Last week’s round-up, 27-31 January 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


Nitrosamine contamination: new web page on EDQM response

31 January 2020

The EDQM website now contains a web page providing centralised access to all information related to nitrosamine contamination.

This resource page is regularly updated and contains general information as well as details on actions taken to address the issue, including related updates to the European Pharmacopoeia and Certificates of Suitability. The EDQM web page also contains a section on the analytical methods developed by the network of Official Medicines Control Laboratories in order to adequately control the levels of nitrosamines in the medicines concerned.


The new Pharmeuropa website is now online

30 January 2020

EDQM has redesigned the platform to include new features, including improved search query management and improved navigation when using standard web browsers, tablets and smartphones. A notification tool now enables users to set alerts based on particular monograph numbers or Ph. Eur. groups of experts.

All users will have to register for access, and EDQM has released a related user manual:


Monograph on Rosuvastatin tablets (3008) published in Ph. Eur. Supplement 10.1

29 January 2020

A new monograph on Rosuvastatin tablets (3008) has been published in Supplement 10.1 of the European Pharmacopoeia (Ph.Eur.), and will become effective on 1st April 2020.

This is the first monograph on a multi-source medicinal product to have been adopted by the Ph. Eur. Commission. Further information on how to read and apply the monograph may be found in the document “General principles for Monographs on Finished Products (FPs) containing chemically defined active substance”, which is available on the EDQM website.

Further monographs are expected as a group of experts will be working on other monographs on multi-sourced products and their corresponding APIs in 2020.


House Committee Quizzes FDA on Complex Generic Drugs

28 January 2020

A bipartisan group of congress representatives have quizzed the FDA on its efforts to speed up the approval of complex generic drugs.

In their letter to the FDA, the representatives pointed to lengthy approval times for recently approved complex generics. They have asked the FDA to provide them with a list of all complex generic drugs approved since October 2016, copies of any after-action reports or related internal reviews, and a list of product-specific guidances that the FDA has published for such drugs. The representatives have also requested information on the number of pre-Abbreviated New Drug Application (ANDA) meetings and product development meetings for such products, both requested and held:


EU Regulatory Roundup

27 January 2020

The UK government has not accepted an amendment to Brexit legislation, proposed by members of the House of Lords, to “take all necessary steps” to remain in the European medicines regulatory network i.e. continued involvement in EMA activities. Other related amendments were also proposed but none of these have passed. This has raised concerns that unless there is alignment between the UK and EU regulatory processes, patients in the UK will face delays in accessing new medicines after Brexit.

Among other topics discussed in the linked roundup article include: a cybersecurity threat at the Dutch Medicines Evaluation Board (MEB), a pharmacovigilance questionnaire distributed to companies in Germany by the Federal Institute for Drugs and Medical Devices (BfArM), and the disruption of operations of the Finnish Medicines Agency (Fimea) due to its relocation.


Image: Victoria Tower, Palace of Westminster, CC BY 2.0

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