Heartburn by Flickr user Christopher Dart

Last week’s round-up, 06-10 January 2020

By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud


Decentralised Procedure – Requests to act as RMS

10 January 2020

National competent authority instructions for DCP RMS slot requests have been updated: http://bit.ly/RealGenerics-2NgpZTs


The Decade In Global Health: New Drugs, Faster Trials, Social Media To The Rescue

09 January 2020

When it comes to global health, most significant medical advances occur in high-income countries and only become available in lower-income countries several years down the line or not at all. However, over the past decade several medical breakthroughs have gone on to have a global reach.

This article highlights some of these breakthroughs, which have gone on to save millions of lives around the world. The medical advances discussed include the development of Dolutegravir, a new drug that has been successfully used to treat HIV, and the development of Bedaquiline and Delaminid which have been used to treat drug-resistant tuberculosis. Another breakthrough includes the speeding up of clinical trials, brought on by the outbreak of Ebola in West Africa, in which new promising drugs passed through clinical trials in just over two years. Other advances include the use of digital media to track outbreaks and spread of disease, a new Meningitis A vaccine that has saved millions of lives across the African continent, and a campaign to provide Kenyan children access to deworming medication, successfully preventing malnutrition caused by intestinal worms.



Lab finds NDMA in Zantac can develop during storage

08 January 2020

The nitrosamine impurity NDMA can form in ranitidine tablets during shelf-life.

Emery Pharma, an independent laboratory in California, has filed a Citizen Petition requesting that the FDA recall all ranitidine-containing medicines from the US due to possible contamination with the carcinogen NDMA following exposure to high temperatures, even after they have been packaged and released on the market. According to the petition “preliminary data indicate that NDMA accumulates in ranitidine-containing drug products on exposure to elevated temperatures, which would be routinely reached during shipment and during storage. More importantly, these conditions occur post-lot release by the manufacturer.

Hence, while NDMA levels in ranitidine may be acceptable at the source, they may not be so when the drug is purchased and subsequently at the time of consumption by the consumer.”

Further details may be found in the following article: http://bit.ly/RealGenerics-2N8phaN


Information on texts harmonised by the PDG

07 January 2020

The 10th edition of the European Pharmacopoeia has now entered into force, bringing with it changes in the location of information provided on pharmacopoeial harmonisation.

The harmonisation status of general texts and excipient monographs is now available in two comprehensive tables on the EDQM website, instead of in general chapter 5.8 on pharmacopoeial harmonisation. To date, 30 of the 31 general chapters and 46 of the 60 excipient monographs on the current Pharmacopieal Discussion Group work programme have been harmonised: http://bit.ly/RealGenerics-2uqKMx0


Meeting E&L Expectations

06 January 2020

Extractables and leachables (E&L) testing is required in drug product MA submissions in order to determine whether any potentially harmful compounds found in the packaging, delivery systems or manufacturing surfaces can contaminate the drug product.

Despite the importance of E&L testing and increasing stringency of regulators, the regulatory guidance available does not detail how this testing should be implemented. This may result in delays or even rejections of MA submissions due to incomplete or insufficient E&L testing.

Challenges have especially been encountered with biologics, as these ‘large-molecule drug substances pose greater risks of interacting with the packaging, delivery system, or manufacturing surface’. Biologics are also typically developed as parenteral formulations with single-use systems such as disposable plastics and bags, which increase the risk for E&L.  This article reviews the importance of meeting E&L expectations and related challenges faced by industry: http://bit.ly/RealGenerics-36uZL70


Image: Heartburn, CC BY 2.0

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