GMP News Drug Safety/Pharmacovigilance

16.12.21

Good Lay Summary Practice

The Clinical Trials Regulation (CTR) requires in Article 37 that the sponsor of a clinical trial must submit a lay summary. The European Commission has now published a guideline on "Good Lay Summary Practice" (GLSP).

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07.12.21

How to use Real-World Data for Benefit-Risk Assessment

The EMA and the FDA recently issued a guidance on the use of real-world data for benefit-risk assessment. What is required for registry-based studies?

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24.11.21

HMPC adopts revised Quality Guidelines for Herbal Medicinal Products

EMA´s HMPC adopted the revised Guidelines on Quality and Specifications for herbal substances, herbal preparations and herbal medicinal products. Will a written GACP declaration for the herbal substance now become a requirement? 

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09.11.21

Compassionate Use: EMA supports Submission of Medicinal Product Information

To support voluntary submissions of medicinal product information for medicinal products supplied in the EU / EEA via parallel importation, or for emergency and compassionate use, new 'Legal basis' values will be made available in the "Article 57 database" (xEVMPD).

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09.11.21

FDA issues Warning Letter for not complying with Clinical Trial Rules

The FDA issued a warning letter for not complying with regulations during the clinical investigation of a COVID-19- IMP. In particular, the sponsor failed to submit an investigational new drug application.

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09.11.21

FDA´s Q&As regarding Clinical Trials during the COVID-19 Pandemic

The FDA updated the Q&As concerning the conduct of clinical trials during the COVID-19 pandemic. The document provides general considerations to assist sponsors in assuring the safety of trial participants & maintaining GCP compliance. Amongst others the guidance deals with electronic signatures, remote monitoring and re-monitoring after pandemic-related restrictions are lifted.

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21.10.21

Safety Reporting - Responsibilities for Investigational Drugs and Devices

The FDA published a new draft guidance on the responsibilities regarding safety reporting for investigational drugs and devices. What is required for investigational device exemption studies?

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21.10.21

FDA Guidance on Benefit-Risk Assessment

The FDA has published guidance to clarify how considerations about benefit-risk assessment are integrated into the agency´s pre- and postmarket decisions for marketing applications. Read more about FDA´s draft guidance on Benefit-Risk Assessment for New Drug and Biological Products.

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21.10.21

New Limits for Heavy Metals in Food Supplements

The European Commission sets new limits for Cadmium and Lead in certain Foodstuffs and Food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a limited period of time.

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20.10.21

ANVISA List of approved Cannabis Products

The Brazilian Health Regulatory Agency (ANVISA) has published a list of cannabis products that will have automatic approval by the agency for individual importation by Brazilian patients. The list also includes a large number of CBD preparations.

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06.10.21

USP Chapter on Impurities in Food Supplements

USP´s Expert Committees for Non-Botanical & Botanical Dietary Supplements and Herbal Medicines propose the elaboration of a new USP general chapter <2760> on impurities in food supplements.

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05.10.21

FDA´s Q&As on Generic Drug Development during the COVID-19 Pandemic

What can be done when a test or reference product batch used in the conduct of a bioequivalence study expires while the study is interrupted due to the COVID-19 pandemic? Find out in FDA´s updated Q&As on Generic Drug Development.

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05.10.21

Clinical Trial Information System - EMA publishes Sponsor Handbook

The go-live date for the CTIS is 31 January 2022. The System will then become the single entry point for clinical trial application submission, authorization and supervision in the EU. In order to help sponsors prepare for using the CTIS, the EMA has now published a handbook.

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05.10.21

Updated Version of the Q&As regarding the Clinical Trials Regulation

The European Commission published a revised Version 4 of the Questions & Answers relating to the Clinical Trials Regulation. In particular, updates to Q&As in Chapter 11 "Arrangements for the transitional period" have been made.

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29.09.21

Serialization: Aide-Memoire for Pharmacies

The previously published Aide-Memoires for GDP and GMP Inspections regarding safety features are now accompanied by a third one: Aide-Memoire for Pharmacy Inspections. What are the obligations of persons authorized or entitled to supply medicinal products to the public?

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