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Robin Blaney

Robin Blaney is a partner in the firm’s Life Sciences practice.  He advises pharmaceutical, biotechnology, medical device and cosmetic manufacturers and trade associations on a wide range of regulatory, compliance, transactional and legislative matters, as well as the full range of commercial agreements that span the product life-cycle in the life sciences sector.  His expertise includes clinical trial agreements, manufacturing and supply agreements, distribution and other marketing agreements, regulatory services agreements, and tenders.  He has particular experience structuring and documenting EU pharmaceutical distribution arrangements and transitional arrangements relating to product acquisitions.  Robin writes and speaks regularly on subjects such as medical device regulation, pharmacovigilance and clinical trials.

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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any applications for line extensions or new indications, or where the MAA results in a negative opinion or is otherwise withdrawn.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receive a positive or negative opinion from the Committee for Medicinal Products for Human Use (CHMP), or which are withdrawn.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

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“theProposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages.  In particular, there are new obligations for Marketing Authorization Holders (“MAH”) and competent authorities are given more power to better monitor and control the availability of medicines on the market.

As we have discussed previously, these measures aim to tackle the broader problem of security and robustness of pharmaceutical supply chains, which became especially prominent during the COVID-19 pandemic.  In this blog, we briefly explore some of the changes introduced by the Proposal.

Preventing Supply Disruptions and Shortages

Critical Medicinal Products

The Proposal expands the monitoring of “critical medicinal products” beyond emergency situations.  Now, medicinal products “for which insufficient supply results in serious harm or risk of serious harm to patients” will be included in the “Union list of critical medicinal products” (“Union list”), and the Commission will have the power to implement measures such as stockpiling of active pharmaceutical ingredients or finished dosage forms.  Continue Reading EU Pharma Legislation Review Series: Supply Security and Shortages Control