EMA Procedural Advice for Users of the Centralized Procedure
On 13 January 2021 the EMA updated 3 guidance on pre-/post-authorization procedural advice for users of the centralized procedure or for generic/hybrid applications.
Read more online
Read
EMA Updated Guidance on Obtaining and Maintaining a Scientific Opinion on a Medicine for Use Outside the EU
On 14 January 2021 the EMA updated the guidance on promoting parallel application for EU-M4all opinion and centralized marketing authorization procedure.
Read the pdf
Read
EMA Updated Questions & Answers on Signal Management
On 15 January 2021 the EMA published revision 4 of the Q&A on signal management.
Read the pdf
Read
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
On 15 January 2021 the FDA published the final guidance for industry.
Read more online
Read
EMA Updated Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers
On 16 December 2020 the EMA updated Q&A guidance on GMP and GDP in EU GMP guide part I, chapter 5.
Read more online
Read
EMA Updated Questions and Answers on Labeling Flexibilities for COVID-19 Vaccines
On 16 December 2020 the EMA published the revision 1 of Q&A document on labelling flexibilities for COVID-19 vaccines.
Read the pdf
Read
Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
On 16 December 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
ontrolled Correspondence Related to Generic Drug Development Guidance for Industry
On 16 December 2020 the FDA published the final guidance for industry.
Read more online
Read
Dry Eye: Developing Drugs for Treatment
On 16 December 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 17 March 2021.
Read more online
Read
EMA Updated IRIS Guide for Applicants
On 17 December 2020 the EMA published the updated version 1.9 of IRIS guide for industry and individual applicants.
Read the pdf
Read
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
On 17 December 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
EMA Updated Clinical Trials Information System Development
On 18 December 2020 the EMA published the updated clinical trials information system (CTIS) development.
Read more online
Read
Procedural Advice for Post-orphan Medicinal Product Designation Activities
On 21 December 2020 the EMA published the guidance for sponsors.
Read the pdf
Read
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency — Guidance for Industry
On 21 December 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers (Revised)
On 22 December 2020 the FDA published the updated Q&A guidance for industry and FDA staff.
Read more online
Read
Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
On 23 December 2020 the FDA published the final guidance for industry.
Read more online
Read
MHRA Guidance on Submitting Clinical Trial Safety Reports
On 31 December 2020 the MHRA published the guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).
Read more online
Read
Exceptions and Modifications to the EU Guidance on Good Pharmacovigilance Practices that Apply to UK Marketing Authorization Holders and the Licensing Authority
On 31 December 2020 the MHRA published a guidance note on GVP.
Read the pdf
Read
MHRA Guidance on Substantial Amendments to a Clinical Trial
On 31 December 2020 the MHRA published guidance on substantial amendments to a clinical trial.
Read more online
Read
Requesting FDA Feedback on Combination Products
On 3 December 2020 the FDA Announced the Availability of the Final Guidance for Industry and FDA Staff.
Read more online
Read
Update to FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency
On 4 December 2020 the FDA Updated the Final Guidance for Industry, Investigators, and Institutional Review Boards.
Read more online
Read
Reflection Paper on Patient-Focused Drug Development for Public Consultation
On 7 December 2020 the ICH Published the Reflection Paper on PFDD for Public Consultation by 7 March 2021.
Read the pdf
Read
MHRA Updated Guidance on Regulating Medical Devices from 1 January 2021
On 7 December 2020 the MHRA Updated the Medical Devices Guidance.
Read more online
Read
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry
On 8 December 2020 the FDA Announced the Availability of the Draft Guidance for Industry.
Read more online
Read
European Medicines Agencies Network Strategy to 2025
On 8 December 2020 the EMA Published the Joint Strategy Setting Direction for EMA and EU Medicines Regulatory Agencies to 2025.
Read the pdf
Read
The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process
On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.
Read more online
Read
Clinical Trials Information System (CTIS) Highlights – December 2020
On 9 December 2020 the EMA Published Issue 2 of CTIS Highlights.
Read the pdf
Read
Best Practices in Developing Proprietary Names for Human Prescription Drug Products
On 9 December 2020 the FDA Announced the Availability of the Final Guidance for Industry.
Read more online
Read
Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway
On 11 December 2020 the FDA Issued the Final Guidance for Industry and FDA Staff.
Read more online
Read
Questions and Answers to Stakeholders on the Implementation of the Protocol on Ireland / Northern Ireland
On 11 December 2020 the EMA Published Revision 2 of the Q&A Document.
Read the pdf
Read
Remote Pharmacovigilance Inspections of MAHs during a Crisis Situation - Points to Consider
On 18 November 2020 the EMA announced the availability of revision 1 of the guidance adopted by Pharmacovigilance Inspectors Working Group.
Read the pdf
Read
Clinical Drug Interaction Studies with Combined Oral Contraceptives
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 22 February 2021.
Read more online
Read
Cross Labeling Oncology Drugs in Combination Regimens
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
Read more online
Read
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act
On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.
Read more online
Read
Qualification Process for Drug Development Tools
On 24 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online
Read
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
On 24 November 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
On-site Access to Electronic Health Records by Sponsor Representatives in Clinical Trials
On 26 November 2020 the UK MHRA published the new guidance for Sponsors, CROs and investigator sites.
Read more online
Read
Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry
On 30 November 2020 the FDA published the draft guidance for industry. Submit comments by 26 February 2021.
Read more online
Read
MHRA Updated Guidance on Pharmacovigilance Procedures
On 30 November 2020 the MHRA updated the guidance on pharmacovigilance procedures.
Read more online
Read
EMA Updated Q&A: Good Clinical Practice (GCP)
On 3 November 2020 the EMA added a new Q&A (#14) to the GCP matters section.
Read more online
Read
Joint Guidance of Swissmedic and Swissethics on the Management of Clinical Trials with Medicinal Drug Products in Switzerland during the COVID-19 Pandemic
On 4 November 2020 Swissmedic and swissethics issued version 2.3 of their joint guidance.
Read more online
Read
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices
On 6 November 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online
Read
Drug Trial Snapshots Summary Report – from 2015 to 2019
On 9 November 2020 the FDA announced the availability of a five-year summary and analysis of clinical trials participation and demographics.
Read more online
Read
Regulatory Considerations for Microneedling Products
On 9 November 2020 the FDA issued the final guidance for industry and FDA staff.
Read more online
Read
Detailed Guide Regarding the EudraVigilance Data Management Activities by the EMA
On 9 November 2020 the EMA announced the availability of the updated guide.
Read the pdf
Read
Guidance on Minimizing Disruptions to the Conduct and Integrity of Clinical Trials of Medicines During COVID-19
On 11 November 2020 the UK MHRA issued the guidance.
Read more online
Read
Information on the Member States Requirement for the Nomination of a Pharmacovigilance (PhV) Contact Person at National Level
On 11 November 2020 the EMA PhV Inspectors Working Group (IWG) updated the information on PhV contact person.
Read the pdf
Read
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs
On 13 November 2020 the FDA issued the final guidance for industry.
Read more online
Read
Certificates of Confidentiality
On 13 November 2020 the FDA issued the final guidance for sponsors, sponsor-investigators, researchers, industry, and FDA staff.
Read more online
Read
Consideration on Core Requirements for Risk Management Plans of COVID-19 Vaccines —CoreRMP19 Guidance
On 13 November 2020 the EMA issued the new guidance on risk management plans (RMPs) for COVID-19 vaccines.
Read the pdf
Read
Technical Requirements for Clinical Development of Overseas-marketed and Domestic-non-marketed Products
On 12 October 2020 the Chinese CDE of NMPA issued notification No. 29 on technical requirements.
Read more online
Read
EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance
On 19 October 2020 the EMA issued guidance revision 10 addressing a number of questions that users of the scientific advice or protocol assistance procedures may have.
Read the pdf
Read
Reflection Paper on the Pharmaceutical Development of Medicines for Use in the Older Population
On 22 October 2020 the EMA issued this reflection paper for medicine developers.
Read the pdf
Read
Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF) from 1 January 2021
On 23 October 2020 the MHRA updated guidance on the QPPV and PSMF for UK authorized products.
Read more online
Read
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989 Guidance for Industry
On 20 October 2020 the FDA announced the availability of the draft guidance for industry.
Read more online
Read
Updated Guidance on Pharmacovigilance (PV) Procedures
On 27 October 2020 the MHRA published the updated guidance on PV procedures.
Read more online
Read
Referencing Approved Drug Products in ANDA Submissions
On 27 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
Providing Regulatory Submissions in Electronic Format — Standardized Study Data
On 29 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment
On 1 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
EMA Updated the Status of Clinical Trials Information System (CTIS)
On 5 October 2020 the EMA announced that the audit of the clinical trial information system (CTIS) will commence in November 2020.
Read more online
Read
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment
On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.
Read more online
Read
MHRA Guidance on the Licensing of Biosimilar Products
On 7 October 2020 the MHRA published the open consultation document.
Read more online
Read
Checklist for Annual Updates for Parallel Distribution
On 8 October 2020 the EMA announced the availability of the guidance for industry.
Read the pdf
Read
Questions and Answers on Data Monitoring Committees Issues
On 8 October 2020 the EMA published the Q&A document on DMC issues.
Read the pdf
Read
Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin
On 15 October 2020 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted until 15 December 2020.
Read more online
Read
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
On 15 October 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online
Read
Testing for Biotin Interference in In Vitro Diagnostic Devices
On 15 October 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
Updated IRIS Guide for Applicants
On 15 October 2020 the EMA updated the IRIS guide on how to create and submit scientific applications for industry and individual applicants.
Read the pdf
Read
WSQMS Managing Partner Dr. Beat Widler Key Speaker at 20-year Anniversary of Swiss Centers China in Neuchatel
On 16 October 2020 the Swiss Centers China celebrated its 20-year anniversary in Neuchatel Switzerland.
Read more online
Read
Estelle Chao Promoted to Managing Director APAC at Widler & Schiemann Ltd. Shanghai
On 19 October 2020 WSQMS Managing Partner Dr. Peter Schiemann announced the promotion of Estelle Chao to Managing Director APAC with immediate effect.
Read more online
Read
Export Certificates and Manufacturing Certificates for Medical Devices
On 30 July 2020 the Swissmedic published the information sheet about issuing export and manufacturing certificates for medical devices.
Read more online
Read
Authorizations for Non-conforming Medical Devices
On 1 August 2020 the Swissmedic published the information sheet about the authorizations for non-conforming medical devices.
Read more online
Read
Eosinophilic Esophagitis: Developing Drugs for Treatment
On 15 September 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
Geriatric Information in Human Prescription Drug and Biological Product Labeling Guidance for Industry
On 15 September 2020 the FDA announced the availability of the draft guidance for industry. Comments may submit by 16 November 2020.
Read more online
Read
Inclusion/Exclusion Criteria for the “Important Medical Events” List
On 18 September 2020 the EMA published the inclusion/exclusion criteria for the “Important Medical Events” list.
Read the pdf
Read
European Medicines Regulatory Network (EMRN) COVID-19 Business Continuity Plan
On 18 September 2020 the EMA announced the availability of the updated EMRN COVID-19 business continuity plan.
Read the pdf
Read
Guideline on Registry-based Studies
On 24 September 2020 the EMA issued the draft guideline on registry-based studies.
Read the pdf
Read
The ICH Q3D(R2) Draft Guideline Available Now on the ICH Website
On 25 September 2020 the ICH Q3D(R2) draft guideline on elemental impurities reached step 2 of the ICH process.
Read the pdf
Read
Updated FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency
On 28 September 2020 the FDA updated the final guidance for industry, investigators, and institutional review boards.
Read more online
Read
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs
On 28 September 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe
On 28 September 2020 the FDA announced the availability of the draft guidance for industry.
Read more online
Read
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
On 29 September 2020 the FDA announced the availability of the draft guidance for industry. Comments can be submitted until 30 November 2020.
Read more online
Read
MHRA Post-Transition Period Information
On 1 September 2020 the UK MHRA published guidance for industry and organizations to follow from 1 January 2021.
Read more online
Read
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling
On 3 September 2020 the FDA announced the availability of the draft final guidance for industry.
Read more online
Read
Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"
On 4 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online
Read
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency
On 10 September 2020 the FDA announced the availability of the guidance for industry.
Read more online
Read
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment
On 14 September 2020 the FDA announced the availability of the guidance for industry.
Read more online
Read
Recognition and Withdrawal of Voluntary Consensus Standards
On 14 September 2020 the FDA announced the availability of the final guidance for industry and FDA staff.
Read more online
Read
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment
On 17 August 2020 the FDA announced the availability of the draft guidance for industry.
Read more online
Read
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
On 18 August 2020 the FDA announced the availability of the guidance for industry.
Read more online
Read
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
On 19 August 2020 the FDA announced the availability of the guidance for industry.
Read more online
Read
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases
On 25 August 2020 the FDA announced the availability of the draft guidance for industry.
Read more online
Read
Quick Interactive Guide to IRIS Registration Process
On 25 August 2020 the EMA announced the availability of the quick interactive guidance.
Read the pdf
Read
Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Questions and Answers
On 27 August 2020 the ICH E14/S7B Implementation Working Group (IWG) announced the availability of the ICH E14/S7B Draft Q&As.
Read the pdf
Read
Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation
On 28 August 2020 the FDA announced the availability of the draft guidance for industry and FDA staff, and other stakeholders.
Read more online
Read
MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19)
On 4 August 2020 the UK MHRA updated the guidance for industry on flexible approaches to regulations taken during the COVID-19 outbreak.
Read more online
Read
Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format
On 10 August 2020 the FDA announced the availability of the final guidance for industry.
Read more online
Read
EMA Updated Post-Authorisation Safety Studies (PASS)
On 10 August 2020 the EMA updated post-authorisation safety studies.
Read more online
Read
MHRA’s Expectations for Return to UK On-site Inspections
On 11 August 2020 the MHRA published the guidance for industry on planning to resume on-site UK risk-based GxP inspections in September.
Read more online
Read
Drug-Drug Interaction Assessment for Therapeutic Proteins
On 12 August 2020 the FDA announced the availability of the draft guidance for industry.
Read more online
Read