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In brief

The HMA has published a letter highlighting its plans to collaborate with other European medicines agencies to build knowledge on the approaches taken by member states with a record of effective, consistent trial reporting, with a view to sharing guidance with all member states as to “best practice” clinical trial reporting ahead of the new Clinical Trial Regulation (CTR) and enhanced transparency rules coming into force. The article below sets out the reasoning behind the letter’s publication, as well as an overview of key provisions within the CTR.

  • Joint action: On 8 July, the Heads of Medicines Agencies (HMA) published a letter to TranspariMED announcing plans to initiate joint action with the European Medicines Agency (EMA) and the European Commission (EC) to support the efforts of Member States in improving clinical trial reporting. According to the HMA, the present lack of compliance with long-standing transparency rules is thought to be the result of a “lack of knowledge of the European rules on the part of the sponsors”.
  • The Regulation: The EU’s Clinical Trial Regulation will come into force in all member states on 31 January 2022, and contains enhanced transparency rules. For example, in an effort to “create a landscape that is favourable to conducting clinical trials in the EU” as stated by the EMA, all information stored in the new EU trial registry must be publicy accessible unless its confidentiality can be justified on the basis of a limited number of circumstances, e.g., the protection of commercially confidential information or personal data.. National medicines regulators are responsible for the enforcement of these rules.
  • Why this is important: The data currently available on the EU Clinical Trials Register is largely inconsistent on a country to country basis. A recent report published by TranspariMED found that only 7% of Norwegian single-country trials approved up to 2015 had published their results on the registry, as opposed to the Latvian regulator, whose trials boasted a reporting rate of 73%. In order to facilitate alignment across the EU, the HMA will prepare “best practice” guidance setting out the actions taken by Member States to improve knowledge amongst sponsors in relation to public access to trial results, in the hope that this will encourage national regulators to enforce sponsors’ compliance with obligations.
  • Industry response: The HMA’s letter has been welcomed by industry members and comes in the wake of unrelenting advocacy from health groups urging regulators to facilitate increased compliance in a proactive manner. This announcement from European medicines regulators represents a significant step forward for clinical trial transparency, and will hopefully help to minimise gaps in information on the benefits and harms of medicines.

The HMA’s letter can be read in full here.

For further information, please contact Julia Gillert or Marilyn Acquah of our London office.


Julia Gillert is an Associate in Baker McKenzie's London office.


Marilyn Acquah is a Trainee in Baker McKenzie London office.

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