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  • 16 May 2022
  • 457
Updated Good Clinical Practice (GCP) Inspection Procedures
On 5 May 2022 the EMA announced the updates of the guidance on GCP inspection procedures.
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  • 16 May 2022
  • 457
Guidelines on MedDRA Coding for Drug Marketing Authorization Holders
On 6 May 2022 the Chinese NMPA issued the MedDRA coding guidelines for the MAHs.
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  • 16 May 2022
  • 463
Compliance Monitor Process (Part 2) – CM Role and Application Process
On 10 May 2022 the UK MHRA Inspectorate published the second part of the compliance monitor process.
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  • 16 May 2022
  • 439
Benefit-Risk Considerations for Product Quality Assessments
On 10 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 10 July 2022.
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  • 05 May 2022
  • 512
NMPA Guidelines for Pharmacovigilance Inspection
On 15 April 2022 the Chinese NMPA published the announcement of distributing the PV inspection guidelines (NMPA [2022] No. 17).
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  • 05 May 2022
  • 606
Annual Report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2021
On 20 April 2022 the EMA published annual report of the GMP/GDP Inspectors Working Group (IWG).
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  • 05 May 2022
  • 988
Overview of Comments Received on ICH Guideline Q9 (R1) on Quality Risk Management
On 20 April 2022 the EMA published comments on ICH guideline Q9(R1) on quality risk management.
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  • 05 May 2022
  • 494
2021 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission
On 20 April 2022 the EMA published the 2021 EudraVigilance annual report (1 Jan to 31 Jan 2021).
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  • 05 May 2022
  • 641
Compilation of Union Procedures on Inspections and Exchange of Information
On 20 April 2022 the EMA published the compilation of union procedures on inspections and exchange of information.
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  • 05 May 2022
  • 475
PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities
On 21 April 2022 the EMA issued PV guidance revision 2 on the Pharmacovigilance Risk Assessment Committee (PRAC) strategy.
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  • 05 May 2022
  • 619
Refuse to Accept Policy for 510(k)s
On 21 April 2022 the FDA published the final guidance for industry and FDA staff.
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  • 05 May 2022
  • 497
Drug Products, Including Biological Products, that Contain Nanomaterials
On 21 April 2022 the FDA published the final guidance for industry on drug products with nanomaterials.
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  • 05 May 2022
  • 428
Providing Submissions in Electronic Format — Postmarketing Safety Reports
On 27 April 2022 the FDA published the final guidance on electronic submissions of postmarketing safety reports for industry.
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  • 05 May 2022
  • 498
ICH E8(R1) General Considerations for Clinical Studies
On 28 April 2022 the ICH announced that Step 4 - Introductory Training Presentation – is available on the ICH website.
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  • 05 May 2022
  • 489
Compliance Monitor (CM) Overview and Application Process
On 29 April 2022 the UK MHRA published guidance on the CM overview and application process.
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  • 19 April 2022
  • 697
Update to Guidance document "Information on PSUR / PBRER submission"
Effective 1 April 2022, Swissmedic updated the Guidance document, allowing a transition period of 30 days.
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  • 19 April 2022
  • 467
Good Clinical Practice for Medical Devices
On 2 April 2022 the Chinese NMPA issued an announcement for the GMP for clinical trials of medical devices (No. 28 of 2022).
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  • 19 April 2022
  • 658
Guidance for Applicants/MAHs Involved in GMP and GCP Inspections Coordinated by EMA
On 2 April 2022 the EMA published guidance for applicants/MAHs involved in GMP and GCP inspections.
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  • 19 April 2022
  • 535
M7(R2) Addendum: Application of The Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes
On 6 April 2022 the FDA published draft guidance on ICH M7 addendum for industry.
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  • 19 April 2022
  • 459
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment
On 6 April 2022 the FDA published the final guidance on developing drugs for chronic hepatitis B virus infection.
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  • 19 April 2022
  • 526
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers
On 7 April 2022 the FDA published the draft Q&A guidance for industry. Comments may be submitted until 7 Jun 2022.
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  • 19 April 2022
  • 489
General Considerations for Clinical Studies – E8(R1)
On 7 April 2022 the FDA published the final guidance on ICH E8(R1) general considerations for clinical studies.
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  • 19 April 2022
  • 551
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
On 8 April 2022 the FDA published draft guidance on cybersecurity in medical devices for industry and FDA staff. Comments may be submitted until 7 Jul 2022.
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  • 19 April 2022
  • 759
Draft Guidance Document on How to Approach the Protection of Personal Data and Commercially Confidential Information in Documents Uploaded and Published in the Clinical Trial Information System (CTIS)
On 8 April 2022 the EMA published draft guidance on protection of personal data and commercially confidential information in CTIS.
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  • 19 April 2022
  • 456
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
On 11 April 2022 the FDA published the final guidance for industry.
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  • 19 April 2022
  • 636
Updated Frequently Asked Questions about Parallel Distribution
On 12 April 2022 the EMA updated the FAQ/General Question No. 22.
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  • 19 April 2022
  • 483
Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
On 13 April 2022 the FDA announced the availability of the draft guidance for industry.
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  • 19 April 2022
  • 476
Updated IRIS Guide for Applicants
On 13 April 2022 the EMA published version 2.8 of the IRIS guide on how to create and submit scientific applications, for industry and individual applicants.
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  • 19 April 2022
  • 501
Questions and Answers Document – Regulation (EU) 536/2014
On 13 April 2022 the European Commission published Q&A guidance on Clinical Trials Regulation (EU) 536/2014, version 6.
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  • 19 April 2022
  • 486
Detailed Guidance on ICSRs in the Context of COVID-19
On 13 April 2022 the EMA published updated guidance revision 3, clarifying the validity and coding of ICSRs linked to COVID-19.
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  • 19 April 2022
  • 464
Points to Consider on the Impact of the War in Ukraine on Methodological Aspects of Ongoing Clinical Trials
On 13 April 2022 the EMA published guidance on actions for ongoing clinical trials affected by the war in Ukraine.
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  • 19 April 2022
  • 507
Bioavailability Studies Submitted in NDAs or INDs – General Considerations
On 14 April 2022 the FDA published final guidance on general considerations for bioavailability studies submitted in NDAs or INDs.
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  • 01 April 2022
  • 715
Updated EMA EudraVigilance Registration Manual
On 17 March 2022 the EMA updated the EudraVigilance registration manual.
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  • 01 April 2022
  • 502
Updated EMA Post-authorization Procedural Advice for Users of the Centralized Procedure
On 18 March 2022 the EMA updated the EudraVigilance registration manual.
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  • 01 April 2022
  • 819
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4
On 22 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 640
An Acceptable Circular of Information for the Use of Human Blood and Blood Components
On 22 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 497
"Measures for the Supervision and Administration of Medical Device Production" and "Measures for the Supervision and Administration of Medical Device Operation"
On 23 March 2022 the Chinese NMPA published two guidelines on medical device production and operation.
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  • 01 April 2022
  • 799
Announcement on the Release of Guidelines for the Preparation of Annual Self-inspection Reports for Medical Device Quality Management Systems (No. 13 of 2022)
On 24 March 2022 the Chinese NMPA announced the release of guidelines on annual self-inspection reports for medical device quality management systems effective 1 May 2022.
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  • 01 April 2022
  • 597
ICH Guideline E14/S7B: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Q&A Step 5
On 24 March 2022 the EMA published the ICH Q&A guideline E14/S7B.
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  • 01 April 2022
  • 546
Emergency Use Authorization for Vaccines to Prevent COVID-19
On 31 March 2022 the FDA published final guidance for industry.
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  • 01 April 2022
  • 545
Clinical Trials in Human Medicines: Management of Clinical Trials Impacted by the War in Ukraine
On 31 March 2022 the FDA published the advice to sponsors on management of clinical trials impacted by the war in Ukraine.
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  • 21 March 2022
  • 506
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
On 1 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 542
Pre-Launch Activities Importation Requests (PLAIR)
On 1 March 2022 the FDA published the final guidance on the PLAIR for industry.
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  • 21 March 2022
  • 482
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
On 1 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 465
Inclusion of Older Adults in Cancer Clinical Trials
On 2 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 534
Unique Identification Number (CHRN – Swiss Single Registration Number)
On 3 March 2022 the Swissmedic updated the guidance on the unique Swiss Single Registration Number for medical devices.
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  • 21 March 2022
  • 517
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs
On 9 March 2022 the FDA published draft guidance for industry. Comments may be submitted until 9 May 2022.
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  • 21 March 2022
  • 582
Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions
On 11 March 2022 the FDA published the final guidance for industry.
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  • 21 March 2022
  • 560
Compliance Monitor Process (Part 1) – An Introduction
On 11 March 2022 the MHRA Inspectorate Blog published part one of a two-part series on the Compliance Monitor Process.
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  • 21 March 2022
  • 489
Updated Guidelines on Good Pharmacovigilance Practices (GVP)
On 14 March 2022 the EMA issued an introductory cover note updating the release of Addendum III of Module XVI on pregnancy prevention programs for public consultation.
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  • 21 March 2022
  • 542
Human Gene Therapy Products Incorporating Human Genome Editing
On 15 March 2022 the FDA published draft guidance for industry.
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  • 21 March 2022
  • 564
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products
On 15 March 2022 the FDA published draft guidance for industry.
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  • 21 March 2022
  • 543
EudraVigilance – EVWEB User Manual
On 15 March 2022 the EMA updated section 5.1 of the EVWEB reporting tool user manual.
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  • 21 March 2022
  • 595
Updated EMA Q&A: Good Clinical Practice (GCP)
On 15 March 2022 the EMA updated the GCP Q&A guidance.
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  • 04 March 2022
  • 515
Updated Clinical Pharmacology and Pharmacokinetics: Questions and Answers
On 16 February 2022 the EMA published updated Q&A guidance on expectations for bootstrapping to calculate the 90% confidence interval for the f2 similarity factor.
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  • 04 March 2022
  • 796
Eudralex Volume 4 – EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
On 21 February 2022 the European Commission published Annex 21 of Eudralex Volume 4 EU guideline for GMP.
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  • 04 March 2022
  • 530
FDA Issues Proposal to Amend Medical Device Quality System Regulations
On 23 February 2022 the FDA issued an amendment proposal for medical device regulation. Comments on the proposed rule may be submitted until 24 May 2022. Comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 are accepted until 25 March 2022.
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  • 04 March 2022
  • 530
Updated EudraVigilance – EVWEB User Manual
On 23 February 2022 the EMA published version 1.6 of the EVWEB web reporting tool.
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  • 04 March 2022
  • 508
European Medicines Agency Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 24 February 2022 the EMA published the updated guidance for scientific advice or protocol assistance procedures.
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  • 04 March 2022
  • 501
Patient-Focused Drug Development: Methods to Identify What Is Important to Patients
On 25 February 2022 the FDA published the final guidance for Industry, FDA staff and other stakeholders.
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  • 04 March 2022
  • 563
NMPA Guidance on Preparation of Pharmacovigilance
On 25 February 2022 the Center for Drug Reevaluation of Chinese NMPA published the notification on PSMF preparation guidance.
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  • 04 March 2022
  • 528
Procedural Advice – Extended Assessment Time for Initial Marketing Authorization Applications of 90 Days
On 25 February 2022 the EMA published the extended assessment time for initial marketing authorization applications.
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  • 22 February 2022
  • 691
Updated Questions and Answers Document – Clinical Trials Regulation (EU) 536/2014
On 1 February 2022 the European Commission published version 5 (January 2022) of the updated Q&A guidance on the Clinical Trials Regulation.
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  • 22 February 2022
  • 732
Clinical Trials Information System (CTIS): Updated Online Modular Training Program
On 3 February 2022 the EMA announced the availability of version 1.1 of online modular CTIS training program.
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  • 22 February 2022
  • 565
EudraVigilance: Obtaining EDQM terms from SPOR
On 3 February 2022 the EMA published the EudraVigilance guidance on obtaining EDQM terms from SPOR.
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  • 22 February 2022
  • 709
Mandatory Use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for Dosage Forms (DF) and Routes of Administration (RoA)
On 3 February 2022 the EMA published guidance on the mandatory use of ISO ICSR/ICH E2B(R3) and EDQM Terminology for DF and RoA.
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  • 22 February 2022
  • 633
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling–Content and Format
On 3 February 2022 the FDA published the draft guidance for industry. Comments accepted until 5 April 2022.
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  • 22 February 2022
  • 589
Assessment of Pressor Effects of Drugs
On 3 February 2022 the FDA published the draft guidance for industry.
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  • 22 February 2022
  • 755
Population Pharmacokinetics
On 3 February 2022 the FDA published the final guidance for industry.
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  • 22 February 2022
  • 647
Drug Product Tracing: The Effect of Section 585 of the FD&C Act
On 3 February 2022 the FDA published the final guidance on the Q&A.
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  • 22 February 2022
  • 525
Updated 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
On 4 February 2022 the EMA announced the new version of the reflection paper on the use of IRTs in clinical trials.
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  • 22 February 2022
  • 598
Update – Guideline on the Requirements to Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials
On 4 February 2022 the European Commission announced the revision 2 on the requirements for quality documentation of chemical and pharmaceutical IMPs in clinical trials.
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  • 22 February 2022
  • 502
Update – Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
On 4 February 2022 the European Commission announced revision 2 on the requirements for quality documentation of biological IMPs in clinical trials.
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  • 22 February 2022
  • 591
Clinical Pharmacology Considerations for Antibody-Drug Conjugates
On 7 February 2022 the FDA published the draft guidance. Comments accepted through 6 May 2022.
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  • 22 February 2022
  • 523
Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland
On 7 February 2022 the MHRA updated guidance on how to implement the ‘Written Confirmation’ process for active substances manufactured in Great Britain.
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  • 22 February 2022
  • 548
Clinical Trials for Medicines: Manage your Authorization, Report Safety Issues
On 7 February 2022 the MHRA updated the guidance on managing the clinical trial authorization, reporting safety issues and completing the end-of-trial study report.
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  • 22 February 2022
  • 523
Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
On 7 February 2022 the European Commission announced an update of the joint implementation plan for IVDR.
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  • 22 February 2022
  • 536
Updated IRIS Guide for Applicants
On 7 February 2022 the EMA issued version 2.6 of the IRIS guide for applicants.
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  • 22 February 2022
  • 466
Initiation of DARWIN EU® Coordination Centre Advances Integration of Real-World Evidence into Assessment of Medicines in the EU
On 9 February 2022 the EMA announced the establishment of the Coordination Centre with Erasmus University Medical Center Rotterdam for the DARWIN EU.
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  • 22 February 2022
  • 527
Updated Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic
On 10 February 2022 the European Commission announced the updated guidance on the clinical trials management during the COVID-19 pandemic in Europa.
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  • 22 February 2022
  • 630
Update to Guidance Document: Risk Management Plan (RMP) ICH E2E Information for HMP Submission
On 15 February 2022 the Swissmedic announced the updated guidance on RMP ICH E2E submission information for human medicinal products.
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  • 22 February 2022
  • 696
Big Data Highlights – Issue 1
On 15 February 2022 the EMA published the first edition of the newsletter on Big Data.
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  • 22 February 2022
  • 555
EudraVigilance: Updated Electronic Reporting
On 15 February 2022 the EMA announced an update to electronic reporting in EudraVigilance.
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  • 02 February 2022
  • 769
Clinical Trials Information System (CTIS) Sponsor End User Training Program – March 2022
On 18 January 2022 the EMA announced the CTIS sponsor end user training program being held from 1 March to 4 March 2022, for the new way of submitting, managing and reporting a clinical trial via the CTIS.
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  • 02 February 2022
  • 590
Electronic Application Form (eAF) and Cover Letter Tool
On 20 January 2022 the MHRA updated the guidance on how to complete the eAF and cover letter.
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  • 02 February 2022
  • 592
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
On 21 January 2022 the FDA published the draft guidance for industry, investigators, and other stakeholders. Comments may be submitted until 22 March 2022.
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  • 02 February 2022
  • 595
Regulatory Harmonization of Clinical Trials in the EU: Clinical Trials Regulation to Enter into Application and new Clinical Trials Information System (CTIS) to be Launched
On 25 January 2022 the EMA released the news about the CTIS launching on 31 January 2022.
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  • 02 February 2022
  • 602
Revising ANDA Labeling Following Revision of the RLD Labeling
On 25 January 2022 the FDA published the draft guidance for industry. Comments may be submitted until 25 March 2022.
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  • 02 February 2022
  • 709
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies
On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 February 2022
  • 598
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.
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  • 02 February 2022
  • 587
Principles of Premarket Pathways for Combination Products
On 26 January 2022 the FDA issued the final guidance for industry and FDA staff.
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  • 02 February 2022
  • 623
Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments
On 26 January 2022 the FDA issued the final guidance for industry.
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  • 02 February 2022
  • 580
Good ANDA Submission Practices
On 26 January 2022 the FDA issued the final guidance for industry.
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  • 02 February 2022
  • 678
Oversight and Monitoring of Investigational Medical Product (IMP) Trials
On 28 January 2022 the MHRA issued guidance to assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of IMPs.
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  • 02 February 2022
  • 530
Risk-Adapted Approach to Clinical Trials and Risk Assessments
On 28 January 2022 the MHRA issued guidance on how to implement a dual strategy for a risk-adapted approach to clinical trials in the UK.
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  • 02 February 2022
  • 551
Guideline on Requirements for Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products (IMPs) in Clinical Trials
On 28 January 2022 the EMA published guidance to define harmonized requirements for documentation submitted throughout the EU.
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  • 19 January 2022
  • 1109
Regulating Medical Devices in the UK
On 1 January 2022 the MHRA updated this guidance to reflect changes to the new medical device regulatory requirements.
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  • 19 January 2022
  • 561
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Training
On 4 January 2022 the EMA updated the frequently asked questions about XEVMPD training.
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  • 19 January 2022
  • 597
Notify the MHRA about a Clinical Investigation for a Medical Device
On 4 January 2022 the MHRA updated the guidance on how to inform them of a clinical investigation of medical devices.
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  • 19 January 2022
  • 565
Investigational COVID-19 Convalescent Plasma
On 7 January 2022 the FDA published the final guidance for industry.
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SOP Management and Re-engineering

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