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: 01 January 2017
Document: Assessment of Abuse Potential of Drugs
Region: US
Description: This guidance is intended to assist sponsors of investigational new drugs and applicants for approval of a new drug in evaluating whether their new drug product has abuse potential. This guidance also provides recommendations to applicants who intend to submit new drug applications (NDAs) for prescription drug products that may have abuse potential.
URL: click here
Date: 01 November 2016
Document: Non-Inferiority Clinical Trials to Establish Effectiveness
Region: US
Description: This document provides guidance to sponsors and applicants submitting investigational drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic, usually because a superiority study design (drug versus placebo, dose response, or superiority to an active drug) cannot be used.2 The guidance gives advice on when NI studies intended to demonstrate effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis. This guidance does not provide recommendations for the use of NI study designs to evaluate the safety of a drug.
URL: click here
Date: 01 October 2016
Document: Collecting Race and Ethnicity Data in Clinical Trials
Region: US
Description: The purpose of this guidance is to provide FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. Using standard terminology for age, sex, gender, race, and ethnicity helps ensure that subpopulation data is collected consistently.
URL: click here
Date: 01 February 2016
Document: Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations
Region: US
Description: Guidance on selective safety data collection in late phase clinical trials based on safety profile of product
URL: click here
Date: 30 March 2015
Document: Guidance for Industry: Critical Path Innovation Meetings
Region: US
Description: This new guidance describes the procedures and appropriate topics for researchers to discuss with FDA methodologies or technologies which may be useful to enhance drug development
URL: click here
Date: 21 January 2015
Document: Joint Letter of Intent for Qualification of Novel Methodologies
Region: US
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: 17 December 2014
Document: Regulatory Submissions In Electronic Format
Region: US
Description: FDA has issued guidance for electronic submission of study data for INDs and NDAs. This is now mandatory except for noncommercial INDs
URL: click here
URL 2: click here
Date: 21 November 2014
Document: Drug Trials Snapshot
Region: US
Description: The FDA has developed Drug Trials Snapshots to provide information to the public about who participated in the clinical trials for new FDA approved drugs. Drug Trials Snapshot is part of a pilot project to provide information about the sex, age, race and ethnicity of clinical participants for a small group of recently approved drugs.
URL: click here
Date: 01 June 2014
Document: Guidance for Industry - Qualification Process for Drug Development Tools
Region: US
Description: “This guidance describes the process for qualifying drug development tools intended for potential use, over time, in multiple drug development programs. Drug development tools (DDTs) are methods, materials, or measures that aid drug development. DDTs include, but are not limited to, biomarkers, clinical outcome assessments (COAs), and animal models for drug development under the Animal Rule. This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.”
URL: click here
Date: 30 May 2014
Document: Guidance for Industry -Expedited Programs for Serious Conditions – Drugs and Biologics
Region: US
Description: The following four FDA programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life- threatening condition: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. The purpose of this guidance for industry is to provide a single resource for information on FDA’s policies and procedures for these four programs as well as threshold criteria generally applicable to concluding that a drug is a candidate for these expedited development and review programs.
URL: click here
Date: 13 May 2014
Document: DRAFT Guidance: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
Region: US
Description: This guidance is open for comment and provides guidance on developingclinical pharmacology studies to demonstrate biosimilarity
URL: click here
Date: 17 March 2014
Document: Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
Region: US
Description: This DRAFT guidance contains advice on how to meet the  BA and BE requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for  oral administration.
URL: click here
Date: 01 January 2014
Document: Guidance for Industry and FDA Staff: Qualification Process for Drug Development Tools
Region: US
Description: "This guidance describes the process for qualifying drug2 development tools intended for potential use, over time, in multiple drug development programs. Drug development tools (DDTs) are methods, materials, or measures that aid drug development. DDTs include, but are not limited to, biomarkers, clinical outcome assessments (COAs), and animal models for drug development under the Animal Rule.3 This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT."
URL: click here
Date: 01 December 2013
Document: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
Region: US
Description: DRAFT guidance for consultation - 90 days from 5 Dec 2013
URL: click here
Date: 01 September 2013
Document: Electronic Source Data in Clinical Investigations
Region: US
Description: FDA has finalised its guidance on Electronic Source Data in Clinical Investigations. This covers data capture, data review, retention of records and access to records. There's also a chapter on the use and description of computerized systems in clinical investigations and some of the requirements for them.
URL: click here
Date: 01 September 2013
Document: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND
Region: US
Description: There is a new guideline on INDs and specifically on determining whether a human research study can be done without an IND. “This guidance describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.”
URL: click here
Date: 01 August 2013
Document: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
Region: US
Description: The guidance on Risk Based Approaches to Monitoring is now final and is covered in a separate article in the Journal of Clinical Research and GCP
URL: click here
Date: 01 December 2012
Document: Safety Reporting Requirements for INDs and BA/BE Studies
Region: US
Description: There is new FDA guidance on safety reporting in clinical trials, this is following on from revision of the safety reporting regulation. The guidance covers requirements for annual reporting of safety and also expedited submission of SUSARs.
URL: click here
Date: 01 December 2012
Document: Safety Reporting Requirements for INDs and BA/BE Studies- Small Entity Compliance Guide
Region: US
Description: There is additional FDA guidance on Safety Reporting for small organisations to help them understand and implement the new requirements.
URL: click here
Date: 01 February 2012
Document: IRB Continuing Review after Clinical Investigation Approval
Region: US
Description: FDA has issued final guidance on IRB continuing review following clinical investigation approval. This guideline states that IRBs shoud review ongong clinical trials at least annually and should assess which trials require more frequent review.
URL: click here
Date: 01 January 2012
Document: Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling
Region: US
Description: FDA has published guidance on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling. This guidance looks at the benefits of considering genetic influences on effectiveness and toxicity of medicines and approaches to assessing these during drug development
URL: click here
Date: 07 March 2011
Document: 21 CFR part 50
Region: US
Description: Addition to information required to be given to clinical trial subjects: that clinical trial information will be entered into the national clinical trial databank. FDA has also made clear that entry of this information into the databank is required by law.
URL: click here
Date: 01 March 2011
Document: Exception from Informed Consent Requirements for Emergency Research
Region: US
Description: FDA has issued guidance on Exceptions From Informed Consent Requirements For Emergency Research. This guidance supplements the 1996 regulations in 21 CFR 50.24 which covers the situation where it is necessary to enter subjects into a clinical trial who cannot give consent for themselves and where timely consent from a legal representative is not feasible.
URL: click here
Date: 10 December 2010
Document: MAPP: Good Review Practice: Clinical Review Template
Region: US
Description: A new Manual of Policies and Procedures (MAPP) template has been issued for FDA staff covering Clinical Review under Good Review Practice. This template should be used by FDA reviewers reviewing NDAs.
URL: click here

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