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Electronic Application Form (eAF) – Product Management Service (PMS) Newsletter
15 May 2023 – the EMA published Issue 3 of the eAF–PMS newsletter.
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MORE Platform Application Programming Interface (API) Integration
24 April 2023 – the UK MHRA published the instructions and reference guides for integrating with the new production MORE platform API.
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Swissmedic Becomes an Official Observer in the International Medical Devices Regulators Forum (IMDRF)
24 April 2023 – the Swissmedic announced the IMDRF granted the Swiss Agency for Therapeutic Products the status of Official Observer at Management Committee Meetings.
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Register Medical Devices to Place on the Market
27 April 2023 – the UK MHRA published updated guidance on registration of medical devices to place on the market.
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Implementation of the Future Regulations for Medical Devices
27 April 2023 – the UK MHRA published the updated guidance on the implementation of medical devices future regime.
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Regulating Medical Devices in the UK
28 April 2023 – the UK MHRA published the updated guidance on regulating medical devices in the UK and EU markets.
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Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment
19 April 2023 – the FDA published draft guidance on developing drugs for treating acute radiation syndrome. Submit comments by 19 July 2023.
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Data Standards Catalog
28 April 2023 – the FDA published version 9.1 of the final updated guidance of the data standards catalog.
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Frequently Asked Questions: Revision of the Pharmaceutical Legislation
26 April 2023 – the European Commission published Q&A guidance on the revision of the pharmaceutical legislation.
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Frequently Asked Questions: Council Recommendation on Stepping up EU Actions to Combat AMR in a One Health Approach
26 April 2023 – the European Commission published the Q&A guidance on recommendation to combat antimicrobial resistance (AMR) in one health approach.
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European Health Union: Commission Proposes Pharmaceuticals Reform for More Accessible, Affordable and Innovative Medicines
26 April 2023 – the European Commission proposes largest revision to pharmaceutical legislation in over 20 years.
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ICH S12 Guideline on Nonclinical Biodistribution Considerations for Gene Therapy Products
20 April 2023 – the EMA published step 5 of the ICH S12 guideline.
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IRIS Guide to Registration and RPIs
20 April 2023 – the EMA published version 2.14 on preliminary requirements for all IRIS submissions, including substance and Research Product Identifier (RPI) registration.
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Reflection Paper on Establishing Efficacy Based on Single-Arm Trials (SATs) Submitted as Pivotal Evidence in a Marketing Authorization
21 April 2023 – the EMA published the draft reflection paper for consideration on evidence from single-arm trials.
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EMA Pre-Authorization Guidance for Users of the Centralized Procedure
25 April 2023 – the EMA published the pre- / post-authorization guidance for users of the centralized procedure.
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Clinical Data Publication
25 April 2023 – the EMA announced resumption of publishing clinical data submitted by pharmaceutical companies.
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Biosimilar Medicines
26 April 2023 – the EMA published an updated statement and Q&A guidance on the scientific rationale supporting interchangeability of biosimilars medicines in the EU.
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News Bulletin for Small and Medium-Sized Enterprises (SME)
28 April 2023 – the EMA published SME Newsletter – Issue 58.
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Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2022
28 April 2023 – the EMA published revision 1 of the 2022 GMP/GDP IWG Annual Report.
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The ICH M7(R2) Guideline Reaches Step 4 of the ICH Process
6 April 2023 – the ICH announced ICH M7(R2) guidelines reaches step 4.
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Announcements on Clinical Trials with Medical Devices and Performance Studies with Vitro Diagnostic Medical Devices
13 April 2023 – the Swissmedic announced on submissions for combined trials with medical devices and vitro diagnostic medical devices.
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How to Draft a Direct Healthcare Professional Communication
4 April 2023 – the UK MHRA published updated guidance for marketing authorization holders on drafting direct healthcare professional communications (DHPCs).
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Software and Artificial Intelligence (AI) as a Medical Device
6 April 2023 – the UK MHRA published guidance on software and AI as a medical device.
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Good Clinical Practice for Clinical Trials
6 April 2023 – the UK MHRA published updated guidance on GCP for clinical trials.
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Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (DSF)
3 April 2023 – the FDA published the draft guidance on marketing submission recommendations for AI/ML-enabled devices. Submit comments by 3 July 2023.
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Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients (API) Under Section 506C of the FD&C Act
5 April 2023 – the FDA published draft guidance on notifications of changes in the production of finished products or API.
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Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making
5 April 2023 – the FDA published draft guidance on patient-focused drug development for industry, FDA staff and other stakeholders. Submit comments by 5 July 2023.
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Using Innovative Communication Methods to Increase Awareness and Understanding of CDER Guidance Documents: CDER’s Guidance Snapshot Pilot Program
10 April 2023 – the FDA published their Center for Drug Evaluation and Research (CDER) guidance snapshot pilot program.
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A Risk-Based Approach to Monitoring of Clinical Investigations
12 April 2023 – the FDA published final Q&A guidance on risk-based monitoring of clinical investigations for industry.
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EMA GCP IWG Points to Consider Regarding the Management of Ongoing Clinical Trials Impacted by Political Conflicts, Natural Disasters or Other Major Disruptions
5 April 2023 – the EMA published GCP IWG points to consider regarding the management of ongoing clinical trials impacted by disruptions in society.
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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 April 2023 – the EMA published the reflection paper on the use of IRTs in clinical trials.
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Clinical Trials Information System (CTIS) – Sponsor Handbook
12 April 2023 – the EMA published v3.02 of the CTIS sponsor handbook.
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New Mobile Technologies Guidance Document for Human and Veterinary Medicinal Products
1 March 2023 – the Swissmedic published regulations on the use of QR codes on packaging and in medicinal product information.
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Changes to the Guidance Document Product Information for Human Medicinal Products
1 March 2023 – the Swissmedic announced that detailed Information for healthcare professionals and Patient information templates are being withdrawn.
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ICH Electronic Common Technical Document (eCTD) v4.0
17 March 2023 – the Swissmedic published eCTD v4.0 Step 4 Implementation Package.
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Swissmedic Technical Update of CPP Order Form and New Version of the CPP Guidance Request
20 March 2023 – the Swissmedic published the updated version of the WHO pharmaceutical product (CPP) order form and the CPP guidance request.
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Swissmedic Inspects Class I Manufacturers in Switzerland
27 March 2023 – the Swissmedic published the inspection report on 27 medical devices class I manufacturers in Switzerland.
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The ICH S12 Guideline Reaches Step 4 of the ICH Process
17 March 2023 – the ICH announced the ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” reached Step 4 on 14 March 2023.
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The ICH Q9(R1) Introductory Training Presentation Available on the ICH Website
20 March 2023 – the ICH announced the ICH Q9(R1) introductory training presentation is now available on their website.
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Crafting an Intended Purpose in the Context of Software as a Medical Device (SaMD)
22 March 2023 – the UK MHRA published guidance on the context of software as a medical device.
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Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
1 March 2023 – the FDA published draft guidance on the development of monoclonal antibodies. Submit comments by 1 May 2023.
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Q13 Continuous Manufacturing (CM) of Drug Substances and Drug Products
1 March 2023 – the FDA published the final ICH Q13 guidance on the CM of drug substances and drug products.
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Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents (ARAs): Study Design, Data Analysis, and Clinical Implications
10 March 2023 – the FDA published the final guidance on the evaluation of gastric pH-dependent drug interactions with ARAs.
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Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
15 March 2023 – the FDA published draft Q&A guidance on the use of electronic systems, electronic records, and electronic signatures in clinical investigations. Submit comments by 15 May 2023.
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Development of Local Anesthetic Drug Products with Prolonged Duration of Effect
15 March 2023 – the FDA published the draft guidance on the development of local anesthetic drug products. Submit comments by 14 June 2023.
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Pharmacogenomic Data Submissions
17 March 2023 – the FDA published draft guidance on the pharmacogenomic data submissions. Submit comments by 20 June 2023.
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Electronic Systems, Electronic Records, and Electronic Signatures Webinar
22 March 2023 – the FDA scheduled a webinar to be held on 25 April 2023, on electronic systems, electronic records, and electronic signatures.
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FDA CDER & JHU CERSI Workshop | Addressing Challenges in the Design and Analysis of Rare Disease Clinical Trials: Considerations and Tools
24 March 2023 – the FDA announced a two-day virtual workshop on addressing challenges in the design and analysis of rare disease clinical trials.
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Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics
24 March 2023 – the FDA published draft guidance on the pharmacogenomic data submissions. Submit comments by 24 May 2023.
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Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions
29 March 2023 – the FDA published draft guidance on the premarket submissions for orthopedic non-spinal bone plates, screws, and washers. Submit comments by 29 May 2023.
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Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and Office for Human Research Protections (OHRP)
30 March 2023 – the FDA published draft guidance on the review of research involving children as subjects for Review Boards, Investigators, and Sponsors. Submit comments by 30 May 2023.
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Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act
30 March 2023 – the FDA published the final guidance on the cybersecurity in medical devices.
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Identification of Medicinal Products – Implementation and Use
30 March 2023 – the FDA published the final guidance on identifying medicinal products.
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Draft Qualification Opinion for Stride Velocity 95th Centile as Primary Endpoint in Studies in Ambulatory Duchenne Muscular Dystrophy Studies
1 March 2023 – the EMA published the draft qualification opinion for the Stride Velocity 95th centile (SV95C) as primary endpoint in superiority studies.
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Questions and Answers about the Raw Data Proof-of- Concept Pilot for Industry
8 March 2023 – the EMA published Q&A guidance on the scope, terms of participation and data submission process for the proof-of-concept pilot.
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Guideline on Computerized Systems and Electronic Data in Clinical Trials
10 March 2023 – the EMA published the guidance on computerized systems and electronic data in clinical trials.
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The New Unique Device Identifier (UDI) Helpdesk is Live
14 March 2023 – the European Commission (EC) announced that the new UDI helpdesk is live.
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Evaluation Guide for GMP Regulatory Compliance Program – Audit Checklist
14 March 2023 – the EMA published revision 3 of the audit checklist for the GMP regulatory compliance program.
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Clinical Trials Information System (CTIS): Virtual Walk-in Clinics
20 March 2023 – the EMA published the dates for the CTIS virtual walk-in clinics for 2023.
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EMA’s Regulatory Science Strategy to 2025
22 March 2023 – the EMA published the mid-point achievements to end 2022.
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Clinical Trials Information System (CTIS) Bitesize Talk: Document and Personal Data in CTIS
22 March 2023 – the EMA updated the presentation slides of CTIS bitesize talk on document and personal data in CTIS.
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ICH Guideline Q5A(R2) on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
27 March 2023 – the EMA updated scientific guideline on ICH Q5A(R2).
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Q&A on the Protection of Commercially Confidential Information (CCI) and Personal Data while Using CTIS
29 March 2023 – the EMA published version 1.1 of the Q&A guidance on how to protect personal data and CCI in CTIS.
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Swissmedic Journal – January 2023
6 February 2023 – the Swissmedic published the January 2023 edition of its journal.
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Applications for Clinical Trials with Medicinal Products and ATMPs (Advanced Therapy Medicinal Products)
13 February 2023 – the Swissmedic announced clinical trial applications can be submitted via new eGov portal.
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Modifications to Guidance Document "Formal Requirements"
13 February 2023 – the Swissmedic published clarification of documentation to be submitted for co-marketing medicinal products; conditions can be the subject of collective applications.
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Completed Pediatric Studies - Submission, Processing and Assessment
1 February 2023 – the UK MHRA published updated guidance on the submission, processing and assessment of all completed pediatric studies sponsored by Marketing Authorization Holders (MAHs).
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Manufacture of Investigational Medicinal Products – Frequently Asked Questions
3 February 2023 – the UK MHRA inspectorate published FAQs on manufacturing IMP.
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Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products
1 February 2023 – the FDA published draft guidance on the design and conduct of externally controlled trials. Submit comments by 2 May 2023.
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Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
10 February 2023 – the FDA published draft guidance on long-term clinical neurodevelopmental safety studies in neonatal product development.
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Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA
17 February 2023 – the FDA published draft guidance on requesting and conducting PSG meetings. Submit comments by 22 April 2023.
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Guidance for Industry and FDA Staff – Diagnostic X-Ray, Ultrasound Systems and Laser Equipment
21 February 2023 – the FDA published final guidance documents on diagnostic x-ray, ultrasound systems and laser equipment.
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Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment
24 February 2023 – the FDA published draft guidance on developing drugs for treating neovascular age-related macular degeneration. Submit comments by 30 May 2023.
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Accelerating Clinical Trials in the European Union (ACT EU)
3 February 2023 – the EMA published the priority action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials.
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IRIS Guide to Registration and RPIs
6 February 2023 – the EMA published version 2.12 of the IRIS guide to registration and RPIs.
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ICH Guideline Q9 (R1) on Quality Risk Management
6 February 2023 – the EMA published step 5 of the ICH Q9 (R1) guideline on quality risk management.
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EMA/HMA Big Data Stakeholder Forum 2022 Report
13 February 2023 – the EMA published the December 2022 Big Data Stakeholder Forum report.
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Pediatric Addendum on the Guidelines on Clinical Investigation of Medicinal Products for the Treatment and Prophylaxis of Venous Thromboembolic Disease
14 February 2023 – the EMA published the pediatric addendum of the guideline on clinical investigation for the treatment and prophylaxis of venous thromboembolic disease.
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Questions & Answers Regarding Cannabis-derived Medicinal Products and the Scope of EU Herbal Monographs for Herbal Medicinal Products within the EU Medicines Legislation
15 February 2023 – the EMA published Q&A guidance on herbal medicinal products.
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