Electronic Submission Template for Medical Device 510(k) Submissions
On 29 September 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 28 November 2021.
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Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
On 29 September 2021 the FDA published the draft guidance for industry.
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Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
On 29 September 2021 the FDA published the draft guidance for industry. Comments should be submitted by 29 November 2021.
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Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
On 29 September 2021 the FDA published the final guidance for industry.
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Benefit-Risk Assessment for New Drug and Biological Products
On 29 September 2021 the FDA published the draft guidance. Comments should be submitted by 29 November 2021.
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Clinical Trials for Medicines: Apply for Authorization in the UK
On 30 September 2021 the UK MHRA updated the guidance on how to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to the application.
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Targeted Stakeholder Consultation on the Amendments to Commission Implementing Regulation (EU) 520/2012 on Pharmacovigilance Activities
On 1 September 2021 the European Commission announced the targeted stakeholder consultation from 31 August to 15 October 2021.
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UK MHRA and US FDA Tackle Challenging Data Integrity
On 1 September 2021 the UK MHRA Inspectorate published the white paper on 2020 MHRA and FDA joint Good Clinical Practice (GCP) symposium.
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UK MHRA Updated Managing Clinical Trials During Coronavirus (COVID-19)
On 8 September 2021 the UK MHRA updated guidance on managing clinical trials during COVID-19.
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Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers
On 8 September 2021 the FDA published the final Q&A guidance for industry.
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S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 9 September 2021 the FDA published the ICH S12 draft guidance for industry.
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Technical Workshop on Real-world Metadata for Regulatory Purposes
On 9 September 2021 the EMA published the summary report of the technical workshop that took place on 12 April 2021.
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Webinar for Small and Medium-sized Enterprises (SMEs) and Academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS)
On 10 September 2021 the EMA announced a webinar for SMEs and academia on 29 November 2021.
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Updated Danish Medicines Agency’s Guidance on the Implementation of Decentralized Elements in Clinical Trials with Medicinal Products
On 10 September 2021 the Danish Medicines Agency announced the availability of the updated guidance version 2.0.
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Detailed Guidance on the Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorization Holders to the European Medicines Agency in accordance with Article 57(2) of Regulation (EC) No. 726/2004
On 14 September 2021 the EMA updated the extended EudraVigilance Medicinal Product Report Message (XEVPRM) user guidance.
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Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products - General Principles
On 15 September 2021 the EMA published the EMA-FDA PSA program.
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Guidance for Notified Bodies, Distributors and Importers on Certification Activities in Accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
In August 2021 the Medical Device Coordination Group (MDCG) published guidance of MDCG 2021-23.
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DAIDS Good Clinical Laboratory Practice Guidelines
On 16 August 2021 the Division of AIDS (DAIDS) in the U.S. National Institute of Allergy and Infectious Diseases (NIAID) published the GCLP guidelines.
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General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)
On 18 August 2021 the EMA published updated general principles on EMA-FDA parallel scientific advice.
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Australian Therapeutic Goods Administration (TGA) Reduces Timeframe for Publishing Adverse Event Reports
On 19 August 2021 the TGA announced a reduced timeframe for publishing adverse event reports.
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Notifying FDA of Fatalities Related to Blood Collection or Transfusion
On 20 August 2021 the FDA announced updated guidance for industry.
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FDA Export Certification
On 20 August 2021 the FDA published the final guidance for industry.
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Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
On 20 August 2021 the FDA published the draft guidance for industry.
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Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
On 25 August 2021 the FDA published the draft guidance for industry.
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FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
On 30 August 2021 the FDA published updated guidance for industry, investigators, and Institutional Review Boards.
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Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
On 31 August 2021 the FDA published the final guidance on technical specifications document for industry.
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Clinical Trials Regulation (EU) No 536/2014 Draft
Questions & Answers Version 4
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Six-month Countdown to Go-live for the Clinical Trials Information System (CTIS)
On 2 August 2021 the EMA announced six-month countdown to go-live for the CTIS.
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Belgium - Updated Guidance on Submissions re CTAs, Substantial Amendments, and End-of-trial Declaration
On 5 August 2021 the Belgium FAMHP updated the guidance on the submission of clinical trial applications.
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Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials
On 6 August 2021 the FDA published the final guidance on considerations for metastasis-free survival endpoint in clinical trials.
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Development and Submission of Near Infrared Analytical Procedures
On 6 August 2021 the FDA published the final guidance on the development and submission of near infrared analytical procedures.
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Clinical Trials Information System (CTIS) Highlights
On 6 August 2021 the EMA published the issue 4 of the CTIS highlights newsletter from August 2021.
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Regulatory Changes for Software Based Medical Devices
On 9 August 2021 the Australian Therapeutic Goods Administration (TGA) published the guidance on regulatory changes for software based medical devices.
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Clinical Researchers Sentenced in Connection with Scheme to Falsify Drug Trial Data
On 11 August 2021 the US Department of Justice sentenced clinical researchers in connection with scheme to falsify clinical drug trial data.
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Transfer of Analytical Methods
On 13 August 2021 the article was published on the MHRA inspectorate blog.
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Updated Records of Clinical Trials Information System (CTIS) Webinar about How Sponsor Organisations can Prepare for CTIS
On 13 August 2021 the EMA updated the records of the CTIS webinar event.
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Guidance on Paediatric Submissions: Via eSubmission Gateway and eSubmission Web Client
On 19 July 2021 the EMA announced the availability of the guidance on paediatric eSubmssion.
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Field Alert Report Submission: Questions and Answers
On 22 July 2021 the FDA published the final Q&A guidance on filed alert report submission for industry.
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Guideline on Quality Documentation for Medicinal Products When Used with a Medical Device
On 23 July 2021 the EMA published the guideline on product-specific quality aspects of a medical device.
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Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
On 23 July 2021 the EMA published the reflection paper on GMP and the responsibilities of MAHs.
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Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis
On 28 July 2021 the FDA published the draft guidance. Comments may be submitted by 27 October 2021.
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Clinical Trial Information System (CTIS) - Sponsor Handbook
On 29 July 2021 the EMA announced the availability of the handbook to help clinical trial sponsors preparing for using CTIS.
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ICH Guideline Q13 on Continuous Manufacturing of Drug Substances and Drug Products
On 29 July 2021 the ICH published the Q13 draft guideline.
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Commission Decision (EU) 2021/1240 of 13 July 2021 on the Compliance of the EU Portal and the EU Database for Clinical Trials of Medicinal Products for Human Use with the Requirements Referred to in Article 82(2) of Regulation (EU) No 536/2014 of the Euro
On 31 July 2021 the published the EU commission decision of 13 July 2021 on the compliance of EU portal and EU database for clinical trials.
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Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments
On 1 July 2021 the PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PI 041-1) entered into force.
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Guideline on the Requirements for Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
On 1 July 2021 the EMA published the draft guideline.
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Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
On 1 July 2021 the EMA published the draft guideline, revision 2.
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Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
On 1 July 2021 the FDA published the final guidance for industry.
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Providing Regulatory Submissions in Alternate Electronic Format
On 1 July 2021 the FDA announced the availability of the final guidance for industry.
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Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
On 1 July 2021 the FDA published the draft guidance for industry.
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MHRA Delivery Plan 2021-2023 – Putting Patients First: A New Era for Our Agency
On 5 July 2021 the UK MHRA published its delivery plan for 2021-2023.
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FAQs: Supervise a Clinical Trial Inspection Records: CTIS Training Programme – Module 16
On 6 July 2021 the EMA published the Q&A document regarding module 16 of clinical trial inspection records.
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Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI)
On 7 July 2021 the FDA published the final guidance for industry and FDA staff.
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Authorisations and Procedures Required for Importing Investigational Medicinal Products to Great Britain from Approved Countries
On 7 July 2021 the UK MHRA updated the guidance on authorisation and procedure requirements for importing IMPs to the UK.
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Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations can Prepare for CTIS
On 14 July 2021 the EMA updated the CTIS webinar information.
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Combined Review to Facilitate Speedier Set Up for Clinical Research Trials
On 15 July 2021 the UK MHRA announced it will publish a combined review of all new clinical trials of IMPs in the UK beginning January 2022.
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Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 17 June 2021 the FDA published the final guidance for industry.
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Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products
On 21 June 2021 the FDA published the final guidance for industry.
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Providing Regulatory Submissions in Electronic Format – Standardized Study Data
On 22 June 2021 the FDA published the final guidance for industry.
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Access Consortium Strategic Plan 2021-2024
On 22 June 2021 the Access consortium (comprising the national regulatory authorities of Australia, Canada, Singapore, Switzerland, and the UK) published its Strategic Plan 2021-2024.
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Clinical Trials Information System (CTIS) Highlights – June 2021
On 23 June 2021 the EMA published Issue 3 of the CTIS newsletter.
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Remanufacturing of Medical Devices
On 24 June 2021 the FDA published the draft guidance for industry and FDA staff. Comments should be submitted by 23 August 2021.
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Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings
On 24 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 August 2021.
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Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
On 25 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 September 2021.
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Questions & Answers for Applicants, Marketing Authorization Holders of Medicinal Products and Notified Bodies with Respect to the Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/745 and (EU) 2017/746)
On 29 June 2021 the EMA published the Q&A guidance on implementation of the medical devices and in vitro diagnostic medical devices regulations.
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Product Management Services – Implementation of International Organization for Standardization (ISO) Standards for the Identification of Medicinal Products (IDMP) in Europe
On 30 June 2021 the EMA published the guidance on ISO implementation for the IDMP in Europe.
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Product Identifiers under the Drug Supply Chain Security Act — Questions and Answers
On 3 June 2021 the FDA announced the availability of the final Q&A guidance for industry.
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Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations Can Prepare for CTIS
On 7 June 2021 the EMA announced a CTIS webinar which will take place on 29 July 2021.
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Clinical Researchers Plead Guilty in Connection with Scheme to Falsify Drug Trial Data
On 8 June 2021 the US Department of Justice released update on clinical researchers’ clinical trial data scheme.
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Core Patient-Reported Outcomes in Cancer Clinical Trials
On 9 June 2021 the FDA published the draft guidance. Comments should be submitted by 9 August 2021.
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Frequently Asked Questions about Parallel Distribution
On 9 June 2021 the EMA published the Q&A guidance on parallel distribution.
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CIOMS Cumulative Pharmacovigilance Glossary
In June 2021 the CIOMS published the pharmacovigilance glossary V1.1.
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EMA Annual Report 2020 Published
On 14 June 2021 the EMA published its 2020 annual report.
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COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention
On 17 May 2021 the FDA issued this final guidance for industry.
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Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers
On 17 May 2021 the FDA issued this Q&A guidance for industry.
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Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention
On 19 May 2021 the FDA published this draft guidance for industry. Comments should be submitted by 19 July 2021.
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Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
On 19 May 2021 the FDA published this final guidance for industry and FDA staff.
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Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs
On 19 May 2021 the FDA published the draft guidance on questions regarding the Statement of Investigator Form 1572.
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ICH Q12: Implementation Considerations for FDA-Regulated Products
On 19 May 2021 the FDA published this draft guidance on the International Council for Harmonization (ICH) Q12 for industry.
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Conveying Medical Device Materials Information to Patients and Clinicians: Considerations for a Framework
On 20 May 2021 the FDA published the discussion paper on conveying information about medical device materials.
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Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
On 20 May 2021 the FDA published this draft guidance for industry.
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Bispecific Antibody Development Programs
On 24 May 2021 the FDA published this final guidance for industry.
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Notify the MHRA about a Clinical Investigation for a Medical Device
On 25 May 2021 the MHRA updated the guidance on notifying the MHRA of a proposed clinical investigation for a medical device.
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EU Medical Device Regulation Comes into Application
On 26 May 2021 the EMA announced that the Regulation (EU) 2017/745 on medical devices became applicable in the EU.
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Guidance Notes on the Management of Safety Information and Product Complaints Digital Activities
On 27 April 2021 the Association of the British Pharmaceutical Industry (ABPI) published the informal guidance notes.
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The Danish Medicines Agency’s Guidance on the Implementation of Decentralised Elements in Clinical Trials with Medicinal Products
On 4 May 2021 the Danish Medicines Agency published the guidance on decentralised clinical trials.
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FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
On 5 May 2021 the FDA published its Resiliency Roadmap for FDA Inspectional Oversight.
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MHRA Guidance on the Licensing of Biosimilar Products
On 6 May 2021 the UK MHRA published the guidance on the licensing of biosimilar products.
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Is Your eSystem Actually an eCRF (electronic Case Report Form)?
On 11 May 2021 the MHRA Inspectorate published this blog.
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Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
On 11 May 2021 the FDA published this final guidance for industry.
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Operational Application Programming Interface: Downloading Content for Analysis
On 11 May 2021 ClinicalTrials.gov announced the availability of operational API.
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Study Coordinator Charged in Scheme to Falsify Clinical Trial Data
On 11 May 2021 a US Department of Justice federal grand jury returned an indictment charging conspiracy to falsify clinical trial data.
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Draft Principles of ICH E6 Good Clinical Practice (GCP) now Available
On 19 April 2021 the ICH announced the availability of the draft principles of ICH E6 GCP.
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CDISC CDASH SAE Supplement v2.0 Released
On 21 April 2021 the CDISC announced the release of the CDASH SAE Supplement version 2.0.
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Request for Proposals for Auditors to Support Audits of MedDRA MSSO Operations
On 21 April 2021 the ICH launched a request for proposal for auditors in support of MedDRA MSSO audits.
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Clinical Trials Information System Reaches Major Milestone towards Go-Live and Application of the Clinical Trial Regulation
On 21 April 2021 the EMA announced that the CTIS is on track to go live with the application of Clinical Trial Regulation.
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Questions and Answers on the Principles of GMP for the Manufacturing of Starting Materials of Biological Origin Used to Transfer Genetic Material for the Manufacturing of ATMPs
On 23 April 2021 the EMA announced the availability of the updated Q&A guidance on GMP.
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The ICH Q3C(R8) Guideline Reaches Step 4 of the ICH Process
On 23 April 2021 the ICH announced the status of the maintenance process for the ICHQ3C(R8) guideline.
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Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases
On 26 April 2021 the FDA published draft guidance for sponsor-investigators.
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