Tower Mains Weekly Newsletter
Company Updates
After a successful 2022, we are looking forward to further expanding our expert team, building on our range of services, and increasing our footprint in 2023 and beyond. With this in mind, we are delighted to announce changes to our Executive team:
? Senior Associate Director, Rhona McAteer, has been promoted to Executive Director
? Head of QA, Shona Ross, has been promoted from Associate Director to Director
? Head of Operations, Lianne Roeling, has been promoted from Associate Director to Director
Tower Mains’ co-founders Dr Andrew and Fiona Waddell continue to be an integral part of the team; however, they will be taking oversight roles, allowing Rhona, Shona, and Lianne to look after the day-to-day running of activities.
Regulatory Updates
MHRA guidance updates
- On 26th January, the Medicines and Healthcare products Regulatory Agency (MHRA) uploaded PARs for Voltarol 140 mg Medicated Plaster, InVita D3 400IU soft capsules and InVita D3 800IU soft capsules to guidance on reclassifying a medicine. Click to view source
- On 30th January, information on IMFINZI was added to the guidance on Project Orbis, a programme to review and approve promising cancer drugs helping patients access treatments faster. Click to view source
- On 1st February, the MHRA published guidance detailing the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs). Click to view source
European Commission issues guide on the EU Clinical Trials Regulation
The European Commission issued a quick guide on the rules and procedures of the EU Clinical Trials Regulation (EU) No 536/2014, drawn up by the Clinical Trials Coordination and Advisory Group (CTAG).
CTIS becomes mandatory for new clinical trial applications in the EU
As of the 31st January 2023, all initial clinical trial applications in the EU must now be submitted via the Clinical Trials Information System (CTIS). This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on the 31st of January 2022. The authorisation and oversight of clinical trials is the responsibility of EU/EEA Member States while the EMA is responsible for maintaining CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.
MHRA publishes outcome of consultation on changes to statutory fees
On 31st January, the MHRA published the outcome of its consultation on the proposals for changes to the agency’s statutory fees. The agency reported a general acceptance of the need to ensure cost recovery for regulatory activities, and that this was important for ensuring a consistent level of service.
FDA issues considerations for the design and conduct of externally controlled clinical trials
On 1st February, the US Food and Drug Administration (FDA) published draft guidance providing recommendations to sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product.
Industry Updates
Ilona Reischl elected as new chair of EMA’s Committee for Advanced Therapies
On 26th January, the European Medicines Agency (EMA) announced its Committee for Advanced Therapies (CAT) has elected Ilona Reischl from the Austrian Medicines and Medical Devices Agency (AGES MEA) as its new Chair for a three-year mandate. Before becoming Chair, Dr Reischl served as Vice-Chair of the CAT for the last six years. She replaces Dr Martina Schüssler-Lenz, from the Paul-Ehrlich Institute (PEI) in Germany. The CAT will elect a new Vice-chair at its meeting on 16th of February 2023.
Emergency Use Authorisation of AstraZeneca’s Evusheld updated
On 26th January, AstraZeneca announced its Evusheld is not currently authorised for Emergency Use for pre-exposure prophylaxis of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralisation against. The FDA has notified AstraZeneca that it will decide on reinstating authorisation of Evusheld if the national prevalence of resistant variants decreases to 90% or less on a sustained basis.
FDA announces next presentation as part of its Grand Rounds lecture series
The FDA has released details on the next presentation as part of its Grand Rounds lecture series, which highlights a key public health challenge, and how the FDA is applying science and innovation to its regulatory activities. The next presentation, “A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids”, will take place at 12pm (ET) on the 9th of February 2023.
Federal court enters consent decree against Florida-based drug importer and distributor
From 30th January, the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against an importer and distributor of active pharmaceutical ingredients (API), used by the company’s customers to manufacture and/or compound finished drug products, and two of the company’s executives. Among other things, the consent decree requires ongoing compliance auditing and reporting to the FDA and provides that the FDA may take appropriate action in the event the defendants further violate the FD&C Act.
Warning letters issued to five companies illegally selling products for treating or preventing mpox
From 31st January, the FDA issued warning letters to five companies illegally selling products that claim to cure, treat, mitigate, or prevent human monkeypox (mpox) infection. There are no FDA-approved treatments for mpox, and these products, which are often sold online, have not been reviewed by the FDA or proven to be safe and effective to treat mpox or other diseases or conditions.
FDA approves first oral treatment for anaemia caused by chronic kidney disease for adults on dialysis
From 1st February, the FDA approved Jesduvroq tablets as the first oral treatment for anaemia caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis. Other FDA-approved treatments for this condition are injected into the blood or under the skin.
European Commission publishes materials from its Biosimilar Medicines stakeholder event in December
The European Commission has published video recordings and presentations from the Biosimilar medicines stakeholder event held on the 13th of December 2022. This includes presentations on improving biosimilar access to the benefit of patients, the available evidence on interchangeability of biosimilars and national biosimilar policies.
Issue Number: WN00097
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