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Last week’s round-up, 30 March – 03 April 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud

 

FDA Seeks Withdrawal of Heartburn Drugs Due to New Carcinogen Concerns

3 April 2020

The FDA has requested immediate withdrawal of all ranitidine products from the US market.

The carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in ranitidine products stored at higher temperatures, including those that products may be exposed to during distribution and handling by consumers. Levels of NDMA also increase over the shelf-life of products under normal storage conditions.

The immediate market withdrawal request means that ranitidine products will no longer be available for new or existing prescriptions or OTC use in the US. Ranitidine products will stay off the market unless a manufacturer can show that their particular product’s NDMA levels remain stable during storage.

https://bit.ly/RealGenerics-2X7IKxR

Report from the CMDh meeting held on 24-26 March 2020

2 April 2020

A report from the CMDh meeting held on 24-26th March 2020 has been published and includes information on the following:

  • COVID-19 outbreak and the impact on regulatory activities, including the impact on user testing of package leaflets.
  • A new Questions & Answers document on generic applications.
  • An update of the guidance document on the applicant’s response document in MRP and DCP for marketing authorisation applications.
  • An update of the Requirements on submissions (number and format) for New Marketing Authorisation Applications, Variations and Renewals within MRP and National Procedures.
  • Updates of the RMS and CMS validation checklists in MRP and DCP for human medicinal products.

Further information on the above, as well as other topics may be found in the following link: bit.ly/RealGenerics-3aBFqit

Maintaining control: Remote working and QP certification

1 April 2020

The MHRA Inspectorate has published an article on remote certification of batches by QPs, which is especially relevant in these days of remote working.

QP certification of pharmaceutical products is required to ensure that every batch released on the market has been manufactured and checked in compliance with the law, the requirements of the MA and GMP. This requires the regular presence of the QP at the manufacturing site.

Manufacturing sites may still operate when the QP is offsite and there is no regulatory requirement for the QP to be physically present to certify batches, provided the following aspects are adequately controlled:

  • The QP must be able to demonstrate that they are fulfilling their wider duties, through regular on-site visits and active participation in monitoring the quality system.
  • Any remote QP certification must be described and controlled within the pharmaceutical quality system. The technical agreements of contract QPs must provide for remote QP certification and should specify the frequency of QP attendance at the site.
  • The QP must have access to accurate and up-to-date information to support batch certification and release.

https://bit.ly/RealGenerics-2xIVGzy

CJEU to clarify criteria for SPCs on second medical use products

30 March 2020

The Court of Justice of the EU (CJEU) is set to provide guidance for the registration of supplementary protection certificates (SPCs) for new applications of a previously authorised medicinal product.

Article 3(d) of the SPC Regulation has raised several questions in national courts over the years, and the CJEU will be providing clarifications with respect to this Law. In particular, the interpretation of what constitutes a ‘different application’, when an SPC is provided for a ‘different application’ of a previously authorised medicinal product. It is not clear whether this refers to a second medical use of a product in humans and where the first use was as a veterinary product, or whether a new indication in a new therapeutic area, or new formulations, dosage regimen or modes of administration may also be considered as different applications. Further clarification has also been sought on the requirement that the different application must be “within the limits of the protection conferred by the basic patent”.

https://bit.ly/RealGenerics-2QVnsQk

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