Overview of Comments Received on ICH Guideline E8 (R1) on General Considerations for Clinical Studies
On 7 April 2020 the EMA published an overview of comments received from 40 stakeholders on ICH guideline E8(R1).
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Bioresearch Monitoring (BIMO) Fiscal Year 2019 Metrics
On 8 April 2020 the FDA published the bioresearch monitoring inspection metrics for the fiscal year 2019.
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Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak
On 9 April 2020 the UK MHRA published the guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home.
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Guidance on regulatory requirements in the context of the COVID-19 pandemic
On 10 April the European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on
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Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
On 13 April 2020 the FDA announced the availability of this final guidance for industry.
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Pharmacovigilance Inspection Metrics Report (April 2018 – March 2019)
On 15 April 2020 the UK MHRA published the annual report of pharmacovigilance inspection metrics from April 2018 till March 2019.
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Medical Devices Clinical Investigations during the Coronavirus (COVID-19) outbreak
On 30 March 2020 the MHRA published the updated this guidance for investigators and sponsors of ongoing clinical investigations and new applications.
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EMA EudraVigilance Registration Manual
On 26 March 2020 the EMA updated the EudraVigilance XCOMP (Test system) registration process.
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Global Regulators Map out Data Requirements for Phase 1 COVID-19 Vaccine Trials
On 24 March 2020 the EMA announced that global regulators have published a report presenting the outcomes of a workshop on COVID-19 vaccine development.
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EMA Management Board – highlights of March 2020 meeting
On 20 March 2020 the EMA highlighted the update on the development of the Clinical Trials Information System (CTIS) for the EU Clinical Trials Regulation.
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EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
On 20 March 2020 the EMA issued this guidance for industry, investigators and IRBs and on 27 March updated it.
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Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic
On 20 March 2020 the FDA announced the availability of this final guidance for industry.
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FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
On 18 March 2020 the FDA issued this final guidance for industry, investigators and IRBs and on 27 March updated it.
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Guidance on Paediatric Submissions
On 18 March 2020 the EMA issued the new guidance on eSubmission Gateway and eSubmission web client for paediatric investigation.
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Competitive Generic Therapies
On 13 March 2020 the FDA announced the availability of the final guidance for industry.
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510(k) Third Party Review Program
On 12 March 2020 the FDA issued the guidance for industry, FDA staff and third party review organizations.
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Providing Regulatory Submissions in Alternate Electronic Format
On 10 March 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 11 May 2020.
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GCP Inspections: Expectations and the dos and don’ts for hosting
On 10 March 2020 the MHRA posted the expectations of GCP inspections in the blog of the MHRA inspectorate.
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Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections
On 10 March 2020 the FDA announced that the agency halts routine inspections overseas through April due to coronavirus.
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China awards Gilead’s remdesivir patents, scolds local pharma over newsjacking
On 10 March 2020 GBI discussed China’s IP landscape and issues surrounding patent standards.
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Safety Testing of Drug Metabolites
On 5 March 2020 the FDA announced the availability of the final guidance for industry.
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ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
On 4 March 2020 the EMA published the Step 5 for ICH guideline Q12.
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EFPIA CDEG position paper on the use of Form FDA 1572 for clinical trials performed outside the USA
The EFPIA Clinical Development Expert Group (CDEG) published the position paper providing recommendations on the use of Form FDA 1572 for non-IND sites.
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ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
On 18 February 2020 the EMA published the Step 5 on ICH E9 (R1) addendum on estimands and sensitivity in clinical trials.
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Orphan medicines in the EU
On 28 February 2020 the EMA published the leaflet on orphan medicines in the EU.
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Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
On 21 February 2020 the FDA announced the availability of the final guidance for industry.
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Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
On 19 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 20 April 2020.
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Good manufacturing practice
On 19 February 2020 the EMA updated the GMP guidelines.
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European Medicines Agency’s Privacy Statement
On 19 February 2020 the EMA published its privacy statement for the pre-employment medical examination.
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ICH S5 (R3) guideline on reproductive toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals
On 18 February 2020 the EMA published the Step 5 on ICH S5 (R3) guideline on reproductive toxicology.
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New Address for Widler & Schiemann AG in Zug
From 1 March 2020, the company Widler & Schiemamm AG has a new address: Baarerstrasse 75, 6300 Zug
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Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry
On 3 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 April 2020.
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European Medicines Agency’s privacy statement for public and targeted consultation
On 14 February 2020 the EMA published its privacy statement for public and targeted consultation.
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Products Management Services (PMS) -Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
On 11 February 2020 the EMA announced the availability of the guideline of implementation of the ISO IDMP standards.
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Substances, Products, Organisations, Referentials (SPOR)
On 11 February 2020 the EMA announced the availability of the SPOR Application Programming Interface (API) version 2 specification.
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ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
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ICH M9 guideline on biopharmaceutics classification system-based biowaivers
On 11 February 2020 the EMA announced that ICH M9 reached step 5 of the ICH process.
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European Medicines Agency privacy statement for the organisation of meetings and events
On 7 February 2020 the EMA published its privacy statement for the organisation of meetings and events.
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
On 6 February 2020 the EMA updated its pre-authorisation procedural advice for users of the centralised procedure.
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Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry
On 5 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 6 April 2020.
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Quality of medicines questions and answers: Part 1
On 05 February 2020 the EMA updated the questions and answers on matters related to the quality of medicines.
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EMA to support development of vaccines and treatments for novel coronavirus disease
On 04 February 2020 the EMA announced to support development of vaccines and treatments for novel coronavirus disease.
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Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment Guidance for Industry
On 4 February 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 3 April 2020.
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European Medicines Agency - Privacy statement for Selection and Recruitment
On 03 February 2020 the EMA updated its privacy statement for selection and recruitment.
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China Regulatory Policy Landscape snapshot and future perspective for Drugs and Biologics
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11 February 2020 at 10:00 AM Eastern Time (US and Canada) for the Regulatory Intelligence Working Group Monthly Meeting
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Ten recommendations to unlock the potential of big data for public health in the EU
On 20 January 2020 the joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposed ten priority actions for the European medicines regulatory network.
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Electronic product information for human medicines in the EU: key principles
On 29 January 2020 the EMA published the key principles outlining a harmonised approach to develop and use electronic product information (ePI) for human medicines across the EU.
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EMA supporting small and medium-sized enterprises (SMEs)
On 28 January 2020 EMA updated supporting SMEs.
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FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
On 28 January 2020 FDA announced that it continues its efforts to support innovators developing gene therapy products.
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Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment
On 24 January 2020 FDA announced the availability of the final guide for industry.
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Assessing User Fees Under the Biosimilar User Fee Amendments of 2017
On 23 January 2020 FDA announced the availability of the final guide for industry.
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Procedural advice for orphan medicinal product designation
On 21 January 2020 EMA updated this guidance for sponsors.
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Q&A on impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations
On 7 January 2020 EMA updated how the EU-USA Mutual Recognition Agreement (MRA) affects marketing authorisation applications or variations.
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Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
On 15 January 2020 FDA announced the availability of the guide for industry. Comments may submit by 16 March 2020.
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Mandatory use of international standard for the reporting of side effects to improve safety of medicines
On 15 January 2020 the EMA management board announced the confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology.
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IRIS guide for Parallel Distribution applicants
On 10 January 2020 EMA updated the IRIS guide for parallel distribution applicants.
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Human medicines: highlights of 2019
On 9 January 2020 EMA published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.
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4-Year Overview of Pharmacovigilance Activities in the EU Shows Robust and Effective Medicines Safety System
On 17 December 2019 the EMA released the report on the impact of pharmacovigilance measures covering the period 01 January 2015 to 31 December 2018.
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Brexit update: the United Kingdom's withdrawal from the European Union
On 20 December 2019 the EMA updated the UK withdrawal from the EU.
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MHRA phase I accreditation scheme
On 20 December 2019 the MHRA updated the List of Accredited Phase I Units.
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Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
On 20 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 21 February 2020.
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Bridging for Drug-Device and Biologic-Device Combination Products
On 18 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 18 February 2020.
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Launch of international pilot programme on inspection of manufacturers of sterile medicines
On 17 December 2019 the EMA updated the international collaboration on GMP inspections.
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Qualification Process for Drug Development Tools
On 12 December 2019 the FDA announced the availability of the draft guidance for industry and FDA staff. Comments may be submitted by 7 February 2020.
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Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women
On 11 December 2019 the EMA updated the guidelines on GVP.
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How will pharmacovigilance look in 2030?
On 10 December 2019 the EMA published the news about the predictions for the key elements of Pharmacovigilance in 2030.
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Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids
On 6 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 7 February 2020.
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Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment
On 4 December 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 2 February 2020.
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Guide on access to unpublished documents
On 9 December 2019 the EMA updated the guide on access to unpublished documents.
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China tightens drug administration as law takes effect
China's revised drug administration law, adopted by the top legislature in August, went into effect on Dec 1, as part of the country's efforts to strengthen supervision to ensure drug safety.
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ICH Q12 and Annexes reach Step 4 of the ICH Process
The ICH Q12 and its Annexes reached Step 4 of the ICH Process at the ICH meeting in Singapore on 21 November 2019.
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European Medicines Agency’s Privacy Statement concerning requests for information or access to documents
On 26 November 2019 the EMA published its privacy statement explaining requests for information or access to documents
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Would FDA support these approaches: Flipped Clinical Trials and One Indication, One Standardized Protocol, Multiple IMPs?
On 7 November 2019 the FDA held a public meeting on Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's Office of New Drugs
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Report from the Commission to the European Parliament and the Council on the National and European Medicines Agency Experience Regarding the List of Medicines for Human Use Subject to Additional Monitoring
On 15 November 2019 the European Commission published the report concerning the experience gained regarding Additional Monitoring
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Procedural advice for orphan medicinal product designation
On 19 November 2019 the EMA updated this guidance for sponsors.
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Transdermal and Topical Delivery Systems - Product Development and Quality Considerations
On 20 November 2019 the FDA announced the availability of the draft guidance for industry. Comments may be submitted by 19 February 2020.
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Certificates of Confidentiality
On 22 November 2019 the FDA announced the availability of the draft guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and FDA Staff. Comments may be submitted by 08 January 2020.
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Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
On 25 November 2019 the FDA announced the availability of the draft guidance for comments by 27 January 2020.
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Adaptive Designs for Clinical Trials of Drugs and Biologics
On 29 November 2019 the FDA announced the final guidance for industry. Adaptive designs for clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. They are intended to support the effectiveness and safety of drugs.
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How to handle remote monitoring?
EFGCP audit working party discussed the questions regarding to the remote monitoring.
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Status of ICH Guidelines implementation by ICH Regulatory Members
On 1 November 2019 a report of monitoring the adequacy of implementation and adherence to ICH guidelines available on the ICH website
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EudraVigilance Release Notes v.1.22
On 4 November 2019 the EMA updated the EudraVigilance Release Notes v1.22
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Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
On 7 November 2019 the FDA is establishing a public docket to collect comments on the draft document. Comments may be submitted by 6 January 2010
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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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