GMP News - Regulatory Affairs

08.01.20

Ph. Eur. Draft Chapter for PA Contaminants in Herbal Drugs

A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of  Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.

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04.12.19

FDA continues to warn companies for illegally selling CBD products

The FDA recently issued 15 warning letters to companies for illegally selling products containing cannabidiol (CBD).

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04.12.19

ICH Q12 adopted

The new ICH Q12 Guideline for Post-Appproval Changes has been adopted in Singapore in November 2019. The document provides guidance on a framework to facilitate the management of post-approval CMC changes.

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13.11.19

FDA works on regulatory pathways for CBD products

Cannabidiol (CBD) is currently marketed in a variety of product types, such as oil drops, infused pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the FDA is working on the evaluation of regulatory policies related to cannabis and cannabis-derived ingredients.

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24.10.19

How to find the key to Ph. Eur. Monographs?

The Ph. Eur. provided a sample monograph to clearly show which information is included in and how to work with a Ph. Eur. monograph.

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09.10.19

How to get GMP Certificates, Importation Licenses & Broker Registrations in UK?

The MHRA recently provided details for new licence applications and variations on the agency´s Inspectorate Blog - together with some helpful links.

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08.10.19

Evaluation of the Immunogenicity of Therapeutic Protein Products - FDA Scientists developed a new Tool

For the important assessment of possible immune responses to therapeutic protein drugs, FDA scientists developed a new mathematical tool to calculate the expected risk of producing antibodies against the biological drug.

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08.10.19

ATMP from Third Countries - New Q&A Paper on Batch Release published

With a new Q&A document, the EMA has provided information on the release of Adavanved Therapy Medicinal Products (ATMP)  imported into the EU by the Qualified Person without batch re-testing.

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26.09.19

EDQM updates two Guidelines on the CEP procedure

The updating of two important documents by the EDQM reflects the current practice of the CEP procedure. Read more about the competencies and responsibilities of the various bodies in the CEP application procedure and about the code of practice for assessors and inspectors.

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26.09.19

Official Danish Cannabis-Monograph

Denmark has published its official pharmacopoeial monograph for Cannabis: Cannabisblomst (Cannabis flos).

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18.09.19

New FDA guidance on Child-Resistant Packaging

The FDA published a new guidance on Child-Resistant Packaging (CRP). The guidance is intended to assist applicants, manufacturers, packagers, and distributors who include CRP statements in their drug product labeling.

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04.09.19

USP Packaging Standards

The USP´s General Chapters—Packaging and Distribution Expert Committee provided an overview of USP´s current packaging standards-strategy in the curent issue of Pharmacopeial Forum. The stimuli article covers USP general chapters related to the suitability for use for materials of construction including plastics and elastomers.

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07.08.19

FDA's promotion for cell and tissue products - the TRG Rapid Inquiry Program (TRIP)

With an additional program to support manufacturers of cells, tissues and cell-based products, the FDA is trying to accelerate its promotion of the development of regenerative therapies.

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31.07.19

Brexit: Industry should keep Timelines for Batch Testing Facilities

The EMA points out that - independent from the Brexit postponement - MAHs should use the remaining time to complete all necessary preparations.

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31.07.19

EMA publishes Draft on Quality Requirements for Combination Products

The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?

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