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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 18 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."

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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