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New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids

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European Pharmacopoeia
News
03 May 2021
Strasbourg, France

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined API salts and/or API (base/acid).

Separate individual monographs on medicinal products will be developed for each API salt/API base or acid when different approved medicinal products contain the same active moiety but not the same salt form.

For example:

  • Separate monographs will be drafted for XXX phosphate tablets and XXX hydrochloride tablets instead of a single monograph covering tablets obtained from both XXX phosphate and XXX hydrochloride;
  • Separate monographs will be drafted for YYY capsules and YYY hydrochloride capsules instead of a single monograph covering capsules obtained from both YYY and YYY hydrochloride.

This decision was taken because the development work for monographs focuses on quality aspects and not on bioequivalence or clinical interchangeability. The latter is regulated at national level and is not within the remit of the Ph. Eur. The new approach also mirrors the one followed for the development of monographs on active substances (one monograph per API salt/API base or acid).

Consequently, the title of each monograph will clearly state the API salt/API base or acid covered. There are several advantages to this new policy:

  • greater visibility for users as the scope of the monograph will be reflected in the title (no need to go to the Definition to learn about the scope);
  • direct link between the API and medicinal product monographs;
  • greater flexibility in case of development and revision of both API and medicinal product monographs. A new monograph will be developed when a medicinal product containing a new API salt/API base or acid is approved instead of revising the existing monograph to cover the new API salt/API base or acid.

Assay content will still be expressed as a percentage of the labelled active moiety.

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