Photo of Roderick Dirkzwager

Roderick Dirkzwager

Roderick Dirkzwager advises clients in the life sciences sector on a broad range of regulatory, transactional and intellectual property matters relating to the discovery, development and commercialization of their products.

Roderick is a member of Covington’s Diversity and Inclusion Committee and is a co-lead of the LGBT+ Affinity Group in London.

With a broad life sciences practice, Roderick regularly advises on:

  • EU, Irish, and UK regulatory issues relating to pharmaceutical products and medical devices;
  • commercial agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, distribution arrangements and manufacturing and supply contracts;
  • regulatory and commercial due diligence for life sciences transactions; and
  • intellectual property issues arising in corporate transactions and IP-related contracts.

Roderick is also a member of Covington's Life Sciences in Africa team and advises clients on regulatory and commercial strategies for the supply of medical products across Africa, including through international recognition procedures such as WHO pre-qualification. Prior to joining the firm, Roderick completed his Ph.D. in Biochemistry, focusing on the development of novel, low-cost malaria diagnostic technologies using DNA aptamers.

Contact:Read more about Roderick DirkzwagerEmail

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any applications for line extensions or new indications, or where the MAA results in a negative opinion or is otherwise withdrawn.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