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  • 05 September 2022
  • 298
E11A Pediatric Extrapolation
On 26 August 2022 the FDA published draft guidance on ICH E11A.
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  • 05 September 2022
  • 309
Guidance for Applicants/MAHs Involved in GMP, GCP and GVP Inspections Coordinated by EMA
On 31 August 2022 the EMA published guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, version 3.0.
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  • 26 August 2022
  • 404
Changes to Guidance Document Authorization Procedures for COVID-19 Medicinal Products During a Pandemic HMV4
1 August 2022 — Swissmedic published the revised guidance document effective 1 August 2022.
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  • 26 August 2022
  • 330
Digital Application Dataset Integration (DADI) Q&A Webinar - Variations Form for Human Medicinal Products
2 August 2022 — EMA published the DADI Q&A webinar summary document.
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  • 26 August 2022
  • 342
News Bulletin for Small and Medium-Sized Enterprises (SME)
2 August 2022 — EMA published Issue 56 of the SME Office Newsletter.
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  • 26 August 2022
  • 308
Application for Priority Applicant Determination - Medical Devices
2 August 2022 — Australian Therapeutic Goods Administration (TGA) announced the availability of the application form for priority applicant determination of medical devices.
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  • 26 August 2022
  • 361
Version 2.8 of Technical Documentation - UDI/Devices Registration
2 August 2022 — European Commission published the technical documentation version 2.8 for unique device identifier (UDI)/Devices registration.
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  • 26 August 2022
  • 285
Clinical Trials for Medicines: Manage Your Authorization, Report Safety Issues
2 August 2022 — MHRA updated the guidance on clinical trials for medicines.
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  • 26 August 2022
  • 299
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
2 August 2022 — FDA published draft guidance for industry. Submit comments by 3 October 2022.
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  • 26 August 2022
  • 306
EMA Initiatives for Acceleration of Development Support and Evaluation Procedures for COVID-19 Treatments and Vaccines
3 August 2022 — EMA published guidance on rapid formal review procedures related to COVID-19.
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  • 26 August 2022
  • 328
Decommission of eSUSAR
3 August 2022 — MHRA inspectorate announced decommission of eSUSAR.
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  • 26 August 2022
  • 320
Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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  • 26 August 2022
  • 360
Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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  • 26 August 2022
  • 324
IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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  • 26 August 2022
  • 316
EVVet3 Production - Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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  • 26 August 2022
  • 311
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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  • 26 August 2022
  • 369
Complex Generics News
5 August 2022 — FDA published up-to-date information on FDA’s actions on complex generics.
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  • 26 August 2022
  • 322
Bioresearch Monitoring Technical Conformance Guide
5 August 2022 — FDA published technical specifications guidance on bioresearch monitoring technical conformance guide.
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  • 26 August 2022
  • 293
IRIS for Good Pharmacovigilance Practice (GVP) Inspections Training Session for Industry Users
9 August 2022 — EMA announced the GVP inspections training session on 7 September 2022.
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  • 26 August 2022
  • 322
EVVet3 Production – Release Notes
8 August 2022 — EMA published v1.6 release notes of EVVet3.
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  • 26 August 2022
  • 277
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products
15 August 2022 — FDA published the technical specifications document of the final E2B(R3) guidance for industry.
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  • 21 August 2022
  • 296
Clinical Trials for Medicines: Apply for Authorization in the UK
On 18 July 2022 the MHRA updated the guidance on clinical trials for medicines.
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  • 21 August 2022
  • 306
Evaluation of Therapeutic Equivalence
On 21July 2022 the FDA published the draft guidance on evaluation of therapeutic equivalence of generic drugs. Submit comments by 19 September 2022.
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  • 21 August 2022
  • 302
Good Laboratory Practice (GLP) for Safety Tests on Chemicals
On 21 July 2022 the MHRA updated the guidance on GLP
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  • 21 August 2022
  • 315
ICH Guideline M12 on Drug Interaction Studies
On 21 July 2022 the EMA published the draft ICH guideline M12, step 2b.
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  • 21 August 2022
  • 407
Global Regulators Call for International Collaboration to Integrate Real-World Evidence into Regulatory Decision-Making
On 22 July 2022 the EMA announced the availably of a joint ICMRA statement on international collaboration to enable RWE for regulatory decision-making.
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  • 21 August 2022
  • 330
Real-Time Oncology Review (RTOR)
On 22 July 2022 the FDA published the draft guidance on real-time oncology review for industry. Submit comments by 20 September 2022.
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  • 21 August 2022
  • 340
Conducting Remote Regulatory Assessments Questions and Answers
On 22 July 2022 the FDA published the draft Q&A guidance on conducting remote regulatory assessments for industry.
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  • 21 August 2022
  • 319
Failure to Respond to an Abbreviated New Drug Applications (ANDA) Complete Response Letter (CRLs) within the Regulatory Timeframe
On 22 July 2022 the FDA published the final guidance on responding to complete response letters (CRLs) from FDA for industry.
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  • 21 August 2022
  • 349
Orange Book Questions and Answers Guidance for Industry
On 22 July 2022 the FDA published the final orange book Q&A guidance for industry.
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  • 21 August 2022
  • 300
Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices
On 22 July 2022 the FDA published the final UDI guidance for industry and FDA staff.
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  • 21 August 2022
  • 354
Clinical Trials Highlights - July 2022
On 25 July 2022 the EMA published the Clinical Trials Highlights, issue 10.
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  • 21 August 2022
  • 414
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis
On 27 July 2022 the EMA published the ICH guideline M10, step 5.
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  • 21 August 2022
  • 524
ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis – Frequently Asked Questions (FAQ)
On 27 July 2022 the EMA published the FAQ on ICH guideline M10, step 5.
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  • 21 August 2022
  • 346
General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products
On 27 July 2022 the FDA published the final guidance on general clinical pharmacology considerations for neonatal studies
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  • 21 August 2022
  • 259
Laser-Assisted in Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations
On 28 July 2022 the FDA published the draft guidance on patient labeling recommendations for LASIK lasers for industry and FDA staff. Submit comments by 26 October 2022.
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  • 21 August 2022
  • 445
Qualification Opinion of the Use of Enroll-HD (A Huntington’s Disease Patient Registry) as a Data Source and Infrastructure Support for Post-Authorization Monitoring of Medical Products
On 28 July 2022 the EMA published the qualification opinion on the use of Enroll-HD as a data source and infrastructure support for post-authorization monitoring of medical products.
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  • 21 August 2022
  • 333
Register Medical Devices to Place on the Market
On 28 July 2022 the MHRA updated the guidance on registration of medical devices.
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  • 21 August 2022
  • 450
PMDA Guidance on Risk Management Plan (RMP)
On 29 July 2022 the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) posted RMP page renewal, Q&A, templates, instructions and publication.
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  • 19 July 2022
  • 312
Questions & Answers - Practical Arrangements on the Companion Diagnostics Consultation Procedure to the European Medicines Agency by Notified Bodies
1 July 2022 — EMA published updated Q&A guidance on diagnostic consultation procedures.
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  • 19 July 2022
  • 966
Guidance on Applying the 2021 Advertising Code Rules
1 July 2022 — Australian Therapeutic Goods Administration (TGA) published the guidance on applying the advertising code rules for therapeutic goods.
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  • 19 July 2022
  • 336
Guideline on Advertising, etc. of Medicinal Products for Human Use
5 July 2022 — Danish Medicines Agency updated guideline on advertising of medicinal products for human use.
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  • 19 July 2022
  • 358
Identifying Trading Partners Under the Drug Supply Chain Security Act
5 July 2022 — FDA issued the draft guidance for industry. Submit comments by 05 September 2022.
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  • 19 July 2022
  • 357
OPEN Pilot: One-year Review and Recommendations
7 July 2022 — EMA published the OPEN Pilot report.
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  • 19 July 2022
  • 361
Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs)
12 July 2022 — Singapore Health Sciences Authority (HAS) announced the release of a draft regulatory guidelines for LDTs for stakeholders' consultation.
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  • 19 July 2022
  • 1002
Information about the Raw Data Proof-of-Concept Pilot for Industry
12 July 2022 — EMA announced the availability of access to raw data for marketing authorization and post-authorization applications submitted to the EMA.
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  • 19 July 2022
  • 347
GCP Inspection Site Report Template on Behalf of the EMA
12 July 2022 — EMA published the updated GCP inspection procedures for appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP.
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  • 19 July 2022
  • 403
Joint Controllership Arrangement: EudraVigilance Human (EV) Personal Data Capture
13 July 2022 — EMA published legal framework for the purpose of processing personal data captured in EudraVigilance Human (EV) administered by EMA
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  • 19 July 2022
  • 342
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological
14 July 2022 — FDA published the final guidance for industry.
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  • 19 July 2022
  • 445
Horizon Scanning Case Study: Point of Care Manufacture
15 July 2022 — UK MHRA published the horizon scanning case study.
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  • 19 July 2022
  • 340
The ICH Drug Interaction Studies M12 Draft Guideline Now Available Online
ICH announced the availability of the M12 draft guideline presentation.
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  • 19 July 2022
  • 373
Technology Capability Investment Plan
15 July 2022 — EMA published technology capability investment plan for becoming the digital hub for the European Medicines Regulatory Network.
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  • 19 July 2022
  • 372
European Medicines Agency’s Data Protection Notice for EudraVigilance Human (EV)
15 July 2022 — EMA published updated data protection notice for EudraVigilance Human.
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  • 11 July 2022
  • 374
Questions and Answers - Complex Clinical Trials
2 June 2022 — European Commission published updated Q&A guidance on complex clinical trials, version 2022-05-23.
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  • 11 July 2022
  • 382
Compliance Monitor (CM) Overview and Application Process
15 June 2022 — MHRA published updated guidance on the eligibility of the compliance monitor.
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  • 11 July 2022
  • 324
Marketing Authorization Application (MAA) Submission Dates for 150-days National and European Commission Decision Reliance Procedures
20 June 2022 — MHRA published updated guidance on MAA submission dates.
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  • 11 July 2022
  • 356
Guidance on Handling of Decentralized and Mutual Recognition Procedures Which are Approved or Pending
24 June 2022 — MHRA published updated guidance on the approach the MHRA intends to take for products approved or pending in decentralized procedure (DCP) or mutual recognition procedures (MRP).
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  • 11 July 2022
  • 457
European Medicines Agency Post-Authorization Procedural Advice for Users of the Centralized Procedure
20 June 2022 — EMA published updated Q&A guidance on extensions of marketing authorizations.
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  • 11 July 2022
  • 368
European Medicines Agency Pre-Authorization Procedural Advice for Users of the Centralized Procedure
20 June 2022 — EMA published updated pre-authorization Q&A guidance.
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  • 11 July 2022
  • 379
Updated IRIS Guide for Industry and Individual Applicants
28 June 2022 — EMA published the updated IRIS guide on how to create and submit scientific applications.
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  • 11 July 2022
  • 451
Workshop Report on Data Quality Framework for Medicines Regulation
29 June 2022 — EMA published workshop report on data quality framework for medicines regulation.
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  • 11 July 2022
  • 560
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB) User Manual
7 June 2022 — EMA published version 5.7 of the EVWEB user manual.
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  • 11 July 2022
  • 393
Article 57 User Interface (UI) Installation Guide
7 June 2022 — EMA published updated installation guide on article 57 UI components and initial set-up.
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  • 11 July 2022
  • 373
Orphans: Regulatory and Procedural Guidance and Forms
9 June 2022 — EMA announced updated procedural guidance documents on orphan designation.
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  • 11 July 2022
  • 369
Changing the Name or Address of a Sponsor
9 June 2022 — EMA announced update for submitting a request to change the name or address.
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  • 11 July 2022
  • 323
Mandatory Use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Using the EudraVigilance System
15 June 2022 — EMA announced EudraVigilance System online training course.
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  • 11 July 2022
  • 348
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
16 June 2022 — FDA published the final guidance for industry and FDA staff.
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  • 11 July 2022
  • 346
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures
21 June 2022 — FDA issued draft guidance for industry and FDA staff. Submit comments by 22 August 2022.
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  • 11 July 2022
  • 345
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
24 June 2022 — FDA published final guidance.
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  • 11 July 2022
  • 360
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
27 June 2022 — FDA issued draft guidance for comments by 25 September 2022.
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  • 11 July 2022
  • 410
Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment
27 June 2022 — FDA published final industry guidance on the treatment of renal cell carcinoma.
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  • 11 July 2022
  • 361
Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment
27 June 2022 — FDA published final industry guidance on the treatment of bladder cancer.
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  • 11 July 2022
  • 435
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
29 June 2022 — FDA issued draft guidance for comments by 28 September 2022.
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  • 11 July 2022
  • 345
Electromagnetic Compatibility (EMC) of Medical Devices
6 June 2022 — FDA issued guidance on EMC for industry and FDA staff.
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  • 11 July 2022
  • 393
Q9(R1) Quality Risk Management
14 June 2022 — FDA issued draft guidance for comments by 15 July 2022.
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  • 11 July 2022
  • 322
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
15 June 2022 — FDA issued draft guidance for comments by 14 September 2022.
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  • 02 June 2022
  • 421
IRIS Guide for Applicants
On 16 May 2022 the EMA published IRIS guide on how to create and submit scientific applications, for industry and individual applicants, version 2.10.
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  • 02 June 2022
  • 673
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
On 16 May 2022 the FDA published Final Level 2 revised guidance.
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  • 02 June 2022
  • 677
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors
On 18 May 2022 the FDA published the final guidance on safety considerations for labeling.
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  • 02 June 2022
  • 484
How to Notify the MHRA about a Clinical Investigation for a Medical Device
On 19 May 2022 the UK MHRA updated the guidance on notifying the MHRA of the intention to conduct a clinical investigation for medical devices.
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  • 02 June 2022
  • 438
Annual Report of the Good Clinical Practice Inspectors’ Working Group 2020
On 20 May 2022 the EMA published the annual report of the GCP IWG, which was adopted by the GCP IWG on 30 April 2022.
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  • 02 June 2022
  • 427
Risk Management Plans to Mitigate the Potential for Drug Shortages
On 20 May 2022 the FDA published the draft guidance on risk management plans for drug shortages. Comments may be submitted until 19 July 2022.
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  • 02 June 2022
  • 430
Medicines Shortages: Regulatory Processes to Manage Supply Disruptions
On 23 May 2022 the UK MHRA published the guidance on regulatory processes to manage supply disruptions.
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  • 02 June 2022
  • 532
Addendum to the Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections to Address Paediatric-specific Clinical Data Requirements
On 24 May 2022 the EMA published the addendum to the guideline on evaluation of medicinal products indicated for treatment of bacterial infections.
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  • 02 June 2022
  • 415
Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections
On 24 May 2022 the EMA published the revised guideline on the evaluation of human medicines for the treatment of bacterial infections, revision 3.
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  • 02 June 2022
  • 466
Clinical Trials Highlights – May 2022
On 25 May 2022 the EMA published Clinical Trials Highlights - Issue 9.
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  • 02 June 2022
  • 473
Supervise a Clinical Trial: Inspection Records – CTIS Training Programme – Module 16
On 25 May 2022 the EMA published FAQs on clinical trial inspection records.
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  • 02 June 2022
  • 471
Q&A on the Interface between Regulation (EU) 536/2014 on Clinical Trials for Medicinal Products for Human Use (CTR) and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices (IVDR)
On 25 May 2022 the European Commission published Q&A guidance on the interface between the EU CTR and IVDR.
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  • 02 June 2022
  • 400
Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1)
On 25 May 2022 the FDA published the draft Q&A guidance, revision 1. Comments may be submitted until 24 July 2022.
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  • 02 June 2022
  • 385
Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide
On 25 May 2022 the FDA published the final Q&A guidance for industry.
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  • 02 June 2022
  • 410
New Regulations Applicable to In Vitro Diagnostic Medical Devices
On 26 May 2022 the Swissmedic announced the entry into force of the new regulations on in vitro diagnostic medical devices.
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  • 02 June 2022
  • 394
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues
On 27 May 2022 the FDA published the final guidance for industry.
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  • 02 June 2022
  • 441
Questions and Answers Document – Regulation (EU) 536/2014
On 30 May 2022 the European Commission published Q&A guidance on the Clinical Trials Regulation, version 6.1.
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  • 02 June 2022
  • 471
Updated Frequently Asked Questions about Parallel Distribution
On 31 May 2022 the EMA published updated FAQs about parallel distribution.
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  • 16 May 2022
  • 458
Risklick Provides Clinical Trial Educational Programs
The Clinical Trial Academy Essential Program provided by Risklick is aimed to address the difficulties in developing an ideal clinical trial protocol.
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  • 16 May 2022
  • 543
Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development
On 2 May 2022 the FDA announced the availability of the draft guidance for industry.
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  • 16 May 2022
  • 427
ICH Guideline Q3D (R2) on Elemental Impurities
On 3 May 2022 the EMA published step 5 of the revised ICH guideline Q3D (R2) on elemental impurities.
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  • 16 May 2022
  • 407
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 4 May 2022 the FDA published the final guidance for industry and FDA staff.
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  • 16 May 2022
  • 446
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies
On 5 May 2022 the FDA published the draft guidance for industry. Comments may be submitted until 4 August 2022.
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  • 16 May 2022
  • 530
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
On 5 May 2022 the FDA published the draft guidance for industry and FDA staff. Comments may be submitted until 5 July 2022.
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