Significant advancements in global harmonization efforts at ICH’s largest biannual meeting to-date
Sixteen Members and twenty-eight Observers met in Amsterdam
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China makes switch to faster approval system for imported drugs
NMPA and National Health Commission of China have established faster system to review and approve on urgently needed new drugs that have been approved in other countries
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EMA eSource Direct Data Capture (DDC) qualification opinion issued
the regulatory acceptability to use an eSource Direct Data Capture in Clinical Trials
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EMA use of patient disease registries for regulatory purposes
Methodological and operational considerations by a cross-committee task force on Registries
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FDA Facilitates the Use of Surrogate Endpoint in Drug Development
CDER small business and industry assistance podcast news from November 2018
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EMA Draft questions and answers on Data Monitoring Committees issues
A Supplement to the CHMP Data Monitoring Committee Guideline
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EMA on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
New Draft Guideline issued; consultation end date: July 2019
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FDA Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases
New FDA Guidance for Industry
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New FDA Draft Guidance on Hematologic Malignancy and Oncologic Disease
Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development
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New FDA draft Guidance on Expansion Cohorts
Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
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CNDA seeks feedback on latest GCP Regulation Draft
The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018
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FDA Announces Two Initiatives on Quality Metrics Program Development
FDA is looking for feedback on their recent Quality Initiatives on Metrics
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FDA Publishes List of Surrogate Endpoints Used in Drug Approvals
The list includes surrogate endpoints for approval of new drug applications
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EMA Policy 70 submissions temporarily suspended as of 1 August
Phase 2 of EMA’s Business Continuity Plan soon to come into effect
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Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance
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Re-issuing of USFDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA (Biosimilar User Fee Act) Products
Comments are encouraged within 90 days of issuance
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New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Draft Guidance published for receiving comments within 60 days
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Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
Agreement now operational between 14 EU Member States and FDA
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Informed Consent for Pediatric Clinical Trials in Europe 2015 - Updated
Update from May 2018 detailing procedures in all member states
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Pediatric investigation plans: questions and answers
Detailed guidance for sponsors applying for a pediatric investigation plan (PIP)
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EMA draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice
EMA asks for comments on the new guideline by end of August 2018
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USFDA issue new Guidance on Clinical Trial Imaging Endpoint Process Standards
Final Guidance for Industry effective April 2018
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US FDA issues Institutional Review Board (IRB) Written Procedures
Final Guidance for Institutions and IRBs effective May 2018
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New EMA Draft Guideline on Clinical Evaluation of Vaccines
Comments can be sent in until 30th October 2018
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Increasing oversight of API manufacturing through international collaboration
Report on the International API inspection program published
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USFDA’s Revision 1 of the Special Protocol Assessment Guidance
In Effect: April 2018 – May 2020
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New USFDA draft Guidance on in-vitro Diagnostics in Oncology Trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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USFDA issue new draft Guidance on inclusion of pregnant women in clinical trials
Comments and suggestions regarding this draft document should be submitted within 60 days of publication
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Beat Widler to moderate session at EFGCP Workshop 18th June 2018, London
Investigators meet Inspectors workshop by EFGCP in the light of ICH E6R2
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New tracking tool for EMA’s relocation to Amsterdam
Tool gives transparent overview of main milestones and work stream deliverables
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USFDA’s Compliance Policy for Combination Product Post-Marketing Safety Reporting
Immediately in Effect Guidance for Industry and Food and Drug Administration Staff
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China’s NHFPC and CFDA to be downgraded amid ministerial reshuffle
The National People’s Congress officially approved plans for a ministry shakeup
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CHMP adopts new Guideline on Good Pharmacogenomic Practice
The new guideline adopted by the CHMP will become effective on 1st September 2018
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Clinical site initiation process remains lengthy and highly inefficient
New Tufts Center Report
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China’s CDE clarifies NDA dossier requirements
A wave of PD-1/PD-L1 mAb application pushes CDE to act
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USFDA releases ICH Q11 guidance Q&A document
ICH Q11 Q&A document specifically about starting materials
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USFDA releases ICH E6 R2 guidance
ICH guideline issued by the USFDA
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USFDA BIMO Report presentation issued
The presentation gives an overview on the 2017 inspections and findings
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General Court confirms EMA approach to transparency
Three rulings clarify the scope of commercial confidentiality with regard to authorized medicines
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CFDA’s “Orange Book” launch marks new era of quality generics
Standards for generic products will ensure quality throughout the Chinese market
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CFDA moving to implement greater transparency over drug reviews
As full ICH member CFDA applies international standards
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CFDA applying ICH technical guidelines to drug filings, safety management
CFDA’s follow up on full ICH membership
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EMA surveys pharma companies on their preparedness for Brexit
Planning of regulatory steps needed to ensure medicines remain on EU market
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Update: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Guidance for Industry and Food and Drug Administration Staff
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Small Business and Industry Assistance (SBIA) Documents in Chinese
US FDA provides SBIA documents in Chinese Translation
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US FDA Draft Guidance: The Least Burdensome Provisions - Concept and Principles
Draft Guidance for Industry and Food and Drug Administration Staff
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New US FDA Draft Guidance
Refuse to File: NDA and BLA Submissions to CDER
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Regulatory guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
EMA and European Commission publish updated Q&As
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EMA adopts ICH guideline E17
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials coming into effect in June 2018
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Henk de Wilde joins Widler & Schiemann Ltd. as Managing Director
Henk de Wilde will join Widler & Schiemann Ltd. in Switzerland in January 2018
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USFDA Widens Scope of Navigator – Information Tool for Expanded Access
Two examples of the recent steps US FDA has taken in pursuit of improving their expanded access and orphan drug program
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New Edition of the International Compilation of Human Research Standards
2018 Edition now available
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New EudraVigilance system is live
Better safety monitoring for patients across Europe
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EU-US mutual recognition of inspections of medicines manufacturers enters operational phase
Major milestone is a testimony to mutual trust
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Xi Chen joins Widler & Schiemann Ltd. China as Managing Director
Ms. Xi Chen, MSc, MBA, has joined WS China with more than 20 years of industry experience
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China will allow private hospitals and other health related institutions
In his speech at the 19th National Congress of the CPC, President Xi Jinping emphasized the focus on “Healthy China”
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China now accepting Clinical Trial Data from other Countries
CFDA issued a new guideline announcing that for submissions clinical trial data from other countries will be accepted
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Updates on EMA Guideline on Good Pharmacovigilance Practice
Two of the updated Modules will become effective in November 2017
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New USFDA Draft Guidance on ANDA and 505(b)(2) Application
USFDA provides a guide for decision making whether to submit an ANDA or 505(b)(2)
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Update on USFDA Draft Guidance on REMS
Update on format and content of a REMS document – Revision of the 2009 Guidance
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Widler & Schiemann open China Office
Business license obtained, first employee hired
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New Pharmacovigilance (PV) Inspection Guide by Australian Health Authority
The Therapeutics Goods Administration (TGA) issued a new guidance for medicine sponsors on PV
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China FDA to issue catalogue of all drugs marketed in China
A Chinese Version of the USFDA’s “Orange Book” will be available soon
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Patient safety: Commission adopts acts on Good Manufacturing Practices for medicines
Focus on Marketed Products and Investigational Medicinal Products
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USFDA is advancing the Goals of the Orphan Drug Act
An Update from the USFDA Commissioner on the achievements to date
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Final USFDA Guidance on Real World Evidence and Medical Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
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New USFDA Draft Guidance on submitting REMS in SPL Format
Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling Guidance for Industry
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The new 2017 Good Clinical Practice Q&A Guide is available!
Dr. Beat Widler is a reappearing author for this guide and member of the editorial board
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EMA Guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: pediatric population
New Guideline open for comments until 13th October 2017
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EMA prepares for Brexit
Business continuity plan aims to preserve Agency’s ability to protect public and animal health
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SUMMARY OF THE RESPONSES TO THE PUBLIC CONSULTATION
RISK PROPORTIONATE APPROACHES IN CLINICAL TRIALS
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Dr. Oliver Hellstern invited as lecturer for Pharmacovigilance at ETH Zurich
Our PV Practice Leader, Dr. Oliver Hellstern, to teach about Pharmacovigilance at the University ETH Zurich
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Strengthening EU-US cooperation in medicine inspections
New commitment allows FDA to share full inspection reports with European Commission and EMA
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New ICH E19 Guideline in development on Optimisation of Safety Data Collection
Guidance on targeted approach to safety data collection
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EMA: Revised Guideline for Entry into Human
Guidance outlines strategies to identify and mitigate risks for trial participants
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USFDA aims to foster generic drugs
A recent email announcement by USFDA lists the details
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Update of the BIMO Guidance Manual
USFDA announced that a major revision BIMO manual was issued in April 2017 – Guidance for FDA staff
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New USFDA Draft Guideline on Electronic Records and Signatures
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers
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FDA Updates Part 11 Guidance for Clinical Trials to Include Mobile and Wearable Tech
Public Comments are invited until late August 2017
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Brookwood Academy launches “PV Training for All” Module
EFGCP GCP Discussion Group reviewed the first module
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New action plan to support SMEs as drivers of pharmaceutical innovation
16 actions identified for implementation in 2017-2020
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EMA and EUnetHTA step up interaction to align data requirements
A new joint platform for parallel consultation will provide advice to medicine developers and facilitate access to medicines for patients
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UK’s withdrawal from the EU
EMA publishes first thoughts on implications and mitigating actions.
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China announced official ICH member
At the ICH Meeting in Montreal, China’s ICH membership was confirmed
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Canada sets date for implementation of ICH E6 R2
The date shall be the 1st April 2018
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East African Community looks to EMA as model for future regional agency
EMA and East African regulators met on 18-19 May 2017
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Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017
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No timeline at FDA for adoption of ICH E6 (R2)
Widler & Schiemann asked the USFDA as no information can be found on their homepage
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EMA issues Draft Guideline on Serious Breaches
Breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
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China submits conditional application to join ICH
At DIA China Annual Meeting China Secretary Yuan Lin confirmed China’s application
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Widler & Schiemann Ltd. and Beijing Jingwei Chuanqi Medicines Service Ltd. start Joint Venture in China
WS China will be a joint venture together with our partner 3Audit
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CFDA prunes medical device standards management guidelines
CFDA amends Medical Device Guideline
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Second Annual Workshop on Clinical Outcome Assessments in Cancer Clinical Trials
FDA’s CDER and C-Path’s PRO consortium second workshop
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Summary of changes to the guidance of publication of clinical trial data by EMA
Update to the guidance published on March 03, 2016
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The EFPIA Disclosure Experience: An Update
EFPIA offers an update on media and industry responses
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EMA publishes new draft GCP guideline on TMF requirements
The deadline for comments is 11 July 2017
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Small and Mid size Biotech Companies’ EDMS
Pocket EDMS URS include now TMF requirements
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EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs Release: 15.04.2017 02:03:36
Medicines where suitable alternative data are available can remain on market
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