GMP News

Once again, the Questions & Answers documents with regard to centralised marketing authorisation procedures have been revised and published on the European Medicines Agency (EMA) website in June 2023. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

In June, the draft Certification Policy Document PA/PH/CEP(04) 1, 6R "Content of the dossier for CEP applications for chemical purity and microbiological quality of substances for pharmaceutical use" was published on the EDQM website for comments. Comments and remarks on this draft can be submitted until 15 September 2023.

The German draft bill on the controlled use of cannabis (German Cannabisgesetz - CanG) is available. Will cannabis now be removed from the German BtMG?

The EU is phasing out the extraordinary regulatory flexibilities for medicines that were put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. This includes regulatory procedures, manufacturing and importation of APIs and finished products and other requirements.

In June 2023, the U.S. FDA issued a Warning Letter to the Chinese company "Chengdu KeCheng Fine Chemicals Co., Ltd.". According to the Warning Letter, the company is registered within the USA as an API manufacturing facility, which shipped APIs to the U.S. several times.

The USP adopted the revised general chapter <670> Auxiliary Packaging Components. In particular a new category "odor adsorbent" has been added.

The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act". Comments can be submitted until 28 August 2023.

The FDA has updated one of its internal manuals to add a risk factor for facilities in countries where there has been an increase in violations. This is nothing more than a risk factor for a region or an entire country.

In the Pharmeuropa issue 35.3, a proposal for a revised chapter 2.2.47 "Capillary electrophoresis" was published. The deadline for submitting comments is 30 September 2023.

The complexity of therapeutic protein-based medicinal products makes characterisation of these products difficult. However, the use of artificial intelligence and machine learning in flow imaging microscopy opens up new possibilities.

The pharmaceutical industry's adoption of Quality Culture is transforming the way organisations approach quality management. Although challenges exist in fostering a culture of quality, the benefits outweigh the obstacles.

The EMA has updated its ICH M11 website to include overviews of comments received on the M11 draft documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template.