GMP News Drug Safety/Pharmacovigilance

26.10.23

EMA Publishes revised CTIS Transparency Rules

The EMA has endorsed the revised transparency rules for the EU Clinical Trials Information System (CTIS). According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.

more

26.10.23

Key Factors for Compassionate Use

The FDA published a draft guidance for institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions (IPEAS).

more

26.10.23

FDA's final Guidance on Real-World Data and Real World Evidence

The U.S. Food and Drug Administration (FDA) issued the final guidance for the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to support regulatory decision-making for drugs and biological products. What are the sponsor's responsibilities?

more

25.10.23

FDA Publishes Structured Product Labeling Guide for Cosmetic Products

The U.S. Food and Drug Administration has published an updated structured product labeling (SPL) implementation guide with validation procedures for cosmetic product facility registrations and product listings.

more

18.10.23

Ozempic Falsifications: BfArM starts Investigation

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.

more

04.10.23

EMA: Q&As on the Topic of "Parallel Distribution" updated

Once again, the "Frequently asked questions about parallel distribution" have been revised and published on the EMA website. The information provided by the EMA on parallel distribution of centrally authorised medicinal products is set out in the Q&A in six paragraphs.

more

28.09.23

Annual Report Forms for Postmarketing Requirements

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.

more

28.09.23

FDA issues Final Guidance on Informed Consent

The U.S. Food and Drug Administration (FDA) issued the final document, "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors". Amongst others, the guidance clarifies who is responsible for the specific areas related to informed consent that should be considered.

more

28.09.23

How to Obtain Data on Populations Underrepresented in Clinical Trials

The FDA has published a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials”. The purpose of this document is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products in the postmarketing setting in typically under-represented patient populations in clinical trials.

more

28.09.23

EMA's Expectations for updated Investigator's Brochures and Informed Consent Forms

What are the expectations for distribution of updated Investigator's Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites / investigators?

more

28.09.23

GCP Inspection Reveals Deficiencies at CRO in India

Critical inspection findings at a study center in India led the European Medicines Agency (EMA) to launch a referral process and to review potential implications for marketing authorizations in Europe. This followed a GCP inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.

more

26.09.23

Ethylene and Diethylene Glycol Testing again in Focus of FDA Warning Letters

In recent months, the awareness for the impurities diethylene glycol (DEG) and ethylene glycol (EG) in pharmaceutical products was increased due to several FDA Warning Letters. We have reported on different examples where manufacturers failed to conduct proper identity testing of glycerin and other high-risk components. Now two more Warning Letters have been published, which also deal with this issue.

more

26.09.23

WHO issues draft Guidance on Best Practices for Clinical Trials

The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials.

more

26.09.23

New EMA Reflection Paper on the use of Artificial Intelligence

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

more

26.09.23

FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics