GMP News - Pharmaceutical Development / Clinical Trials / GCP

16.04.24

ICH E2D(R1) Draft Guideline on Post-Approval Safety Data

The ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period.

16.04.24

FDA issues Draft Guidance on Key Information in Informed Consent

The FDA published a draft guidance on key information in informed consent. Comments are due by 30 April 2024.

10.04.24

US FDA: Draft on Data Integrity for BE/BA Studies published

At the beginning of April 2024, the draft document "Data Integrity for In Vivo Bioavailability and Bioequivalence Studies" was published on the US FDA website and is now available for comment for 60 days. The document is intended to assist applicants and marketing authorisation holders in the area of data integrity for the clinical and bioanalytical part of bioequivalence and bioavailability studies.

14.03.24

EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs.

14.03.24

Improving Registration and Reporting Summary Results Information for Clinical Trials

The FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered and when and for which trials summary results information must be submitted.

14.03.24

Master Protocols for Drug and Biological Product Development

A new FDA guidance provides recommendations on the design and analysis of trials conducted under a master protocol as well as guidance on the submission of documentation to support regulatory review. Commenting on the proposed guideline was open until 22 February 2024.

05.03.24

FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products

At the end of December, the FDA published a new draft guidance document on potency assays for Cell and Gentherapeutics. In addition to recommendations for potency testing, this guidance is also intended to help with the overall strategy for ensuring potency.

28.02.24

FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

The FDA defines advanced manufacturing as innovative pharmaceutical manufacturing technologies or an approach with the potential to improve the reliability and robustness of the manufacturing and supply chain. The FDA encourages the early adoption of such advanced manufacturing technologies and has established a programme for this purpose.

20.02.24

Abbreviations in the GDP Environment - Extended List

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview first published a few months ago has now been extended.

08.02.24

FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products

Following recent cases of microbially contaminated ophthalmic drug products as well as safety recalls, the FDA published a revised draft guidance on Quality Attributes for Ophthalmic Drug Products, to include information about product sterility and preservative use. Moreover the revision clarifies that the guidance applies to all ophthalmic drugs, including over-the-counter (OTC) drugs and combination products.

25.01.24

Use of Digital Health Technologies (DHTs) to Acquire Data Remotely

Following the draft guideline published in March 2022 the FDA issued the final guidance that provides industry, investigators and others with recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical trials.

25.01.24

FDA Exception from the Requirement to obtain Informed Consent

The FDA issued a final rule to help advance medical product development without compromising the rights, safety and welfare of trial participants. The rule provides an exception from the requirement to obtain informed consent when a clinical trial poses no more than minimal risk to the participants.

25.01.24

EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India

Following a good clinical practice (GCP) inspection which showed irregularities in study data, the EMA has recommended the suspension of marketing authorizations of a number of generic medicines tested by a contract research organisation (CRO) located in India.

19.12.23

FDA enhances Adoption of Innovative Clinical Trial Designs

FDA's Center for Drug Evaluation and Research (CDER) announced that the center is soliciting public comments to understand the state of innovation in clinical trial design and conduct. The CDER is gathering information from internal and external stakeholders on the barriers and facilitators to incorporating innovative clinical trial approaches in drug development programs.

19.12.23

CTR / CTIS Guidance Update

The EMA and the HMA published revised guidance documents relating to the CTIS transparency rules and the transition of clinical trials. Amongst others, the concept of consolidated protocols has been clarified by providing an example illustrating the transition of a CTD trial to the CTR with different protocol versions approved in the Member States Concerned.

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GMP News - Pharmaceutical Development / Clinical Trials / GCP

ICH E2D(R1) Draft Guideline on Post-Approval Safety Data

FDA issues Draft Guidance on Key Information in Informed Consent

US FDA: Draft on Data Integrity for BE/BA Studies published

EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

Improving Registration and Reporting Summary Results Information for Clinical Trials

Master Protocols for Drug and Biological Product Development

FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products

FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

Abbreviations in the GDP Environment - Extended List

FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products

Use of Digital Health Technologies (DHTs) to Acquire Data Remotely

FDA Exception from the Requirement to obtain Informed Consent

EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India

FDA enhances Adoption of Innovative Clinical Trial Designs

CTR / CTIS Guidance Update

Recommended Event

Handling Changes and Variations

GMP News - Pharmaceutical Development / Clinical Trials / GCP

ICH E2D(R1) Draft Guideline on Post-Approval Safety Data

FDA issues Draft Guidance on Key Information in Informed Consent

US FDA: Draft on Data Integrity for BE/BA Studies published

EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

Improving Registration and Reporting Summary Results Information for Clinical Trials

Master Protocols for Drug and Biological Product Development

FDA Draft Guidance on Potency Assays for Cellular and Gene Therapy Products

FDA Guideline "Advanced Manufacturing Technologies Program" published as a Draft

Abbreviations in the GDP Environment - Extended List

FDA Revision to the Guidance on Quality Considerations for Ophthalmic Drug Products

Use of Digital Health Technologies (DHTs) to Acquire Data Remotely

FDA Exception from the Requirement to obtain Informed Consent

EMA recommends Suspension of Medicines following GCP Inspection of a CRO in India

FDA enhances Adoption of Innovative Clinical Trial Designs

CTR / CTIS Guidance Update

Recommended Event

Handling Changes and Variations

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