GMP News - Pharmaceutical Development / Clinical Trials / GCP

21.09.22

Examples of Analytical Method Implementation

Following the recently introduced new Ph. Eur. chapter 5.26 Implementation of pharmacopoeial procedures, the EDQM published some examples to provide users with practical guidance. How can the critical factors potentially affecting the analytical procedure performance be identified?

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20.09.22

How to Submit Documents with Real-World Data to FDA

To facilitate FDA’s internal tracking of submissions that include real-world data (RWD), the agency published a guidance on how to identify the use of RWD in submission cover letters.

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20.09.22

Charging for IMPs? FDA has some Answers

The FDA issued a revised Q&A document on charging for investigational medicinal products (IMPs). The draft guidance responds to frequently asked questions about FDA's processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances.  

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20.09.22

FDA publishes Answers to GCP Questions

The FDA addresses inquiries from stakeholders related to Good Clinical Practice on an ongoing basis and has now published responses to questions received from 2017 to 2021. One of the interesting questions asks: Is it possible to have a Remote Location ("satellite site")?

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20.09.22

Labeling Requirements for IMPs Amended

The European Commission finally adopted the revised Annex VI to the CTR as regards labelling requirements for IMPs. The amendment eliminates the obligation to include an expiry date on the primary packaging of IMPs in specific circumstances.

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14.09.22

ANVISA´s Q&A on Medical Cannabis for Clinical Investigations

The Brazilian Health Regulatory Agency, ANVISA, published answers to questions received during a webinar on clinical research with medicinal Cannabis held in May this year. One of the important questions addressed is: How can batch reproducibility be demonstrated?

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13.09.22

UK changes SUSAR Reporting for IMPs

The eSUSAR website used for the submission of SUSAR reports to the MHRA will be decommissioned at the end of September and only SUSARs via the ICSR Submissions portal will then be accepted.

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07.09.22

EMA Publishes Comments Received on ICH Q2(R2) and Q14

In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation. End of August, an overview of the comments received was provided.

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31.08.22

USP Article: In Vitro Test Methods for Continuous Manufacturing

The continuous manufacture of medicinal products is a young, spreading type of modern pharmaceutical production. In contrast to classical batch manufacturing, these processes run continuously, i. e. dosing and product withdrawal run uninterrupted and are continuously monitored. A recent USP article discusses what release testing might look like.

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24.08.22

China GMP: New Annex 13 for IMPs

In May, the Chinese National Medical Products Administration (NMPA) published their new Annex 13 "GMP for Investigational Medicinal Products (IMPs)", which was incorporated into the Chinese GMP guidelines on July 01, 2022.

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16.08.22

CTIS & EudraVigilance - Update for Sponsors of Clinical Trials

The EMA provides guidance for sponsors who have to report SUSARs via EudraVigilance originated in the context of clinical trials. In addition the updated document "Key Information for Sponsors on CTIS" has been published.

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16.08.22

FDA offers "Snapshot" Feature for Clinical and Development Guidelines

Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?

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27.07.22

Extended Input Deadline for USP´s new Chapter on Quality Considerations for Cannabis

Following the previously announced elaboration of a new USP chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research the input deadline has been extended.

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30.06.22

FDA´s new Guidance on Readability

The FDA published a new guidance on the readability of container labels and carton labeling design. What is the recommended font size?

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30.06.22

Benefit-Risk Assessment for Product Quality Evaluation

Before approving an application, the FDA must determine whether the drug product is both safe and effective for use. A new draft guidance describes the FDA principles when conducting product quality-related assessments of CMC information.

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