PharmaSchool Regulatory Updates

PharmaSchool GCP & Regulatory Updates are notifications about changes, additions and new documents relating to the conduct of Clinical Trials. These are updated as and when new information is available. If you know of a document that should be referenced in this section then please let us know by emailing editor@pharmaschool.co

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Date: 28 June 2017
Document: Auxiliary Medicinal Products in Clinical Trials
Region: EU
Description: This Recommendation revises the previous document entitled "Guidance on Investigational Medicinal Products (IMPs) and "non investigational medicinal products" (NIMPs)" in light of the new requirements in the EU Regulation on Clinical Trials due to apply in 2018
URL: click here
Date: 16 June 2017
Document: Final summary record – EDC systems and risk-based monitoring in Clinical Trials
Region: EU
Description: This document is a report from a meeting of the GCP Inspectors Working group and discusses the requirements of ICH E6(R2) with regard to electronic records.
URL: click here
Date: 25 April 2017
Document: Risk proportionate approaches in clinical trials
Region: EU
Description: This recommendation provides advice on taking a risk based approach to such issues as Quality Management, Safety Reporting, IMP management, Monitoring and document management.
URL: click here
Date: 01 April 2017
Document: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use
Region: EU
Description: This guidance document contains information on phase I of the EMA policy on publication of clinical trial data - i.e. publication of clinical study reports. It includes information on anonymisation and redaction of information in the CSRs
URL: click here
Date: 01 April 2017
Document: Questions and Answers (Q&As) on the External Guidance of Policy 0070 on Clinical Data Publication (CDP)
Region: EU
Description:
URL: click here
Date: 01 March 2017
Document: Procedure for reporting of GCP inspections requested by the Committee for Medicinal Products for Human Use (CHMP)
Region: EU
Description: Updated guidance for EU inspectors on reporting of EMA requested GCP Inspections
URL: click here
Date: 01 March 2017
Document: Guidance on triggers for inspections of bioequivalence trials: Quick scan
Region: EU
Description: Guidance for EMA staff on reviewing bioequvalence trials to identify when an inspection may be necessary.
URL: click here
Date: 26 January 2017
Document: Summaries of Clinical Trial Results for Laypersons
Region: EU
Description: This recommendation provides advice on the Summarywhich will be required by the new EU Clinical Trials Regulation.
URL: click here
Date: 01 August 2016
Document: Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev 2)
Region: EU
Description: Updates to requirements for submission and registration of non-interventional PASS
URL: click here
Date: 01 August 2016
Document: Module VIII – Post-authorisation safety studies (Rev 2)
Region: EU
Description: Clarification and updating of various sections
URL: click here
Date: 01 June 2016
Document: Annual Report of EMA GCP Inpsectors Working Group 2015
Region: EU
Description: Summary of findings fromEMA initiated inspections conducted in 2015
URL: click here
Date: 08 June 2015
Document: Q&A on EMA policy on publication of clinical trial results
Region: EU
Description: This updated document covers the background and evolution of the policy and provides some information about the implementation of the policy and about the redaction of commercially confidential information
URL: click here
Date: 22 May 2015
Document: Classification of Advanced Therapy Medicinal Products
Region: EU
Description: To supplement the legislation on ATMPs this guideline provides definitions and criteria for the various types of ATMP.
URL: click here
Date: 25 March 2015
Document: Functional specifications for the EU portal and EU database to be audited
Region: EU
Description: This document outlines the functionality of the new database and central portal being developed to allow implementation of the new EU Clinical Trials Regulation
URL: click here
Date: 26 February 2015
Document: Guideline on adjustment for baseline covariates in clinical trials
Region: EU
Description: This guideline replaces an old one and covers adjustment of covariates where there is an association between baseline covariates and primary outcome measures. The main change relates to the use of dynamic allocation methods.
URL: click here
Date: 10 February 2015
Document: EMA explains its redaction rules
Region: EU
Description: Following on from publication of the EMA policy on publication of clinical trial results EMA has published an explanation of the redaction of commercially confidential information.
URL: click here
Date: 21 January 2015
Document: Updates to PIP information
Region: EU
Description: Several forms have been updated following and update to the PIP guidance. Also the Q&A document relating to PIPs has been updated. The changes relate to application, re-examination and compliance check.
URL: click here
Date: 21 January 2015
Document: New International Standard for safety reporting
Region: EU
Description: Relating to ICH E2B (R3) the EMA has issued a guidance document to facilitate implementation of the ISO standard for Indivdual Case Safety Reports from July 2016
URL: click here
URL 2: click here
Date: 21 January 2015
Document: Public consultation on the implementation of transparency requirements in the European Clinical Trials Regulation
Region: EU
Description: EMA has begun a public consultation process to look at how the new transparency requirements will be implemented. Specifically it's looking at the functional specifications for the central database in terms of transparency requirements.
URL: click here
URL 2: click here
Date: 05 January 2015
Document: Joint Letter of Intent for Qualification of Novel Methodologies
Region: EU
Description: EMA and FDA have published a joint standard Letter of Intent so that applicants for qualificiation of novel methodologies can sbumit the same letter to both FDA and EMA if they wish.
URL: click here
Date: 15 December 2014
Document: Adaptive pathways pilot project
Region: EU
Description: EMA has published a document outlining their experience with a pilot project on adaptive licensing, to facilitate patients' earlier access to new treatments.
URL: click here
Date: 01 December 2014
Document: Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP
Region: EU
Description: EMA has published a summary of the findings from CHMP requested inspections conducted in 2012. This provides useful information on the key inspection findings in the EU.
URL: click here
Date: 24 November 2014
Document: Guidance on access to unpublished documents
Region: EU
Description: The European Medicines Agency (EMA) has released a practical guide detailing the process for requesting access to unpublished documents held by the Agency.
URL: click here
Date: 20 November 2014
Document: Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms
Region: EU
Description: The primary purpose of this guideline is to define the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified release formulations following oral, intramuscular and subcutaneous administration and transdermal dosage forms in man and to set out general principles for designing, conducting and evaluating such studies. The revision of the Note for Guidance on the Investigation of Bioavailability and Bioequivalence (EWP/QWP/1401/98) generated the necessity of consequential adjustments. Furthermore the guideline provides updated requirements for transdermal drug delivery systems (TDDS) and addresses recommendations for specific modified release formulations, e.g. for intramuscular/subcutaneous depot formulations.
URL: click here
Date: 02 October 2014
Document: European Medicines Agency policy on publication of clinical data for medicinal products for human use
Region: EU
Description: This policy has been amended following consultation. This policy addresses access to clinical study reports and states that their policy on access to Individual Patient Data (IPD) needs more discussion and consultation. The policy is also prospective only and does not cover access to retrospective data. There is also a Q&A document.
URL: click here
Date: 19 September 2014
Document: European Medicines Agency Guidance for applicants seeking scientific advice and protocol assistanc
Region: EU
Description: Updated guidance on the process for seeking regulatory scientific advice on protocol and product development
URL: click here
Date: 14 July 2014
Document: Guide on methodological standards in pharmacoepidemiology
Region: EU
Description: This document has been revised to include a chapter on pharmacogenetic studies
URL: click here
Date: 19 June 2014
Document: EUDRACT
Region: EU
Description: Posting of results of interventional clinical trials in the EUDraCT database has become mandatory from 21 July 2014. Results of clinical trials ending on or after this date must be entered within 6 or 12 months of the end of the trial depending on the type of trial. This information will also be publicly available.
URL: click here
Date: 22 May 2014
Document: Annual report of the Good Clinical Practice Inspectors Working Group 2013
Region: EU
Description: This report contains details of the inspections conducted by EU GCP inspectors, including numbers and locations and summaries of the main findings.
URL: click here
Date: 11 April 2014
Document: Delegated Act: as regards situations in which post-authorisation efficacy studies may be required
Region: EU
Description: Further supplementing the Pharmacovigilance rules this act outlines the process for the regulatory authorities to decide if postmarketing efficacy studies (PAES) are to be required as a condition of marketing authorisation
URL: click here
Date: 08 April 2014
Document: Announcement of final steps for clinical trial data policy
Region: EU
Description: The EMA will launch a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical-trial data at the beginning of May. This will give key stakeholders and the Agency the opportunity to address any outstanding issues before the final policy is presented to the EMA's Management Board for endorsement in June 2014.
URL: click here
Date: 02 April 2014
Document: Adoption of new EU Regulation on Clinical Trials
Region: EU
Description: The lastest draft of the new legislation has been formally approved by the European Parliament. We will publish more information in future about the changes this will make. Implementation is dependent on the development of a single online portal for CTA submissions and so we don't have a date for implementation yet, but previously they have said it's likely to be 2016.
URL: click here
Date: 11 February 2014
Document: Q&As on Paediatric Investigation Plan
Region: EU
Description: Some of the questions have been updated and a couple of new ones have been added
URL: click here
Date: 11 February 2014
Document: Requirement for Unique Product Identifiers
Region: EU
Description: EMA has introduced these numbers to track products through the development process, so for all new products companies will need to complete a UPI Registration form to obtain this number
URL: click here
Date: 10 February 2014
Document: EMA to publish all clinical reports from 1 January 2015
Region: EU
Description: "The European Medicines Agency (EMA) has decided to publish the clinical reports that underpin the decision-making on medicines. Following extensive consultations held by the Agency with patients, healthcare professionals, academia, industry and other European entities over the past 18 months, the EMA Management Board unanimously adopted the new policy at its meeting on 2 October 2014. The policy will enter into force on 1 January 2015. It will apply to clinical reports contained in all applications for centralised marketing authorisations submitted after that date. The reports will be released as soon as a decision on the application has been taken."
URL: click here
Date: 10 February 2014
Document: EMA policy on publication of clinical trial data
Region: EU
Description: Final version has now been published and will come into effect in January 2015
URL: click here
Date: 30 January 2014
Document: DRAFT guidance on use of pharmacogenomics to improve safety monitoring of medicines
Region: EU
Description: Open for public consultation until 30 July 2014
URL: click here
Date: 01 January 2014
Document: Latest DRAFT of new Clinical Trials Regulation
Region: EU
Description: This draft has been approvedby the Permanent Representatives Committee in December 2013 and is planned to go before the European Parliament in April 2014
URL: click here
Date: 11 December 2013
Document: Overview of patient recruitment and the geographical location of investigator sites
Region: EU
Description: EMA published a report on the geographical spread of patients in clinical trials used in marketing authorisations in the EU. Over 60% of patients were outside the EU.
URL: click here
Date: 13 November 2013
Document: Updates on development of the EMAs Clinical Trials Transparency policy
Region: EU
Description: The EMA has updated this page to include more information about development of this policy. This is a very hot topic and because there is a great deal of discussion the finalisation of the policy is likely to be delayed.
URL: click here
Date: 29 October 2013
Document: Report: Workshop on the patient's voice in the evaluation of medicines
Region: EU
Description: This report comes out of a meeting looking at ways to involve patients more in the development and evaluation of medicines
URL: click here
Date: 10 October 2013
Document: Questions & Answers: Positions on specific questions addressed to the pharmacokinetics working party
Region: EU
Description: This document covers specific questions posed to the Pharmacokinetics working group on topics such as bioequivalence studies, food interactions etc.
URL: click here
Date: 09 October 2013
Document: Consultation on revision of PIP guideline
Region: EU
Description: Revision on the guideline covering format and contentof PIPs is underway and the consulation period ends on 3 Jan 2014
URL: click here
Date: 12 September 2013
Document: Mandate, objectives and rules of procedure Good Clinical Practice Inspectors Working Group
Region: EU
Description: The GCP Inspectors Working Group provides input and recommendations on all matters relating directly or indirectly to GCP in the context of clinical trials and/or any marketing authorisation procedures
URL: click here
Date: 30 July 2013
Document: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies
Region: EU
Description: Updated EMA guideline on the content and format of Final Study Reports for non-interventional PASS.
URL: click here
Date: 17 July 2013
Document: Points to consider for assessors, inspectors and EMA inspection coordinators on the identification of triggers for the selection of applications for “routine” and/or “for cause” inspections, their investigation and scope of such inspections
Region: EU
Description: The EMA's GCP Inspectors Working Group has produced a document outlining guidance for inspectors and assessors on triggers for selection of applications for routine and for cause inspections. It describes the process for selection of trials and sites for routine inspections and also specific issues which might suggest a need for a for cause inspection, such as ethical or administrative issues, or questions over the evaluation and interpretation of the data.
URL: click here
Date: 03 July 2013
Document: Guidance on triggers for inspections of bioequivalence trials
Region: EU
Description: Specific guidance document on triggers for inspections of bioequivalence trials
URL: click here
Date: 01 July 2013
Document: Post-authorisation safety studies: questions and answers
Region: EU
Description: Updated Q&A page for PASS explaining the EMAs position on issues which often come up.
URL: click here
Date: 01 July 2013
Document: Submission of Article-46 paediatric studies: questions and answers
Region: EU
Description: There is a question and answer page about submission of post-authorisation paediatric studies (which have to be submitted within 6 months under the Paediatric Regulation)
URL: click here
Date: 24 June 2013
Document: General report on experience acquired as a result of the application of Regulation (EC) No 1901/2006 on medicinal products for paediatric use
Region: EU
Description: EMA has published two reports on the implementation of the Paediatric Regulation. The reports highlight the experience gained and the successes achieved in the first 5 years.
URL: click here
Date: 22 May 2013
Document: Orphan Designation
Region: EU
Description: EMA has updated the procedure for Orphan Medicinal Product Designation andalso updated several of the other guidelines on Orphan products
URL: click here
Date: 19 April 2013
Document: Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies
Region: EU
Description: The changes appear to be mainly clarifications of the scope and some definitions in the guidance.
URL: click here
Date: 19 March 2013
Document: Concept paper on extrapolation of efficacy and safety in medicine development - See more at: http://www.crgcp.com/articles2.asp?article=002008#sthash.efu99wyz.dpuf
Region: EU
Description: Extrapolation may be generally defined as: ‘Extending information and conclusions available from studies in one or more subgroups of the patient population (source population), or in related conditions or with related medicinal products, to make inferences for another subgroup of the population (target population), or condition or product, thus reducing the need to generate additional information (types of studies, design modifications, number of patients required) to reach conclusions for the target population, or condition or medicinal product."
URL: click here
Date: 28 January 2013
Document: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies
Region: EU
Description: There is a new EMA guideline on the content and format of Final Study Reports for non-interventional PASS. Obviously interventional post marketing research is subject to the CT Directive, but non-interventional PASS research should also be written up and this guideline outlines the requirements for these reports
URL: click here
Date: 22 January 2013
Document: TECHNICAL GUIDANCE ON THE FORMAT OF THE DATA FIELDS OF RESULT-RELATED INFORMATION ON CLINICAL TRIALS SUBMITTED IN ACCORDANCE WITH ARTICLE 57(2) OF REGULATION (EC) NO 726/2004 AND ARTICLE 41(2) OF REGULATION (EC) NO 1901/2006
Region: EU
Description: The EMA has published technical guidance on data fields in the results section in the EUDRACT database.
URL: click here
Date: 07 December 2012
Document: Reflection paper on classification of advanced therapy medicinal products
Region: EU
Description: There is a reflection paper issued by the Committee on Advanced Therapies which provides guidance on classification of Advanced Therapy Medicinal Products (ATMPs). It states that “The ATMP classification is a non-mandatory, free of charge, legally non-binding procedure that helps developers to clarify the applicable regulatory framework.”
URL: click here
Date: 06 October 2012
Document: Commission Guideline — Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006
Region: EU
Description: The EMA has published guidance on posting and publication of result-related information on clinical trials. This is the implementation of the results section in the EUDRACT database, and the posting and publication is also considered to be the submission of the Clinical Trial summary report section of the end of trial notification to the regulatory authority and Ethics Committee.
URL: click here
Date: 19 September 2012
Document: Points to consider on GCP inspection findings and the benefit-risk balance
Region: EU
Description: EMA has published guidance for GCP inspectors entitled “Points to consider on GCP inspection findings and the benefit-risk balance”. This guideline categorises the types of inspection findings which may affect the risk benefit balance for a product and provides guidance for inspectors in writing inspection reports and also for assessors when reviewing marketing applications.
URL: click here
Date: 02 July 2012
Document: Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies
Region: EU
Description: As part of the implementation of the new pharmacovigilance legislation the EMA has issued guidance on post marketing safety studies (PASS). This guideline covers both clinical trials and non-interventional PASS, and sets out scientific and ethical guidance as well as talking about research which is required as a condition of licence approval.
URL: click here
Date: 12 June 2012
Document: Guideline on the Investigation of Drug Interactions
Region: EU
Description: EMA has updated its guidance on the investigation of drug interactions. “The scope of this guideline is to provide advice and recommendations on how to evaluate the potential for drug-food and drug-drug interactions for medicinal products (including herbal medicinal products) and how to translate the results of these evaluations to appropriate treatment recommendations in the labelling.”
URL: click here
Date: 30 May 2012
Document: Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
Region: EU
Description: EMA has finalised and published this guidance
URL: click here
Date: 03 May 2012
Document: Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
Region: EU
Description: This document supplements the CTA guidance by outlining additional requirements for the IMPD for biological products. It also provides examples of changes to the Biological product which would constitute substantial amendments of the IMPD and/or CTA.
URL: click here
Date: 13 April 2012
Document: Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
Region: EU
Description: This guidance is about development and evaluation of products containing genetically modified cells, including of course clinical trials.
URL: click here
Date: 11 April 2012
Document: Eudralex Volume 10, Questions and Answers
Region: EU
Description: The Q&A document in chapter 5 of Eudralex Vol 10 has been updated with one new question. The question asks how long Annual Safety Reports have to be submitted in a member state. The answer is until subjects are no longer being treated in that member state, and this is expected to be last subject last visit unless otherwise specified in the protocol.
URL: click here
Date: 01 January 2012
Document: Qualification of novel methodologies for drug development: guidance to applicants
Region: EU
Description: EMA have issued guidance on qualification of novel methodologies for drug development. According to the document “The EMA qualification process is a new, voluntary, scientific pathway leading to either a CHMP opinion or a Scientific Advice on innovative methods or drug development tools” and encompasses things like imaging methods or biomarkers, or any other new methodology which you wish to use in pre-clinical or clinical trials
URL: click here
Date: 01 January 2012
Document: Q&A: Good Clinical Practice
Region: EU
Description: EMA now has a GCP Q&A section on their website which addresses various issues.
URL: click here
Date: 12 December 2011
Document: Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products
Region: EU
Description: A guideline on the use of pharmacogenetic methodologies in drug development in products where genetics has an influence on pharmacokinetics. The guideline discusses situations where pharmacogenetics should be used and then the requirements and recommendations for those situations.
URL: click here
Date: 01 September 2011
Document: MedDRA
Region: EU
Description: MedDRA is updated twice per year and all updates can be found on the MedDRA website
URL: click here
Date: 01 August 2011
Document: Eudralex Volume 10, Questions and Answers
Region: EU
Description: The Q&A document in Eudralex Vol10 chapter V has been amended again. Two new questions have been added: 1.7 and 4.1. Also two questions on safety reporting have been removed as these are now covered in the updated adverse event reporting guidance in Chapter II.
URL: click here
Date: 07 July 2011
Document: Responses to proposed revision of the Clnical Trials Directive
Region: EU
Description: A summary of the responses to the proposed revision to the Clinical Trials Directive has been published.
URL: click here
Date: 13 June 2011
Document: Methodological Standards for Pharmacoepidemiology
Region: EU
Description: There is revised guidance from ENCePP on Methodological Standards for Pharmacoepidemiology. This provides information on governance requirements, study design, data sources, statistical analysis plan, quality control and safety reporting.
URL: click here
Date: 11 June 2011
Document: Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use
Region: EU
Description: The EMA has issued a revision to the guidance on reporting adverse events in chapter 2 of Eudralex Vol 1. This revision replaces the following three documents:?Revision 2 of the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use; Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module); Questions & Answers specific to adverse reaction reporting in clinical trials
URL: click here
Date: 01 June 2011
Document: Questions and answers: Paediatric-investigation-plan guidance
Region: EU
Description: There is a Q&A section on Paediatric Investigation Plans (PIPs) on the EMA website. This is for applicants and covers lots of potential questions on the requirements and process for PIP submission.
URL: click here
Date: 18 March 2011
Document: Eudralex Volume 10, Questions and Answers
Region: EU
Description: The Q&A document in Eudralex vol 10 chapter 5 has been updated to include a new question on clinical trials involving both a medical device and a medicinal product.
URL: click here
Date: 01 March 2011
Document: GUIDANCE ON INVESTIGATIONAL MEDICINAL PRODUCTS (IMPS)
Region: EU
Description: The EMA has issued an updated guideline on IMPs and Non-IMPs which includes a new appendix (Appendix 2) covering requirements for the Non-IMP Dossier. It covers the various different options depending on the type of non-IMP you are using.
URL: click here
Date: 14 January 2011
Document: Reflection paper on stem cell-based medicinal products
Region: EU
Description: EMA has issued a new guideline on medicinal products based on stem cells which covers clinical research issues and requirements as well as quality and non-clinical guidance.
URL: click here

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