GMP News - Pharmaceutical Development / Clinical Trials / GCP

09.06.21

US Implementation of ICH Q12

The US FDA recently issued a draft guidance to help manufacturers implement ICH Q12 by explaining how to submit ECs. In addition, the agency provides general guidance about the elements that are considered ECs for the device constituent part of combination products.

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19.05.21

ICH E6 GCP Guideline: Updated GMP for IMP Principles

The ICH has published a draft version of the updated principles that are currently under development by the ICH E6(R3) EWG. Amongst others, the updated version includes revised and expanded principles regarding GMP for IMPs. 

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18.05.21

What are the requirements for an eCRF?

What is an eCRF? The MHRA GCP Inspectorate recently informed about the requirements for eCRFs (electronic case report forms). In addition they listed several findings from current GCP inspections.

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12.05.21

New Version of WHO Guidelines on Process Transfer Published as a Draft

The WHO has recently published a new version of its guidelines on the transfer of technology as a draft. Many new chapters have been added to the previous document.

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06.05.21

GMP for Advanced Therapies (ATMP) - Many Questions and some Answers

With the development of more and more guidance documents in the field of ATMP, new questions arise. The EMA has therefore published a Q&As paper on the GMP requirements for ATMPs.

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06.05.21

Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products

In order to take account of the rapid development in the field of biological medicinal products and ATMPs, the PIC/S has revised Annex 2 of its GMP Guideline and made it available for comment.

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28.04.21

EMA confirms full functionality of CTIS - on track to go live January 2022

Last week, the EMA confirmed that the clinical trial EU Portal and Database (Clinical Trial Information System (CTIS)) is now fully functional and on track to go live by 31 January 2022.

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30.03.21

Post-Authorization Safety Studies - Recent Inspection Findings

The MHRA recently published inspection findings in the conduct of post-authorization safety studies (PASS). In particular, the agency observed significant breaches of the study protocol for the MAHs non-interventional PASS during inspection at a study site.

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30.03.21

How to Classify Changes to Ongoing Clinical Trials

The European Commission published an updated Version 3 of the Questions & Answers relating to the Clinical Trials Regulation. Amongst others, the new version covers the classification of changes to ongoing clinical trials.

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30.03.21

Reference Safety Information in Clinical Trials

The MHRA GCP inspectorate has continued to see non-compliance in reference safety information in clinical trials. In particular, the agency is still seeing unreported SUSARs and absence of adequate risk mitigation measures due to incorrect use of the RSI.

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23.03.21

Pharmacovigilance Inspection Metrics

The MHRA GVP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020. The highest number of all findings in the reporting period related to risk management followed by quality management systems.

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11.03.21

New FDA Guidance for COVID-19 Packaging Changes: Glass Vials and Stoppers

COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. Therefore, the FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of postapproval change submissions.

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11.03.21

COVID-19 Vaccines, Tests and Therapeutics - Recommendations for Handling Emerging Virus Variants

The new variants of SARS-CoV-2 are now occupying the minds of scientists around the world. The FDA is responding with a series of updated guidelines and recommendations for developers and manufacturers of vaccine tests and therapeutics.

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04.03.21

EMA Guidance on Adjusting Vaccines to COVID-19 Variants

Authorisation requirements for adjusted COVID-19 vaccines: the EMA publishes recommendations for vaccine developers and manufacturers.

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03.03.21

How to Characterize Viscoelastic Properties of Semisolids

The USP General Chapters - Physical Analysis Expert Committee revised the general chapter <1912> Measurement of Hardness of Semisolids. Amongst others, a definition for "yield stress" has been added.

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