GMP News Drug Safety/Pharmacovigilance

02.05.23

Major Reform of UK Clinical Trials Regulation

The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

more

02.05.23

EMA's Q&As on Raw Data from Clinical Trials

The EMA issued an updated Questions and Answers document with information about the previously announced raw data proof-of-concept (PoC) pilot for industry. Will the Raw Data Analysis lead to more GCP Inspections?

more

02.05.23

FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides additional recommendations on the risk-based approach to validation of electronic systems.

more

26.04.23

USP Draft Chapters for Glass and Plastic Packaging Systems

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.

more

18.04.23

St. John's Wort: Updated EU Herbal Monograph

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

more

11.04.23

Manufacture of IMPs - When is it Reconstitution?

Following the Brexit, the UK clinical trials regulations differ from those in the EU Member States. Therefore, the British MHRA published on their blog a post on the manufacture of Investigational Medicinal Products (IMPs).

more

11.04.23

Clinical Trials Regulation - Version 6.4 of the Q&As

The European Commission published an updated Version 6.4 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). A new Q&A has been added for the case where the sponsor of a clinical trial is not the product owner of the IMP and should not have access to the quality IMPD in order to protect commercially confidential information.

more

11.04.23

Final GCP Guideline on Computerized Systems and Data Integrity

The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.

more

05.04.23

FDA Stops Voluntary Cosmetic Registration Program

The FDA has stopped accepting submissions to the Voluntary Cosmetic Registration Program (VCRP) effective March 27, 2023. This follows the agency's plans to develop a program for submission of the facility registrations and product listings mandated by the "Modernization of Cosmetics Regulation Act" (MoCRA). According to the agency, the new law gives the FDA new authorities that will help ensure the safety of cosmetic products.

more

14.03.23

Recommendations on Decentralized Elements in Clinical Trials

The EU Commission has supplemented the area of clinical trials with "Recommendations on decentralized elements in clinical trials". The paper deals with procedures that, due to new approaches and advanced technical possibilities, can now take place outside study centers.

more

14.03.23

CTIS: EMA´s Risk Mitigation Plan

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios. In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed.

more

10.03.23

Consultation on Multi-Stakeholder Platform for improving EU Clinical Trials

The EMA published a Concept Paper and a Press Release on a multi-stakeholder platform to support discussions in the clinical research landscape. The deadline for comments is 3 March 2023.

more

10.03.23

CTIS & CTR: Sponsor Questions & Answers

EMA's Query Management Working Group prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation.

more

10.03.23

CTR & CTIS: Quick Guide for Sponsors

A quick guide on the main rules and procedures of the Clinical Trials Regulation (CTR) has been released for sponsors who wish to conduct clinical trials in the European Union (EU) / European Economic Area (EEA) or have ongoing clinical trials in this region.

more

10.03.23

CTIS: Questions and Answers on Data Protection

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection. The Q&A document has been created to provide guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics