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Grant Castle

Grant Castle is a partner in London, Brussels, and Dublin practicing in the areas of EU, UK, and Irish life sciences regulatory law. He supports innovative pharmaceutical, biotech, medical device and diagnostics manufacturers on regulatory, compliance, legislative, policy, market access and public law litigation matters in the EU, UK, and Irish Courts.

He is one of the Co-chairs of Covington's Life Sciences Industry Group and is Head of Covington's European Life Sciences Regulatory Practice.

Grant regularly advises on:

EU and UK regulatory pathways to market for pharmaceuticals and medical devices, including in vitro diagnostics and on associated product life cycle management;
Pharmaceutical GxPs, including those governing pharmacovigilance, manufacturing, the supply chain and both clinical and non-clinical research;
Medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
Advertising and promotion of both pharmaceuticals and medical devices; and
Pricing, reimbursement and market access for both pharmaceuticals and medical devices.

Grant also handles procedural matters before EU, UK and Irish regulators and UK and Irish market access bodies, where necessary bringing judicial reviews for his life sciences clients before the EU, UK and Irish Courts.

Chambers UK has ranked Grant in Band 1 for Life Sciences Regulatory for the last 21 years. He is recognized by Chambers UK, Life Sciences as "excellent," "a knowledgeable lawyer with a strong presence in the industry," who provides "absolutely first-rate regulatory advice," according to sources, who also describe him as "one of the key players in that area,” whilst Chambers Global sources report that "he worked in the sector for many years, and has a thorough understanding of how the industry ticks." He is praised by clients for his "absolutely first-rate" European regulatory practice. Legal 500 UK notes that he is "highly competent in understanding legal and technical biological issues."

Contact:Read more about Grant CastleEmail
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The UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) is seeking industry feedback on its new draft guideline on individual messenger ribonucleic acid (“mRNA”) cancer immunotherapies (the “Draft Guidance”).  Building on the success of mRNA vaccine technology in response to the Covid-19 pandemic, the technology is now being adapted to target diseases such as cancer.  The MHRA aims to provide a streamlined robust regulatory framework for the approval of such personalised mRNA-based cancer vaccines without compromising safety.

The Draft Guidance covers the regulatory classification of these novel cancer treatments, product design and manufacture, non-clinical and clinical development, pharmacovigilance and the distribution of information to the wider public.  Notably, the MHRA explicitly acknowledges that the regulatory and scientific principles discussed in the Draft Guidance could broadly apply to other disease indications or technologies that could benefit from personalisation or individualisation.  Therefore, industry should be aware that the scope of the Draft Guidance may be extended in the future beyond mRNA cancer immunotherapies that use lipid nanoparticle delivery systems to other delivery systems and disease areas.  Manufacturers, developers, patient organisations and other stakeholders have until 31 March 2025 to comment on the Draft Guidance.

We explore some of the interesting regulatory considerations arising from the Draft Guidance below.

Regulatory Classification

The classification of a medicinal product is key to determining what requirements and guidelines apply to the development, manufacture and delivery of that product.  For example, advanced therapy medicinal products (“ATMPs”) have specific Good Manufacturing Practice (“GMP”) requirements (see e.g., ‘Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products’), strict traceability requirements and additional pharmacovigilance requirements.

Currently, individual mRNA cancer immunotherapies are classified under the Human Medicines Regulations 2012 (as amended) (“HMRs”) as ATMPs and are sub-classified as gene therapies.  However, current mRNA therapies do not fit neatly under the ‘gene therapy’ umbrella because, unlike conventional gene therapies, which are designed to edit a person’s genome to treat or cure a disease, mRNA therapies do not involve integration into the host genome.

The Draft Guidance reveals that “a new ATMP sub-classification for nucleic acids that do not edit the patient’s genome is being considered.”  A practical advantage of a new sub-classification would be the opportunity to create bespoke and risk proportionate requirements and guidelines for mRNA therapies.  This would avoid overburdensome risk mitigations for these products as compared to similar products such as COVID-19 vaccines.

The Draft Guidance also predicts that mRNA therapies could be chemically synthesised (i.e., not manufactured by biotechnology).  Such therapies would fall outside the scope of the current definition of a gene therapy as they would not be a biological product.  The MHRA is considering the classification of relevant chemically synthesised mRNA therapies as ATMPs.Continue Reading MHRA Consultation on Individualised mRNA Cancer Immunotherapies – Unique opportunity for a streamlined risk based regulatory framework?

On 23 January 2025, we hosted the 2025 edition of the Covington European Life Sciences Symposium. The Symposium brought together colleagues from London, Brussels, Frankfurt and Dublin with our industry connections to explore the evolving challenges and opportunities facing the European life sciences sector.

Throughout the day our speakers shared their perspectives on a range of legal, regulatory, and business trends, including the evolving regulatory frameworks in the EU and UK; information exchange in ongoing collaboration; investigations and whistleblowing; key ESG topics, and the complexity of options to acquire in pharma deals.

We have set out some of the discussion from the sessions below.

European Life Sciences – The Changing Landscape for Pharma and Biotech

Grant Castle, Head of Covington’s European Life Sciences Regulatory Practice, Peter Bogaert, Marie Doyle-Rossie and Anna Wawrzyniak kicked off with a discussion about the Changing Landscape for Pharma and Biotech.

The UK and EU both aim to deliver access to innovative and transformative medicines and foster international competitiveness in the life sciences industry. Despite the practical challenges faced by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in recent years, it has emerged as an ambitious regulator and is establishing innovative regulatory frameworks, including an international reliance scheme (see our update here), point of care manufacturing regulations, and the relaunch of the Innovative Licensing and Access Pathway (ILAP).

The EU is also pursuing a wave of legislative reform, including wide ranging revisions to the EU’s pharmaceutical legislation, the EU’s supplementary protection certificates (SPC) rules, and proposals for a compulsory licensing scheme.

There can sometimes be a tension between the UK’s and EU’s aims and the practical impacts of regulatory reform, especially in the early stages of implementation.Continue Reading The Covington European Life Sciences Symposium 2025

The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications, or where the MAA results in a negative opinion or is otherwise withdrawn.  These expanded activities are due to apply for MAAs submitted from April 2025 onwards.

The EMA originally implemented its CDP Policy in October 2016.  The policy provides a proactive obligation on the EMA to publish clinical data submitted to the agency under any MAA submitted via the EU centralized procedure.  However, the EMA has faced challenges during implementation of the policy due to operational constraints.  The CDP Policy therefore currently only applies to the following centralized procedures:

  • applications for COVID-19 medicines; and
  • initial MAAs for new active substances that receive a positive or negative opinion from the Committee for Medicinal Products for Human Use (CHMP), or which are withdrawn.

The latest announcement from the EMA means that line extensions and applications for major clinical Type II variations (such as the extension of indications) will similarly be subject to the CDP Policy from April 2025.  However, biosimilar, hybrid and generic MAAs are still excluded from the scope of the CDP Policy.  These types of applications usually include limited clinical data, and the EMA had observed that these data sets were infrequently accessed by the public when previously made available under the CDP Policy.

What clinical data is subject to the CDP Policy?

The CDP Policy applies to the following categories of data submitted with a centralized procedure MAA:

  • the clinical overview, which provides a critical analysis of the clinical data in the submission package, including the conclusions and implications of the clinical data;
  • the clinical summary, which provides a detailed factual summarization of all the clinical information submitted;
  • the study reports for the individual clinical studies; and
  • three appendices to the clinical study reports, namely the study protocol, the sample case report form used to record information on an individual patient, and documentation of the statistical methods used to analyze the data.

Continue Reading EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to harmonize the regulatory landscape across the continent in order to improve access to quality, safe and efficacious medical products in Africa. Other key organizations who are working to establish and implement the vision set out for AMA include the African Union (AU), comprising of 55 member states in Africa, the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO). Of importance, AMA is expected to play an important role in facilitating intra-regional trade for pharmaceuticals in the context of the Africa Continental Free Trade Area (AfCFTA).

Background to AMA and medicines regulation in Africa

Africa currently has limited harmonization of medicines regulation between jurisdictions. The functionality and regulatory capacity of national medicines regulatory authorities varies significantly. For example, many national regulators lack the technical expertise to independently assess innovative marketing authorization applications and instead adopt “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. Pharmaceutical manufacturers seeking to conduct multinational clinical trials or launch their products across Africa can often face challenges when navigating the divergent requirements for each country (and can face additional delays during each approval process).

Multiple initiatives in the last decade have aimed to increase the harmonization of medicines regulation across Africa with varying degrees of success, such as:Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines Agency