Last week’s round-up, 09-13 September 2019

By Tessa Fiorini-Cohen and Marthese Mifsud

 

Stella Kyriakides has been named the new European Commissioner for Health

13 Sep 2019

Kyriakides will preside over the implementation of the EU Medical Devices Regulation and the In Vitro Diagnostics Regulation. Ursula von der Leyen has specifically requested that the new commissioner focuses on effective implementation of this new regulatory framework.

Other priorities that von der Leyen highlighted for the new commissioner are: ensuring supply of affordable medicines, maximising e-health potential, full implementation of the EU’s plan against antimicrobial resistance, myth-busting on vaccinations, and improvement of cancer prevention and care: http://bit.ly/RealGenerics-2kHMDZC

 

MHRA submissions portal to be used in case of no-deal Brexit

12 Sep 2019

The MHRA has updated guidance on its MHRA Submissions portal, which will need to be used if there is a no-deal Brexit.

The agency has recommended that the following groups register within the system so that they’ll be able to make submissions from day one if necessary: all pharmaceutical companies involved in medicines’ regulatory submissions and vigilance activities, clinical trial sponsors, e-cigarette producers, and brokers of medicinal products. Step-by-step guides have been published, explaining how to gain access to the portal and how to manage users within organisations: http://bit.ly/RealGenerics-2lIPzW9

 

BJP says sex should be considered as experimental variable in all studies submitted to it for publication

11 Sep 2019

Sex needs to be considered as an experimental variable in all future studies published in the British Journal of Pharmacology (BJP).

A recently published editorial explains this change in the journal’s author guidelines, citing the growing body of research on sex differences that affect pharmacology. Future studies published in the journal will need to either include both sexes in the experimental design, or provide a rationale why gender is not relevant to the experimental question. If only one sex is investigated, any conclusions will also need to be expressed cautiously, highlighting that findings from the work might not be replicable in the other sex. The editorial also offers advice on how to incorporate sex as a variable into an optimised experimental design: http://bit.ly/RealGenerics-2kuy6Re

 

Time for FDA to release complete response letters? Debate reignites

10 Sep 2019

The debate surrounding whether the FDA should start releasing Complete Response Letters has reignited.

When the FDA withholds approval for a drug, Complete Response Letters (CRLs) sent to the applicant indicate the reasons why and the additional data required for approval. The agency’s current regulations do not allow it to release these letters publicly, though it does allow applicants to do this. However, a recent study showed that related press releases issued by applicants only properly match 14% of these letters. The FDA’s former commissioner, Scott Gottlieb, explained that there are a number of reasons which have stopped the FDA from publishing these letters so far, including scarce resources and selectivity issues: http://bit.ly/RealGenerics-2m6MHm5

 

You don’t have to be old to be mature

09 Sep 2019

Quality maturity is a characteristic that the FDA would like to see in more pharmaceutical organisations.

Maturity can apply equally to start ups and more established organisations, and the FDA has offered specific advice on what makes a mature quality system. This includes the use of standardised tools for root cause analysis and standardised procedures for product and process transfers. Optimised set-up and cleaning procedures should be documented as best practice processes and rolled out throughout the entire plant. A large percentage of manufacturing equipment should also be under statistical process control, and all potential bottleneck machines should be identified and supplied with additional spare parts.

A supplier ranking system should be in place and customers’ requirements should be surveyed regularly. Manufacturers should also have joint improvement programs with suppliers to increase performance, and sites should have a clear focus that is closely linked to corporate objectives: http://bit.ly/RealGenerics-2lH6GYn

 

Image: Maturity Key, CC BY 2.0

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