GMP News - Pharmaceutical Development / Clinical Trials / GCP

11.07.19

Updated Version of the Clinical Trials Regulation Questions & Answers Paper

The European Commission (EC) published an updated Version 2 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, 47 Q&As on safety have been included.

11.07.19

News from the clinical trial portal and database

The new CTR becomes applicable six months after the notice of the full functionality of the CTIS. The EMA informed that the CTIS now enters a phase of agile, iterative delivery, to prepare the system for audit.

10.07.19

Creams, Gels & Pastes redefined

A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa.

24.06.19

MHRA reports serious GCP breaches including Data Integrity

The British Medicines and HealthCare Regulatory Agency (MHRA) recently published the 2018 metrics report for serious GCP breaches reported to the agency.

24.06.19

The ICH publishes E8(R1) Draft Guideline for comment

The ICH E8(R1) draft Guideline on General Considerations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.

12.06.19

MHRA plans to apply AQbD principles

The MHRA plans to apply analytical quality by design principles, including the analytical target profile (ATP), to its pharmacopoeia (BP).

29.05.19

Revised USP chapter <3> Topical and Transdermal Product Quality Tests

The revised USP general chapter <3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has been approved.

28.05.19

How to manage Safety Data in a blinded Trial?

The MHRA Inspectorate recently clarified the agency´s expectations regarding the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs.

28.05.19

FDA´s final REMS Guideline

The US FDA affirms its commitment to efficient adoption of Risk Evaluation and Mitigation Strategy (REMS) plans and to making sure they do not impede generic drug development.

15.05.19

How does the GDPR impact Clinical Trials?

The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).

08.05.19

Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

04.04.19

Brexit: Importation of IMPs from approved countries in a no deal scenario

The MHRA recently provided guidance on how the management and oversight of the import of investigational medicinal products (IMPs) from listed countries will work in a no deal scenario.

04.04.19

Monitoring of Clinical Investigations: FDA´s Q&As on Data Integrity

The FDA provided additional guidance on risk-based monitoring for effective oversight, including Data Integrity. Read more on FDA`s draft Guidance for Industry A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.

21.03.19

FDA´s Pilot Program for Established Conditions

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced a new pilot program where sponsors can propose established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA) or as a prior approval supplement (PAS).

21.03.19

Is the review of the Audit Trail required in Clinical trials?

The MHRA recently provided guidance on Data Integrity in clinical trials. Is the review of the audit trail required?

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