Last week’s round-up, 23-27 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


EMA advises companies on steps to take to avoid nitrosamines in human medicines

27 Sep 2019

All EU marketing authorisation holders of medicinal products containing chemically synthesized APIs need to review their medicines for the possible presence of nitrosamines within the next six months.

The EMA is sending a notice to this effect to all MAHs detailing the steps that need to be taken. The EMA expects companies to prioritise evaluations, starting with medicines more likely to be at risk, and taking into account findings from the CHMP’s review of sartans. MAHs should inform the concerned competent authorities when the risk evaluation is concluded – the related documents do not need to be submitted but should be made available upon request.

Products at risk of containing any nitrosamines need to be tested, and any detection of nitrosamines needs to be immediately reported to authorities. Following this, any necessary changes to marketing authorisations will need to be applied for. The EMA expects that companies complete these follow-on steps within 3 years for products for which a risk is identified. A Q&A document to guide MAHs has been released:


EMA Offers Edits on FDA Draft Guidance on Biosimilars

26 Sep 2019

The EMA has offered line-by-line comments and edits on the FDA’s draft guidance on comparative analytical assessments for biosimilars. It’s quite a rare move for one regulator to offer public feedback on another regulator’s drafts, and the EMA explained that they provided this to continue their previous exchange of thoughts on the topic with the FDA. The comments include questions for clarification, recommendations to omit certain text, and notes on areas of commonality. The EMA has also pointed out aspects which it considers very important elements and fully supports. The draft guidance revises a guidance finalised in 2015 on quality considerations for demonstrating biosimilarity, and replaces the 2017 draft guidance on statistical approaches to evaluating biosimilarity. A number of stakeholders have also commented on the draft, including the American Association of Pharmaceutical Scientists, the Association for Accessible Medicines and various pharmaceutical companies:


FDA Issues 53 Product-Specific Guidances

25 Sep 2019

The FDA has released 53 product-specific guidance documents to aid generic drug development.

These include 34 new guidance documents, 26 guidances for treatments that currently lack generic competition and 16 for complex products. Mesalamine, armodafinil, and budesonide are among the active substances for which revised draft guidances have been released, whereas new documents include guidance for ibrutinib, tecovirimat, duvelisib and baricitinib:


Updates on nitrosamine impurities in pharmaceuticals

24 Sep 2019

Ranitidine medicines have been shown to contain the carcinogenic impurity N-nitrosodimethylamine (NDMA).

This is the same impurity previously found in sartan-containing medicines, and the EMA and FDA are reviewing all ranitidine medicines after tests showed that some contained the impurity. Singapore’s Health Sciences Authority has stopped the sale of eight products containing ranitidine, and Novartis and Dr. Reddy’s have announced that they’re halting distribution of their versions of the drug in all markets. The EDQM has also stated that it is working with the EMA, national competent authorities and international partners on the issue.

So far, nitrosamines have been found in batches of sartans, pioglitazone, and ranitidine, Thus, the EMA will be providing guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. Executive Director, Guido Rasi has stated that “It is of paramount importance that we learn from our experience with sartans and take a proactive approach for other classes of medicines.”

We’ve collated all related updates on ranitidine and NDMA here:


Europe’s potential for biotech innovation

23 Sep 19

Europe lags behind both China and the US in patents for new biotech medicines.

This contrasts with the number of life-sciences publications per region, with Europe leading the pack in this case. Contributing to this difference is the fact that Europe’s biotech companies only receive about 20% of the funding that US companies do. This information is further detailed in the following infographic:

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