EMA EudraVigilance Registration Manual
On 13 November 2019 the EMA published the updated EudraVigilance registration manual
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New Organization First User QPPV/RP or Change of EU QPPV/RP
On 13 November 2019 the EMA published the updated First User or Change of EU QPPV/RP for new organization
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EMA Regulatory Science to 2025 - Five goals
On 14 November 2019 the EMA updated its five goals for human medicine regulation
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Guideline on clinical investigation of medicinal products for the treatment of gout
On 14 November 2019 EMA updated the guidance to provide the evaluation of drugs for the treatment of gout. This guide will come into effect on 1 June 2020.
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Smallpox (Variola Virus) Infection: Developing
Drugs for Treatment or Prevention Guidance for Industry
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EMA updated Inspections procedure
On 7 October 2019, the 1,000th good clinical practice (GCP) inspection requested by EMA’s human medicines committee (CHMP) and coordinated by EMA was carried out.
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Providing Regulatory Submissions in Electronic Format: IND Safety Reports
On October 29, 2019 FDA published this draft guidance for comment by December 30, 2019. This guidance only applies to IND safety reports for serious and unexpected suspected adverse reactions required under 21 CFR 312.32(c)(1)(i).
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Electronic Submission of IND Safety Reports Technical Conformance Guide
This Document supplements the following Guidance Document: Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019).
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Biosimilars in the EU - Information guide for healthcare professionals
On October 29, 2019 EMA and EC updated the guide on biosimilars in the EU. This guide was first published in May 2017.
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Dialogue with Chinese authorities on medicine regulation
On October 25, 2019 the Chinese National Medical Product Administration (NMPA) delegation visited EMA. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals.
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Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
On October 24, 2019 FDA posted this draft guidance for industry. Comments may be submitted by December 24, 2019
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Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)
On 21 October 2019, EMA updated the questions and answers. This update focuses on aspects relating to the implementation and applicability of the requirements of Regulation (EU) 2017/745 to medicinal products with an integral or co-packaged medical device.
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Drug Master Files (DMFs) Guidance for Industry
On 18 October 2019 FDA announced the availability of this draft guidance. Once finalized, this guidance will provide FDA's current thinking on DMFs. Comments may be submitted by December 12, 2019.
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Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products (ATMPs)
On 10 October 2019 European Commission issued the guidelines on GCP specific to clinical trials conducted with ATMPs
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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
MHRA updated this guidance on October 11, 2019. Pharmacovigilance system requirements if there is a no-deal Brexit.
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Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry
On October 9, 2019 FDA announced the availability of the final guidance for industry. This guidance describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.
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PRIME (priority medicines) Eligibility Requests
On October 4, 2019 EMA announced deadlines for submission and timetable for assessment in 2020
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EU Clinical Trial Regulation Update
On October 4, 2019 EMA updated the Clinical Trial Regulation (No 536/2014) in the EU
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Investigational Enzyme Replacement Therapy (ERT) Products: Nonclinical Assessment
On October 1, 2019 FDA published this guidance for comment purposes only. Submit comments by January 2, 2020.
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FDA’s Top GMP Inspection Findings for Fiscal Year 2019
Drugmakers continue to stumble at the same old hurdles: failure to document quality unit responsibilities and procedures
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Clinical Decision Support Software
FDA issued a draft guidance document on Clinical Decision Support Software on September 27, 2019 and opened for public comment until December 26, 2019.
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NMPA officially joins Medical Device Regulators Forum (IMDRF) National Competent Authorities Report (NCAR) Exchange Program
On September 19, 2019 the IMDRF approved the Chinese National Medical Products Administration (NMPA) to join the IMDRF National Competent Authorities Report (NCAR) Exchange Program.
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Safer Technologies Program for Medical Devices
FDA issued a draft document of Safer Technologies Program for Medical Devices on September 19, 2019 and opened for public comment until November 18, 2019.
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EMA EudraVigilance Registration Manual
On September 25, 2019 EMA issued EMA EurdaVigilance Registration Manual.
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New Organization First User QPPV/RP or Change of EU QPPV/RP
On September 25, 2019 EMA informed that sponsors need to notify EMA in case of new organization first user QPPV/RP or change of EU QPPV/RP.
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Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorization holders (MAHs)
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) in a no-deal Brexit.
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Policy for Device Software Functions and Mobile Medical Applications
On September 27, 2019 the FDA issued this guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile or on other general-purpose computing platforms.
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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
FDA issued a final guidance on Medical Device Data Systems for industry and FDA staff on September 27, 2019. The policy described in this guidance document is also consistent with the Agency’s updated guidance entitled “Policy for Device Software Functions and Mobile Medical Applications,” originally issued on February 9, 2015, with the title “Mobile Medical Applications.”
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Post-marketing Safety Reporting for Combination Products
FDA issued the final guidance for industry and FDA staff on July 22, 2019
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Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry
The US FDA issued the final guidance on the use of placebos and blinding in randomized controlled cancer clinical trials on August 27, 2019
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The National People's Congress of China issued the 2nd Revision of Drug Administration Law
The new revised Drug Administration Law of China will be effective since December 01, 2019
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EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorization decisions for new medicines
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Questions Pile up for Novartis as Senators Call on FDA to Take Action
The importance of having a robust investigation process in place supported by a clear SOP and structured guidance documents on how to conduct an investigation
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Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal
U.K. MHRA Updates Information Pages in the Event of a No-Deal Brexit on August 6, 2019
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What’s new in Pharmacovigilance? QPPV Update
EMA published the QPPV Update on August 1, 2019
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Guideline on Clinical Investigation of Medicinal Products for the Treatment of Gout (Draft)
EMA updated this Draft with the end of consultation on August 31, 2019
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ICH Global Meeting on ICH E8(R1) Guideline on General Considerations for Clinical Trials
ICH is announcing a public meeting on E8(R1), to be held on October 31, 2019 at 08:30 a.m. to 5:00 p.m. ET in Silver Spring, Maryland, USA, with Webcast option available.
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General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry
Comments and suggestions regarding this draft document should be submitted by October 30, 2019
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Why Industry Anticipates a ‘Cliff-Edge’ Scenario with EU MDR/IVDR
Manufacturers and the European Association of Notified Bodies alike face difficult decisions with the new
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Regulations on Customized Medical Device Supervision and Management (Trial Version) in China
New regulations on customized medical devices in China
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German Study Finds Most New Drugs Fail to Improve on Standard of Care
Germany’s Institute of Quality and Efficiency in Healthcare (IQWiG) finds there is no evidence of added benefit for more than half of the drugs the institute assessed from 2011-2017.
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Risk Evaluation and Mitigation Strategies:
Modifications and Revisions Guidance for Industry
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Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent
Pregnancy Guidance for Industry
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One additional country to benefit from EU-US mutual recognition agreement for inspections
Germany Joins EU-US GMP Mutual Recognition Pact
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Optimisation of Safety Data Collection
This guidance is being distributed for comment purposes only
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ANDA Submissions — Content and Format of Abbreviated New Drug Applications
Guidance for Industry ensuring a complete, high-quality application submitted to FDA
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Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
This guidance document is being distributed for comment purposes only.
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Research Investigational New Drug Applications – What You Need To Know
Similarities and differences in submission requirements for Commercial and Research IND
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China publishes regulation on management of human genetic resources
New rules to regulate genetic research
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Guidance Document: Pre-market Requirements for Medical Device Cybersecurity
Health Canada’s new premarket requirements on medical device cybersecurity came into effect
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China to stipulate the accountabilities of Marketing Authorization Holder (MAH)
China released the “Revision of the Drug Administration Law of the People's Republic of China” for public comment
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China to implement new regulation for on-site inspections at the clinical sites and manufacturing facilities
National Medical Products Administration (NMPA) released “Regulations for on-site inspections at the clinical sites and manufacturing facilities” for public comment
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EMA Guideline on the quality requirements for drug-device combinations
Documentation expected for Drug-Device Combinations (DDCs)
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FDA Report on Pharmaceutical Quality
Product Quality of Products marketed in the USA
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RWD & RWE in FDA submissions
New Draft Guideline on Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics
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ICH E8 under revision
The ICH Guideline “General Considerations for Clinical Trials” is under revision and has been issued for public comments
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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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