Tower Mains Weekly Newsletter

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Industry Updates

FDA publishes a series of guidances under Drug Competition Action Plan

On 26th January, the US Food and Drug Administration (FDA) published a series of guidances focused on generic drug application submissions, labelling, and review. These guidances support FDA’s Drug Competition Action Plan (DCAP), which encourages robust and timely market competition for generic drugs. Offering clarified, up-to-date guidance for industry demonstrates FDA’s commitment to bringing more high-quality, safe, effective, and affordable generic medicines to all consumers. These guidances include:

Information Requests and Discipline Review Letters Under GDUFA Final Guidance

Revising ANDA Labelling Following Revision of the RLD Labelling Revised Draft Guidance

Good ANDA Submission Practices Final Guidance

MHRA publishes guidance on implementing adequate oversight and monitoring investigational medical product trials

On 28th January, the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance to assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.

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MHRA publishes guidance on a risk-adapted approach to clinical trials in the UK

On 28th January, the MHRA implemented a dual strategy for a risk-adapted approach to clinical trials in the UK. The first part of the strategy is the stratification of trials into type A, B, or C depending upon the use of the investigational medicinal product (IMP) in relation to its marketing authorisation or an unlicensed IMP. This will impact the MHRA authorisation process, indicate potential changes to trial documentation requirements and inform the safety monitoring plan. The second part is a trial-specific risk assessment to identify specific vulnerabilities in the trial conduct that could impact the trial results and the protection of trial participants’ safety, rights, and wellbeing. This would document the mitigations for specific identified risks and any adaptations from traditional GCP. These would then be developed such that there would be risk proportionate management and monitoring of the trial.

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ICH E9(R1) training material published on ICH website

On 28th January, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the training material for its ICH E9(R1) Estimands and Sensitivity Analysis in Clinical Trials.

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Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) becomes applicable

On 28th January, the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) became applicable. The new Regulation contains measures that will simplify regulatory processes, striving to reduce the administrative burden for current marketing authorisation holders and developers of new and innovative veterinary medicines to further encourage medicine innovation and development.

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EMA issues highlights from its latest CHMP meeting

On 28th January, the EMA issued highlights from its human medicines committee (CHMP) held on the 24th-27th January 2022. Highlights include the recommendation of seven medicines, updated CHMP statistics, and withdrawn marketing applications.

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EMA starts a review concerning the conduct of studies at Synchron Research Services, India

On 28th January, the EMA announced it has started a review of medicines for which studies have been conducted by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India. This follows a GCP inspection and analyses of study data carried out by the FDA, which in September 2021 led the FDA to reject all studies conducted at the CRO.

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Regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices published

On 31st January, the regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. The new regulation enters into force on the day following this publication and becomes applicable as of the 1st of March 2022, except for the provisions on shortages of critical medical devices which will apply as of the 2nd of February 2023. It puts structures and processes established by EMA during the COVID-19 pandemic on a permanent footing while entrusting several new tasks to the agency. Under its extended mandate, EMA will facilitate a coordinated EU-level response to public health emergencies and will set up, maintain, and manage, by early 2025, a European Shortages Monitoring Platform to facilitate data collection and reporting by companies and the Member States on shortages, supply, and demand of critical medicines.

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FDA to hold Advisory Committee Meeting to discuss the request for EUA of Pfizer-BioNTech COVID-19 vaccine for use in infants

On 1st February, the FDA announced that it is holding a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 15th February 2022 to discuss the request for emergency use authorisation of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age. The FDA authorised the Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age in October 2021 and recently authorised the use of a single booster dose in individuals 12 through 15 years of age and older. The FDA intends to live-stream the meeting on the agency’s YouTube channel, and it will also be webcast from the FDA website.

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MHRA launches 8-week consultation on new Clinical Trials Legislation

On 1st February, the MHRA launched an 8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit from the European Union, the Medicines and Medical Devices Act has given the MHRA the opportunity to update its current legislation in relation to clinical trials. The new proposals are based on feedback from stakeholders and an Expert Working Group, which included representatives from academia, industry, and patient groups. The agency is seeking the views of clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals, and the wider public to help shape improvements to the legislation. The consultation will close at 11pm on Monday, 14th March 2022.

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Issue Number: WN00046

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